Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery

Pain, Postoperative Clinical Trial

Official title:

TAP (Transverse Abdominis Plane) Block With Exparel (Liposomal Bupivicaine) vs. Bupivicaine Post-op Pain Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04781075
• Other study ID #: 2017.044 -TAP Block
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2021
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• Pain Scale
Maximum Daily Pain Scale will be recorded daily until discharge (typically under 7 days)

Drug:
• Exparel Injectable Product
Given at the beginning of the surgery for post-operative pain management
• Bupivacaine Injection
Given at the beginning of the surgery for post-operative pain management

Locations

Country	Name	City	State
United States	Ochsner Medical Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scale	Daily Pain Scale using Wong-baker FACES Pain Rating Scale 0 (no pain) - 10 (worst pain imaginable)	daily through study completion (up to 30 days)
Secondary	Length of stay	Duration of hospitalization post-operatively	daily through study completion (up to 30 days)
Secondary	Narcotic use	Total amount of narcotic used for pain control postoperatively	daily through study completion (up to 30 days)