Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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TAP Block with Exparel

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

Group Type EXPERIMENTAL

Pain Scale

Intervention Type OTHER

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

Exparel Injectable Product

Intervention Type DRUG

Given at the beginning of the surgery for post-operative pain management

TAP Block with bupivicaine

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

Group Type ACTIVE_COMPARATOR

Pain Scale

Intervention Type OTHER

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

Bupivacaine Injection

Intervention Type DRUG

Given at the beginning of the surgery for post-operative pain management

Interventions

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Pain Scale

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

Intervention Type OTHER

Exparel Injectable Product

Given at the beginning of the surgery for post-operative pain management

Intervention Type DRUG

Bupivacaine Injection

Given at the beginning of the surgery for post-operative pain management

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes