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Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pain Scale
Exparel Injectable Product
Bupivacaine Injection
Sponsored by
Ochsner Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients age 18-75 years undergoing planned laparoscopic colon or rectal resection

Exclusion Criteria:

  1. Patients younger than 18 or older than 75 years old
  2. Pregnant women
  3. Patients who have taken steroids or other immunomodulators within the last 6 months
  4. Patients on home narcotics
  5. Patients allergic to Exparel or bupivacaine

Sites / Locations

  • Ochsner Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAP Block with Exparel

TAP Block with bupivicaine

Arm Description

TAP Block with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline

TAP Block with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline

Outcomes

Primary Outcome Measures

Pain Scale
Daily Pain Scale using Wong-baker FACES Pain Rating Scale 0 (no pain) - 10 (worst pain imaginable)

Secondary Outcome Measures

Length of stay
Duration of hospitalization post-operatively
Narcotic use
Total amount of narcotic used for pain control postoperatively

Full Information

First Posted
April 11, 2019
Last Updated
September 9, 2021
Sponsor
Ochsner Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04781075
Brief Title
Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery
Official Title
TAP (Transverse Abdominis Plane) Block With Exparel (Liposomal Bupivicaine) vs. Bupivicaine Post-op Pain Management
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ochsner Health System

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Single Blind, Randomized Controlled study to see if TAP Block with Exparel provides better pain relief than TAP Block with bupivicaine. Differences in Pain Scale, Length of Stay, and Total Narcotic use in the hospital will be evaluated.
Detailed Description
Subjects recruited into the study will undergo surgery as scheduled. During the procedure they will receive a TAP Block with one of the pain medications. TAP Block in the experimental arm will be performed with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline. The control arm will have a TAP Block performed with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline. These doses are consistent with prior studies of TAP Block with liposomal bupivacaine. Subjects will be monitored for pain as per standard of care and will be given pain medication as needed. Subject Recruitment and Screening Patients will be recruited from the Ochsner Colorectal Surgery Clinic at the time of a preoperative visit. Study Procedures Screening & Baseline Visit After obtaining informed consent the subjects relevant medical and surgical history will be documented. Demographics and vitals will be documented. Current use of pain medication will be recorded. A physical exam will be performed. Day of Surgery Routine vital signs will be obtained preoperatively. During the operation subject will receive a TAP Block containing their randomized local injection mixture as described above. Following surgery the subject will recover the PACU and pain medication will be provided on demand. Initial postoperative vital signs and pain scores will be obtained at this time. Post-Operative Course Postoperatively subject will have regularly scheduled vital signs and pain scores obtained, and recorded for study use. Narcotic and non-narcotic pain medication will be provided on demand; dosages will be recorded for study use. Subjects will be followed until they are discharged at which time study participation will be complete.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP Block with Exparel
Arm Type
Experimental
Arm Description
TAP Block with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline
Arm Title
TAP Block with bupivicaine
Arm Type
Active Comparator
Arm Description
TAP Block with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline
Intervention Type
Other
Intervention Name(s)
Pain Scale
Intervention Description
Maximum Daily Pain Scale will be recorded daily until discharge (typically under 7 days)
Intervention Type
Drug
Intervention Name(s)
Exparel Injectable Product
Intervention Description
Given at the beginning of the surgery for post-operative pain management
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Intervention Description
Given at the beginning of the surgery for post-operative pain management
Primary Outcome Measure Information:
Title
Pain Scale
Description
Daily Pain Scale using Wong-baker FACES Pain Rating Scale 0 (no pain) - 10 (worst pain imaginable)
Time Frame
daily through study completion (up to 30 days)
Secondary Outcome Measure Information:
Title
Length of stay
Description
Duration of hospitalization post-operatively
Time Frame
daily through study completion (up to 30 days)
Title
Narcotic use
Description
Total amount of narcotic used for pain control postoperatively
Time Frame
daily through study completion (up to 30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients age 18-75 years undergoing planned laparoscopic colon or rectal resection Exclusion Criteria: Patients younger than 18 or older than 75 years old Pregnant women Patients who have taken steroids or other immunomodulators within the last 6 months Patients on home narcotics Patients allergic to Exparel or bupivacaine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Whitlow, MD
Organizational Affiliation
Ochsner
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35849756
Citation
Chevrollier GS, Klinger AL, Green HJ, Gastanaduy MM, Johnston WF, Vargas HD, Kann BR, Whitlow CB, Paruch JL. Liposomal Bupivacaine Transversus Abdominis Plane Blocks in Laparoscopic Colorectal Resections: A Single-Institution Randomized Controlled Trial. Dis Colon Rectum. 2023 Feb 1;66(2):322-330. doi: 10.1097/DCR.0000000000002346. Epub 2022 May 24.
Results Reference
derived

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Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery

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