Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03700970
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.6
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.

Condition or Disease	Intervention/Treatment	Phase
Breast Reconstruction; Anesthesia; Transverse Abdominis Plane Block	Drug: Liposomal bupivacaine; Drug: Regular bupivacaine	Phase 4

Detailed Description

Transversus Abdominis Plane (TAP) blocks are commonly used as part of Enhanced Recovery After Surgery (ERAS) pathway. This prospective, double-blinded, randomized control trial compares post-operative pain and narcotic consumption after deep inferior epigastric artery perforator (DIEP) breast reconstruction with liposomal bupivacaine (LB) compared to bupivacaine hydrochloride (BHCl). Subjects undergoing DIEP flaps were randomly assigned LB or BHCl, performed using ultrasound-guided TAP block technique pre-procedurally. Primary outcomes were postoperative narcotic analgesia required in oral morphine equivalents (OME) from postoperative day (POD) 0 to 7. Secondary outcomes included POD 1-7 pain Numeric Rating Scale (NRS), non-narcotic pain medication consumption, time to first narcotic use, return of bowel function, and length of stay (LOS).

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: Participants and plastic surgeons will be blinded to the study treatment arm
• Primary Purpose: Treatment
• Official Title: Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and Bupivacaine Hydrochloride in Transversus Abdominis Plane Blocks Prior To DIEP Flap for Breast Reconstruction
• Actual Study Start Date: Jun 13, 2019
• Actual Primary Completion Date: Mar 15, 2021
• Actual Study Completion Date: Mar 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAP block with liposomal bupivacaine Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Drug: Liposomal bupivacaine; 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.; Other Names: LB
Active Comparator: TAP block with regular bupivacaine Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.	Drug: Regular bupivacaine; 20mL of 0.25% bupivacaine injected on each side.; Other Names: Bupivacaine HCl

Outcome Measures

Primary Outcome Measures

1. Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME) [Postoperative day (POD) 1 to 7]

   Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents

Secondary Outcome Measures

1. Pain Measure [Post operative day (POD) 1 to 7]

   Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).

2. Time to First Opiate Use [0-29.8 hours post operation]

   Time from end of surgery to time of first opioid intake measured in hours

3. Time to Return of Bowel Function [1 to 4 days post operation]

   Mean time in days at which patients had a return of bowel movement post op

4. Length of Stay [1 to 4 days]

   Length of hospital stay post operatively

5. Ambulation [1 day post op]

   Time to first ambulate post op (in days)

6. Non-narcotic Pain Medication Intake: Acetaminophen [Post op day 1 to 7]

   The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization

7. Non Narcotic Pain Medication Intake: Cyclobenzaprine [Post op day 1 to 7]

   The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization

8. Non Narcotic Pain Medication Intake: Gabapentin [Post op day 1 to 7]

   The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization

9. Non Narcotic Pain Medication Intake: Celebrex [post op day 1 to 7]

   The total use of the non-narcotic pain medication celebrex was recorded during hospitalization

10. Non Narcotic Pain Medication Intake: Ondansetron [Post op day 1 to 7]

    The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. age between 18-85 years

2. males or females

3. plastic surgery for abdominally-based free flap breast reconstruction.

Exclusion Criteria:

1. those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)

2. those with anatomic contra-indications to performing a TAP block

3. those unwilling to participate in follow-up assessments

4. vulnerable populations

5. chronic pain or associated diagnosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212

Sponsors and Collaborators

• Vanderbilt University Medical Center

Investigators

• Principal Investigator: Galen Perdikis, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

• Study Protocol - Oct 1, 2018
• Statistical Analysis Plan - Oct 1, 2018
• Informed Consent Form - Jul 18, 2019

More Information

Publications

None provided.

• Responsible Party: Galen Perdikis, Chair and Professor of Surgery Department of Plastic Surgery, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03700970
• Other Study ID Numbers: 180421
• First Posted: Oct 9, 2018
• Last Update Posted: Jan 24, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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.: No
• Additional relevant MeSH terms: Bupivacaine

Study Results

Participant Flow

Arm/Group Title	TAP Block With Liposomal Bupivacaine	TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Period Title: Overall Study
STARTED	30	30
COMPLETED	21	19
NOT COMPLETED	9	11

Baseline Characteristics

Arm/Group Title	Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine	Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine	Total
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (9.5)	52.2 (9.8)	52.6 (9.6)
Sex: Female, Male (Count of Participants)
Female	30 100%	30 100%	60 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Body mass index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.6 (5.3)	30.2 (4.3)	29.9 (4.8)
Smoker (Count of Participants)
Count of Participants [Participants]	1 3.3%	0 0%	1 1.7%
Diabetic (Count of Participants)
Count of Participants [Participants]	8 26.7%	6 20%	14 23.3%
Hypertension (HTN) (Count of Participants)
Count of Participants [Participants]	9 30%	10 33.3%	19 31.7%
Hypercoagulable states (Count of Participants)
Count of Participants [Participants]	1 3.3%	0 0%	1 1.7%
History of hormonal therapy (HT) (Count of Participants)
None	12 40%	17 56.7%	29 48.3%
Prior HT	5 16.7%	3 10%	8 13.3%
Current HT	13 43.3%	10 33.3%	23 38.3%
Prior radiation (Count of Participants)
Count of Participants [Participants]	6 20%	10 33.3%	16 26.7%
Immunosuppressive medications (Count of Participants)
Count of Participants [Participants]	1 3.3%	1 3.3%	2 3.3%
Prior chemotherapy (Count of Participants)
Count of Participants [Participants]	10 33.3%	10 33.3%	20 33.3%
Deep Inferior Epigastric Artery Perforator (DIEP) Laterality (Count of Participants)
Unilateral DIEP	9 30%	7 23.3%	16 26.7%
Bilateral DIEP	21 70%	23 76.7%	44 73.3%
DIEP timing (Count of Participants)
Immediate DIEP	5 16.7%	6 20%	11 18.3%
Delayed DIEP	25 83.3%	24 80%	49 81.7%

Outcome Measures

1. Primary Outcome

Title	Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
Description	Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents
Time Frame	Postoperative day (POD) 1 to 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine	Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Measure Participants	30	30
POD 1	19.8 (18.8)	23.6 (17.5)
POD 2	20.7 (20.5)	25.2 (23.5)
POD 3	12.2 (15.3)	12.8 (11.7)
POD 4	8.2 (8.7)	8.8 (9.3)
POD 5	7.33 (8.48)	6.52 (8.51)
POD 6	5.1 (7.0)	6.8 (7.7)
POD 7	3.8 (5.9)	4.9 (7.7)

2. Secondary Outcome

Title	Pain Measure
Description	Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).
Time Frame	Post operative day (POD) 1 to 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block With Liposomal Bupivacaine	TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Measure Participants	30	30
POD 1	2.43 (1.98)	2.93 (2.80)
POD 2	2 (1.7)	3.1 (3)
POD 3	2.9 (2.3)	3.1 (2.5)
POD 4	2.9 (2.2)	3.1 (2.7)
POD 5	2.6 (2.2)	3.1 (2.6)
POD 6	2.3 (2.1)	3.2 (2.7)
POD 7	2.3 (2.3)	2.8 (2.5)

3. Secondary Outcome

Title	Time to First Opiate Use
Description	Time from end of surgery to time of first opioid intake measured in hours
Time Frame	0-29.8 hours post operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block With Liposomal Bupivacaine	TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Measure Participants	30	30
Mean (Standard Deviation) [hours]	12.4 (17.4)	8.2 (19.8)

4. Secondary Outcome

Title	Time to Return of Bowel Function
Description	Mean time in days at which patients had a return of bowel movement post op
Time Frame	1 to 4 days post operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block With Liposomal Bupivacaine	TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Measure Participants	30	30
Mean (Standard Deviation) [days]	2.62 (0.97)	2.58 (0.97)

5. Secondary Outcome

Title	Length of Stay
Description	Length of hospital stay post operatively
Time Frame	1 to 4 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block With Liposomal Bupivacaine	TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Measure Participants	30	30
Mean (Standard Deviation) [DAYS]	2.43 (0.77)	2.23 (0.43)

6. Secondary Outcome

Title	Ambulation
Description	Time to first ambulate post op (in days)
Time Frame	1 day post op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block With Liposomal Bupivacaine	TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Measure Participants	30	30
Mean (Standard Deviation) [days]	1 (0)	1 (0)

7. Secondary Outcome

Title	Non-narcotic Pain Medication Intake: Acetaminophen
Description	The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization
Time Frame	Post op day 1 to 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block With Liposomal Bupivacaine	TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Measure Participants	30	30
POD 1	2630 (803)	2840 (503)
POD 2	2937 (972)	2868 (799)
POD 3	2160 (1334)	1945 (1342)
POD 4	1937 (1239)	1722 (116)
POD 5	1757 (1159)	1755 (1130)
POD 6	1903 (1179)	1755 (1067)
POD 7	1887 (1174)	1588 (1171)

8. Secondary Outcome

Title	Non Narcotic Pain Medication Intake: Cyclobenzaprine
Description	The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization
Time Frame	Post op day 1 to 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block With Liposomal Bupivacaine	TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Measure Participants	30	30
POD 1	0.5 (1.5)	1.2 (5.5)
POD 2	2 (4.3)	1.2 (4.1)
POD 3	2.5 (4.9)	1.5 (4.4)
POD 4	3.7 (8.1)	1.7 (4.8)
POD 5	3.7 (7.2)	1.8 (4.8)
POD 6	4 (8.3)	1.8 (4.8)
POD 7	3 (6.8)	2.2 (5)

9. Secondary Outcome

Title	Non Narcotic Pain Medication Intake: Gabapentin
Description	The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization
Time Frame	Post op day 1 to 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block With Liposomal Bupivacaine	TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Measure Participants	30	30
POD 1	730 (315)	750 (298)
POD 2	807 (358)	813 (356)
POD 3	680 (489)	577 (378)
POD 4	603 (454)	517 (371)
POD 5	537 (451)	583 (397)
POD 6	503 (453)	560 (443)
POD 7	457 (449)	527 (445)

10. Secondary Outcome

Title	Non Narcotic Pain Medication Intake: Celebrex
Description	The total use of the non-narcotic pain medication celebrex was recorded during hospitalization
Time Frame	post op day 1 to 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block With Liposomal Bupivacaine	TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Measure Participants	30	30
POD 1	200 (144)	187 (138)
POD 2	193 (146)	203 (119)
POD 3	67 (132)	60 (113)
POD 4	20 (61)	0 (0)
POD 5	20 (61)	0 (0)
POD 6	13 (51)	0 (0)
POD 7	13 (51)	0 (0)

11. Secondary Outcome

Title	Non Narcotic Pain Medication Intake: Ondansetron
Description	The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization
Time Frame	Post op day 1 to 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Block With Liposomal Bupivacaine	TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Measure Participants	30	30
POD 1	1.3 (2.6)	2.3 (3.3)
POD 2	0.4 (1.6)	0.4 (1.2)
POD 3	0.27 (1.46)	0.27 (1.01)
POD 4	0 (0)	0 (0)
POD 5	0 (0)	0 (0)
POD 6	0 (0)	0 (0)
POD 7	0 (0)	0 (0)

Adverse Events

Time Frame	6 months
Arm/Group Title	TAP Block With Liposomal Bupivacaine		TAP Block With Regular Bupivacaine
Arm/Group Description	Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.		Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
All Cause Mortality
	TAP Block With Liposomal Bupivacaine		TAP Block With Regular Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	TAP Block With Liposomal Bupivacaine		TAP Block With Regular Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	TAP Block With Liposomal Bupivacaine		TAP Block With Regular Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Blood and lymphatic system disorders
Bupivacaine toxicity	0/30 (0%)		0/30 (0%)
Narcotic complication	0/30 (0%)		0/30 (0%)
Renal and urinary disorders
Urinary retention	0/30 (0%)		0/30 (0%)
Skin and subcutaneous tissue disorders
Flap loss	0/30 (0%)		0/30 (0%)

Limitations/Caveats

If a patient was unable to be reached, they were given a log to record pain scores and medication intake. There may be a recall bias if those patients were unable to adhere to the protocol to record daily and retroactively logged their scores and number of tablets taken. Another limitation is the reliance of certain outcomes on subjective data (i.e. Numeric Pain Scale scores).

More Information

Certain Agreements

Principal Investigators are NOT 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.