Efficacy Between Serratus Plane Block And Local Infiltration In Vats

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03642457
• Collaborator: (none)
• Enrollment: 65
• Locations: 2
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site: 32.5
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon.

Serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores.

The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance.

The purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Bupivacaine; Drug: Bupivacaine liposome	Phase 4

Detailed Description

Participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. Block team will perform all blocks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: The patient, surgeon, and anesthesiologist in the case will be blinded.
• Primary Purpose: Treatment
• Official Title: Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video Assisted Thoracoscopic Surgery- A Randomised Controlled Trial
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Serratus Plane Group Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.	Drug: Bupivacaine; 20 cc 0.5%; Drug: Bupivacaine liposome; 133mg liposomal bupivacaine
Placebo Comparator: Placebo Group Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.	Drug: Bupivacaine liposome; 133mg liposomal bupivacaine

Outcome Measures

Primary Outcome Measures

1. Amount of Opioid Consumption [up to 24 hours post procedure]

   The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.

Secondary Outcome Measures

1. Time to First Dose of Narcotic Administration [up to 24 hours post procedure]

   Time to first dose of narcotic administration post procedure

2. PACU Length of Stay [average 3-4 hours post procedure]

   The length of stay post procedure in the PACU

3. ICU Length of Stay [up to 40 hours post procedure]

   The length of stay post procedure in the or ICU

4. Visual Analogue Score (VAS) [up to 24 hours post procedure]

   Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain)

5. Patient Satisfaction Score [up to 24 hours post procedure]

   Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• ASA (American Society of Anesthesiology) class I-IV

• age 81-75

Exclusion Criteria:

• ASA class V

• morbid obesity

• patient refusal

• patients with chronic pain or on pain medications

• allergy to LA

• patients receiving any additional regional techniques

• coagulopathy

• patients receiving systemic anticoagulation

• local infection

• procedures anticipated to last more than 5 hours.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai St. Luke's Hospital	New York	New York	United States	10019
2	Mount Sinai West Hospital	New York	New York	United States	10019

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Yan Lai, MD, MPH, cahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 8, 2017

More Information

Publications

• Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x.
• Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
• Thoracic paravertebral block versus pectoral nerve block for analgesia after breast surgery. Egypt J Anaesth. 2013; 30: 129-135. Wahba, SS and Kamal, SM.

• Responsible Party: Yan Lai, Assistant Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03642457
• Other Study ID Numbers: GCO 17-1294
• First Posted: Aug 22, 2018
• Last Update Posted: Sep 30, 2020
• Last Verified: Sep 1, 2020

• 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.: Yes
• Keywords provided by Yan Lai, Assistant Professor, Icahn School of Medicine at Mount Sinai: Video assisted thoracoscopic surgery; Serratus plane block; local infiltration
• Additional relevant MeSH terms: Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Serratus Plane Group	Placebo Group
Arm/Group Description	Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.	Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
Period Title: Overall Study
STARTED	35	30
COMPLETED	35	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Serratus Plane Group	Placebo Group	Total
Arm/Group Description	Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.	Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.	Total of all reporting groups
Overall Participants	35	30	65
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.29 (17.24)	64.30 (11.01)	58.37 (15.60)
Sex: Female, Male (Count of Participants)
Female	18 51.4%	18 60%	36 55.4%
Male	17 48.6%	11 36.7%	28 43.1%
Race/Ethnicity, Customized (Count of Participants)
Asian	10 28.6%	0 0%	10 15.4%
Black or African American	10 28.6%	10 33.3%	20 30.8%
Hispanic or Latino	5 14.3%	10 33.3%	15 23.1%
White	10 28.6%	10 33.3%	20 30.8%

Outcome Measures

1. Primary Outcome

Title	Amount of Opioid Consumption
Description	The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.
Time Frame	up to 24 hours post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Serratus Plane Group	Placebo Group
Arm/Group Description	Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.	Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
Measure Participants	35	30
Mean (Standard Deviation) [MME]	18.93 (19.16)	13.21 (18.93)

2. Secondary Outcome

Title	Time to First Dose of Narcotic Administration
Description	Time to first dose of narcotic administration post procedure
Time Frame	up to 24 hours post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Serratus Plane Group	Placebo Group
Arm/Group Description	Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.	Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
Measure Participants	35	30
Mean (Standard Deviation) [hours]	2.86 (4.17)	3.09 (3.85)

3. Secondary Outcome

Title	PACU Length of Stay
Description	The length of stay post procedure in the PACU
Time Frame	average 3-4 hours post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Serratus Plane Group	Placebo Group
Arm/Group Description	Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.	Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
Measure Participants	35	30
Mean (Standard Deviation) [hours]	3.45 (2.41)	3.05 (1.66)

4. Secondary Outcome

Title	ICU Length of Stay
Description	The length of stay post procedure in the or ICU
Time Frame	up to 40 hours post procedure

Outcome Measure Data

Analysis Population Description

only those participants who required an ICU stay

Arm/Group Title	Serratus Plane Group	Placebo Group
Arm/Group Description	Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.	Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
Measure Participants	7	3
Mean (Standard Deviation) [hours]	32.57 (28.32)	40.00 (27.71)

5. Secondary Outcome

Title	Visual Analogue Score (VAS)
Description	Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain)
Time Frame	up to 24 hours post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Serratus Plane Group	Placebo Group
Arm/Group Description	Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.	Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
Measure Participants	35	30
baseline	2.31 (3.56)	2.80 (3.65)
at 2 hours	3.09 (2.85)	3.07 (2.57)
at 6 hours	3.03 (2.71)	3.23 (3.02)
at 18 hours	2.17 (2.94)	2.17 (2.73)
at 24 hours	1.89 (2.26)	1.93 (2.57)

6. Secondary Outcome

Title	Patient Satisfaction Score
Description	Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied)
Time Frame	up to 24 hours post procedure

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	Serratus Plane Group	Placebo Group
Arm/Group Description	Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.	Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
Measure Participants	0	0

Adverse Events

Time Frame	2 days
Arm/Group Title	Serratus Plane Group		Placebo Group
Arm/Group Description	Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.		Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
All Cause Mortality
	Serratus Plane Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/30 (0%)
Serious Adverse Events
	Serratus Plane Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Serratus Plane Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.