Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
Sponsor
Temple University (Other)
Overall Status
Completed
CT.gov ID
NCT04919317
Collaborator
(none)
56
1
2
37.9
1.5
Study Details
Study Description
Brief Summary
The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been investigated in any types of breast surgery. The investigators assessed if the combination of dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast reduction surgery resulted in improved pain control relative to bupivacaine alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The investigators conducted a double-blind randomized controlled trial to determine whether the addition of dexamethasone to bupivacaine in a preoperative Pecs II block resulted in improved pain control, relative to bupivacaine alone, in patients undergoing bilateral reduction mammaplasty.
Using a preassigned randomization list, patients were randomized to experimental and control groups in a ratio of 1:1 upon enrollment. Both groups received PECS II bupivacaine field blocks in the preoperative holding area, performed by an acute pain fellowship-trained anesthesiologist. The experimental group received 29mL of 0.5% bupivacaine mixed with 1mL 4mg/mL dexamethasone per side. The control group received 29mL 0.5% bupivacaine mixed with 1mL 0.9 saline solution per side. To maintain the blinded aspect of the study, the anesthesiologists were given pre-mixed vials labelled uniformly for the trial, regardless of the patient's treatment arm.
The patients all underwent bilateral breast reduction with a single surgeon. Postoperative pain regimens were standardized. Subjective pain scores, narcotic consumption, 4-hour interval vital signs, anti-emetic usage, and postoperative quality of life via an sf-36 questionnaire were all recorded per patient.
Study Design
Study Type:
Interventional
Actual Enrollment
:
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-blinded randomized controlled trial. Subjects were randomized 1:1 to the experimental or control groups. Each patient received the same Pecs II perineural block preoperatively with the same volume injected. Experimental group patients received 29mL 0.5% bupivacaine with 1mL of 4mg/mL dexamethasone, while control group patients received 29mL 0.5% bupivacaine with 1mL of 0.9% saline.Double-blinded randomized controlled trial. Subjects were randomized 1:1 to the experimental or control groups. Each patient received the same Pecs II perineural block preoperatively with the same volume injected. Experimental group patients received 29mL 0.5% bupivacaine with 1mL of 4mg/mL dexamethasone, while control group patients received 29mL 0.5% bupivacaine with 1mL of 0.9% saline.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
The surgeon (investigator), patient, and anesthesiologists were not aware of which arm each participant was assigned to. Furthermore, each injected analgesic was premixed and uniformly labeled to maintain blinding.
Primary Purpose:
Treatment
Official Title:
Enhanced Pain Control After Reduction Mammaplasty With Bupivicaine and Dexamethasone Regional Block: a Double-blind Randomized Controlled Trial
Actual Study Start Date
:
Sep 29, 2017
Actual Primary Completion Date
:
Nov 7, 2020
Actual Study Completion Date
:
Nov 25, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Control Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
Drug: Saline
The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
|
| Experimental: Experimental Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
Drug: Dexamethasone 4mg
The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
|
Outcome Measures
Primary Outcome Measures
- Initial Visual Analog Scale (VAS) Pain Scores [Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)]
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
- 4-hour Visual Analog Scale (VAS) Pain Scores [Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)]
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
- 8-hour Visual Analog Scale (VAS) Pain Scores [Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)]
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
- 12-hour Visual Analog Scale (VAS) Pain Scores [Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)]
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
- 16-hour Visual Analog Scale (VAS) Pain Scores [Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)]
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
- 20-hour Visual Analog Scale (VAS) Pain Scores [Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)]
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
- 24-hour Visual Analog Scale (VAS) Pain Scores [Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)]
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
- Narcotic Consumption [Up to 24 hours postoperatively]
Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization
Secondary Outcome Measures
- Initial Blood Pressure [Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)]
Systolic blood pressure
- 4-hour Blood Pressure [Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)]
Systolic blood pressure
- 8-hour Blood Pressure [Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)]
Systolic blood pressure
- 12-hour Blood Pressure [Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)]
Systolic blood pressure
- 16-hour Blood Pressure [Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)]
Systolic blood pressure
- 20-hour Blood Pressure [Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)]
Systolic blood pressure
- 24-hour Blood Pressure [Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)]
Systolic blood pressure
- Initial Oxygen Saturation [Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)]
SpO2 as measured by pulse oximetry
- 4-hour Oxygen Saturation [Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)]
SpO2 as measured by pulse oximetry
- 8-hour Oxygen Saturation [Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)]
SpO2 as measured by pulse oximetry
- 12-hour Oxygen Saturation [Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)]
SpO2 as measured by pulse oximetry
- 16-hour Oxygen Saturation [Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)]
SpO2 as measured by pulse oximetry
- 20-hour Oxygen Saturation [Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)]
SpO2 as measured by pulse oximetry
- 24-hour Oxygen Saturation [Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)]
SpO2 as measured by pulse oximetry
- Number of Patients Administered Anti-emetics at 4-hour Intervals [Initial, 4, 8, 12, 16, 20, and 24 hours]
Frequency of anti-emetics administered for complaints of nausea or vomiting at 4-hour intervals
- Short-form 36-item (Sf-36) Quality of Life Questionnaire [1 week to 2 months postoperatively]
Aggregate results of the sf-36 quality of life assessment. This was provided one time to each patient, as early as at the first postoperative visit or at any time thereafter up to 2 months postoperatively. This assessment has been validated to measure 8 categories related to quality of life: physical functioning, limitations due to physical health, limitations due to emotional health, perceived level of energy/fatigue, emotional well-being, social functioning, pain, and overall general health. The responses to the 36 questions are tabulated and each category is given a score from 1-100 for each individual patient. Higher scores indicate a better quality of life for that category. The rows/data below report the mean and standard deviations of the collected scores in each category.
- Rate of Wound Complications [1 week to 2 months postoperatively]
Assessment of wound complications during any postoperative clinic visit
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Female
-
Age 18-80
-
Bilateral reduction mammaplasty
-
American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
-
Must choose to receive preoperative nerve block as part of pain management strategy
Exclusion Criteria:
-
Allergy to dexamethasone or bupivacaine
-
History of postoperative nausea and vomiting following anesthesia
-
History of chronic pain conditions
-
History of narcotic abuse or dependency
-
History of chronic renal disease
-
History of chronic liver disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
Sponsors and Collaborators
- Temple University
Investigators
- Principal Investigator: Andrew A Gassman, MD, FACS, Lewis Katz School of Medicine at Temple University
Study Documents (Full-Text)
More Information
Publications
- Ahiskalioglu A, Yayik AM, Demir U, Ahiskalioglu EO, Celik EC, Ekinci M, Celik M, Cinal H, Tan O, Aydin ME. Preemptive Analgesic Efficacy of the Ultrasound-Guided Bilateral Superficial Serratus Plane Block on Postoperative Pain in Breast Reduction Surgery: A Prospective Randomized Controlled Study. Aesthetic Plast Surg. 2020 Feb;44(1):37-44. doi: 10.1007/s00266-019-01542-y. Epub 2019 Nov 18.
- Bjørn S, Linde F, Nielsen KK, Børglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.
- Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
- Broyles JM, Tuffaha SH, Williams EH, Glickman L, George TA, Lee Dellon A. Pain after breast surgery: Etiology, diagnosis, and definitive management. Microsurgery. 2016 Oct;36(7):535-538. doi: 10.1002/micr.30055. Epub 2016 Apr 4.
- Ibrahim AS, Aly MG, Farrag WS, Gad El-Rab NA, Said HG, Saad AH. Ultrasound-guided adductor canal block after arthroscopic anterior cruciate ligament reconstruction: Effect of adding dexamethasone to bupivacaine, a randomized controlled trial. Eur J Pain. 2019 Jan;23(1):135-141. doi: 10.1002/ejp.1292. Epub 2018 Aug 6.
- Maher DP, Serna-Gallegos D, Mardirosian R, Thomas OJ, Zhang X, McKenna R, Yumul R, Zhang V. The Combination of IV and Perineural Dexamethasone Prolongs the Analgesic Duration of Intercostal Nerve Blocks Compared with IV Dexamethasone Alone. Pain Med. 2017 Jun 1;18(6):1152-1160. doi: 10.1093/pm/pnw149.
- Vetriselvan P, Mandal B, Bhatia N, Jain V. Effect of dexamethasone on analgesic efficacy of transverse abdominis plane block in laparoscopic gynecological procedures: A prospective randomized clinical study. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):165-169. doi: 10.4103/joacp.JOACP_374_17.
- Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205.
Responsible Party:
Temple University
ClinicalTrials.gov Identifier:
NCT04919317
Other Study ID Numbers:
- 24361
First Posted:
Jun 9, 2021
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Period Title: Hospitalization and Wound Follow-up | ||
| STARTED | 26 | 30 |
| COMPLETED | 26 | 25 |
| NOT COMPLETED | 0 | 5 |
| Period Title: Hospitalization and Wound Follow-up | ||
| STARTED | 26 | 25 |
| COMPLETED | 14 | 19 |
| NOT COMPLETED | 12 | 6 |
Baseline Characteristics
| Arm/Group Title | Control | Experimental | Total |
|---|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Total of all reporting groups |
| Overall Participants | 26 | 25 | 51 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
38.73
(13.44)
|
42.48
(15.17)
|
40.57
(14.29)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
26
100%
|
25
100%
|
51
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
10
38.5%
|
8
32%
|
18
35.3%
|
| Not Hispanic or Latino |
16
61.5%
|
16
64%
|
32
62.7%
|
| Unknown or Not Reported |
0
0%
|
1
4%
|
1
2%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
15
57.7%
|
12
48%
|
27
52.9%
|
| White |
2
7.7%
|
6
24%
|
8
15.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
9
34.6%
|
7
28%
|
16
31.4%
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
32.65
(10.12)
|
34.12
(13.99)
|
33.37
(12.07)
|
| Anemia (Count of Participants) | |||
| Count of Participants [Participants] |
4
15.4%
|
5
20%
|
9
17.6%
|
| Anxiety (Count of Participants) | |||
| Count of Participants [Participants] |
4
15.4%
|
5
20%
|
9
17.6%
|
| Asthma (Count of Participants) | |||
| Count of Participants [Participants] |
4
15.4%
|
7
28%
|
11
21.6%
|
| Depression (Count of Participants) | |||
| Count of Participants [Participants] |
5
19.2%
|
3
12%
|
8
15.7%
|
| Degenerative Disc Disease (Count of Participants) | |||
| Count of Participants [Participants] |
1
3.8%
|
1
4%
|
2
3.9%
|
| Degenerative Joint Disease (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
2
8%
|
2
3.9%
|
| Diabetes (Count of Participants) | |||
| Count of Participants [Participants] |
3
11.5%
|
2
8%
|
5
9.8%
|
| Drug Abuse (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
1
4%
|
1
2%
|
| Gastroesophaageal reflux disease (GERD) (Count of Participants) | |||
| Count of Participants [Participants] |
1
3.8%
|
4
16%
|
5
9.8%
|
| Hypothyroidism (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
3
12%
|
3
5.9%
|
| Hyperlipidemia (Count of Participants) | |||
| Count of Participants [Participants] |
1
3.8%
|
4
16%
|
5
9.8%
|
| Human immunodeficiency virus infection (HIV) / Acquired immunodeficiency syndrome AIDS (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
1
4%
|
1
2%
|
| Hypertension (Count of Participants) | |||
| Count of Participants [Participants] |
3
11.5%
|
6
24%
|
9
17.6%
|
| Insomnia (Count of Participants) | |||
| Count of Participants [Participants] |
1
3.8%
|
1
4%
|
2
3.9%
|
| Migraines (Count of Participants) | |||
| Count of Participants [Participants] |
1
3.8%
|
5
20%
|
6
11.8%
|
| Polycystic ovaries (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
1
4%
|
1
2%
|
| Uterine Fibroids (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
1
4%
|
1
2%
|
| Abnormal Uterine Bleeding (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
1
4%
|
1
2%
|
| Rheumatoid Arthritis (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
1
4%
|
1
2%
|
Outcome Measures
| Title | Initial Visual Analog Scale (VAS) Pain Scores |
|---|---|
| Description | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| Time Frame | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 26 | 25 |
| Mean (Standard Deviation) [score on a scale] |
8.3
(1.5)
|
7.4
(2.1)
|
| Title | 4-hour Visual Analog Scale (VAS) Pain Scores |
|---|---|
| Description | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| Time Frame | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 26 | 25 |
| Mean (Standard Deviation) [score on a scale] |
5.5
(3.5)
|
4.6
(3.6)
|
| Title | 8-hour Visual Analog Scale (VAS) Pain Scores |
|---|---|
| Description | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| Time Frame | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 26 | 25 |
| Mean (Standard Deviation) [score on a scale] |
4.4
(3.9)
|
3.5
(3.6)
|
| Title | 12-hour Visual Analog Scale (VAS) Pain Scores |
|---|---|
| Description | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| Time Frame | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Between the prior time point and this time point, 8 patients from the experimental group had been discharged to home |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 26 | 17 |
| Mean (Standard Deviation) [score on a scale] |
3.9
(3.7)
|
3.4
(3.6)
|
| Title | 16-hour Visual Analog Scale (VAS) Pain Scores |
|---|---|
| Description | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| Time Frame | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Between the prior time point and this time point, 9 patients in the control group and 2 patients from the experimental group had been discharged to home |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 17 | 15 |
| Mean (Standard Deviation) [score on a scale] |
5.6
(2.8)
|
5.4
(2.8)
|
| Title | 20-hour Visual Analog Scale (VAS) Pain Scores |
|---|---|
| Description | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| Time Frame | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Between the prior time point and this time point, 7 patients in the control group and 4 patients from the experimental group had been discharged to home |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 10 | 11 |
| Mean (Standard Deviation) [score on a scale] |
5.8
(3.4)
|
4.9
(3.8)
|
| Title | 24-hour Visual Analog Scale (VAS) Pain Scores |
|---|---|
| Description | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| Time Frame | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Between the prior time point and this time point, 4 patients in the control group and 6 patients from the experimental group had been discharged to home |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 6 | 5 |
| Mean (Standard Deviation) [score on a scale] |
5.2
(3.8)
|
8
(1.4)
|
| Title | Narcotic Consumption |
|---|---|
| Description | Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization |
| Time Frame | Up to 24 hours postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 26 | 25 |
| Mean (Standard Deviation) [Oral Morphine Equivalents (OME)] |
36.60
(23.99)
|
23.19
(17.26)
|
| Title | Initial Blood Pressure |
|---|---|
| Description | Systolic blood pressure |
| Time Frame | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 24 | 25 |
| Mean (Standard Deviation) [mmHg] |
124.2
(14.8)
|
123.8
(13.5)
|
| Title | 4-hour Blood Pressure |
|---|---|
| Description | Systolic blood pressure |
| Time Frame | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 18 | 19 |
| Mean (Standard Deviation) [mmHg] |
118.0
(10.8)
|
119.6
(16.4)
|
| Title | 8-hour Blood Pressure |
|---|---|
| Description | Systolic blood pressure |
| Time Frame | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 20 | 19 |
| Mean (Standard Deviation) [mmHg] |
113.8
(12.2)
|
117.9
(17.4)
|
| Title | 12-hour Blood Pressure |
|---|---|
| Description | Systolic blood pressure |
| Time Frame | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 18 | 23 |
| Mean (Standard Deviation) [mmHg] |
106.7
(8.6)
|
112.0
(17.8)
|
| Title | 16-hour Blood Pressure |
|---|---|
| Description | Systolic blood pressure |
| Time Frame | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 16 | 19 |
| Mean (Standard Deviation) [mmHg] |
112.3
(13.6)
|
104.2
(8.0)
|
| Title | 20-hour Blood Pressure |
|---|---|
| Description | Systolic blood pressure |
| Time Frame | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 13 | 15 |
| Mean (Standard Deviation) [mmHg] |
106.5
(12.5)
|
114.7
(9.6)
|
| Title | 24-hour Blood Pressure |
|---|---|
| Description | Systolic blood pressure |
| Time Frame | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 3 | 3 |
| Mean (Standard Deviation) [mmHg] |
108.7
(8.5)
|
118.3
(24.5)
|
| Title | Initial Oxygen Saturation |
|---|---|
| Description | SpO2 as measured by pulse oximetry |
| Time Frame | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 23 | 23 |
| Mean (Standard Deviation) [percentage of blood oxygen saturation] |
99.4
(1.1)
|
98.6
(2.1)
|
| Title | 4-hour Oxygen Saturation |
|---|---|
| Description | SpO2 as measured by pulse oximetry |
| Time Frame | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 18 | 19 |
| Mean (Standard Deviation) [percentage of blood oxygen saturation] |
97.8
(1.6)
|
96.9
(1.7)
|
| Title | 8-hour Oxygen Saturation |
|---|---|
| Description | SpO2 as measured by pulse oximetry |
| Time Frame | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 20 | 19 |
| Mean (Standard Deviation) [percentage of blood oxygen saturation] |
98.7
(1.4)
|
96.5
(2.0)
|
| Title | 12-hour Oxygen Saturation |
|---|---|
| Description | SpO2 as measured by pulse oximetry |
| Time Frame | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 18 | 23 |
| Mean (Standard Deviation) [percentage of blood oxygen saturation] |
97.8
(1.5)
|
97.0
(2.1)
|
| Title | 16-hour Oxygen Saturation |
|---|---|
| Description | SpO2 as measured by pulse oximetry |
| Time Frame | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 16 | 19 |
| Mean (Standard Deviation) [percentage of blood oxygen saturation] |
98.8
(1.2)
|
96.9
(1.6)
|
| Title | 20-hour Oxygen Saturation |
|---|---|
| Description | SpO2 as measured by pulse oximetry |
| Time Frame | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 12 | 13 |
| Mean (Standard Deviation) [percentage of blood oxygen saturation] |
99.0
(0.9)
|
98.3
(1.9)
|
| Title | 24-hour Oxygen Saturation |
|---|---|
| Description | SpO2 as measured by pulse oximetry |
| Time Frame | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 3 | 3 |
| Mean (Standard Deviation) [percentage of blood oxygen saturation] |
99.3
(0.6)
|
97.3
(3.1)
|
| Title | Number of Patients Administered Anti-emetics at 4-hour Intervals |
|---|---|
| Description | Frequency of anti-emetics administered for complaints of nausea or vomiting at 4-hour intervals |
| Time Frame | Initial, 4, 8, 12, 16, 20, and 24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 26 | 25 |
| Initial |
4
15.4%
|
5
20%
|
| 4-hours postoperatively |
7
26.9%
|
2
8%
|
| 8-hours postoperatively |
2
7.7%
|
1
4%
|
| 12-hours postoperatively |
4
15.4%
|
0
0%
|
| 16-hours postoperatively |
0
0%
|
0
0%
|
| 20-hours postoperatively |
0
0%
|
0
0%
|
| 24-hours postoperatively |
0
0%
|
0
0%
|
| Title | Short-form 36-item (Sf-36) Quality of Life Questionnaire |
|---|---|
| Description | Aggregate results of the sf-36 quality of life assessment. This was provided one time to each patient, as early as at the first postoperative visit or at any time thereafter up to 2 months postoperatively. This assessment has been validated to measure 8 categories related to quality of life: physical functioning, limitations due to physical health, limitations due to emotional health, perceived level of energy/fatigue, emotional well-being, social functioning, pain, and overall general health. The responses to the 36 questions are tabulated and each category is given a score from 1-100 for each individual patient. Higher scores indicate a better quality of life for that category. The rows/data below report the mean and standard deviations of the collected scores in each category. |
| Time Frame | 1 week to 2 months postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 14 | 19 |
| Physical Functioning |
88.93
(15.83)
|
90.42
(13.98)
|
| Limitations Due to Physical Health |
82.14
(24.86)
|
79.17
(32.61)
|
| Limitations Due to Emotional Health |
88.10
(28.06)
|
80.56
(32.04)
|
| Energy/Fatigue |
54.64
(12.63)
|
52.92
(16.61)
|
| Emotional Well-being |
65.71
(6.41)
|
59.00
(13.16)
|
| Social Functioning |
92.50
(9.71)
|
88.75
(16.70)
|
| Pain |
59.64
(35.84)
|
64.42
(25.16)
|
| Overall General Health |
51.43
(13.36)
|
56.25
(13.69)
|
| Title | Rate of Wound Complications |
|---|---|
| Description | Assessment of wound complications during any postoperative clinic visit |
| Time Frame | 1 week to 2 months postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Experimental |
|---|---|---|
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Measure Participants | 26 | 25 |
| None |
19
73.1%
|
19
76%
|
| Minor |
5
19.2%
|
3
12%
|
| Moderate |
2
7.7%
|
2
8%
|
| Severe |
0
0%
|
1
4%
|
Adverse Events
| Time Frame | 2 months postoperatively | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Other adverse event: wound complications of any severity | |||
| Arm/Group Title | Control | Experimental | ||
| Arm/Group Description | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | ||
All Cause Mortality |
||||
| Control | Experimental | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 0/25 (0%) | ||
Serious Adverse Events |
||||
| Control | Experimental | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 0/25 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Control | Experimental | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/26 (26.9%) | 8/25 (32%) | ||
| Surgical and medical procedures | ||||
| Wound complications | 7/26 (26.9%) | 8/25 (32%) | ||
Limitations/Caveats
Single-center study, which may limit the generalizability of the results The patient population is predominantly composed of racial minority communities, which may also limit the generalizability to many institutions Low SF-36 completion limited an adequate determination of the effects of the block on quality of life metrics. Some SF-36 questionnaires were completed by phone interview The COVID-19 pandemic halted enrollment for four months, which may have imposed a selection bias
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | George Taylor, MD, MS; surgical resident |
|---|---|
| Organization | Temple University Hospital |
| Phone | 2678150512 |
| George.Taylor@tuhs.temple.edu |
Responsible Party:
Temple University
ClinicalTrials.gov Identifier:
NCT04919317
Other Study ID Numbers:
- 24361
First Posted:
Jun 9, 2021
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022