The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Exparel; Procedure: TAP Block

• Registration Number: NCT02263963
• Lead Sponsor: Spectrum Health Hospitals

Brief Summary

The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2014-10-13
• Study First Posted: 2014-10-15
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2016-04-13
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-31
• Last Update Submitted: 2023-01-31
• Results First Posted: 2023-02-28
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients over the age of 18 years w
2. Elective laparoscopic colorectal resection.

Exclusion Criteria

1. Patients under 18 years.
2. Patients unable to provide informed consent
3. Patients undergoing emergency surgery.
4. Pregnant women
5. Severe liver or kidney disease (GFR 15-29 ml/min)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP Block Experal	TAP Block	Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally.
TAP Block Experal	Exparel	Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Score	participants will be followed for the duration of hospital stay, an expected average of 4 days	Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.

Secondary Outcome Measures

Name	Time	Method
Postoperative Narcotic Use	participants will be followed for the duration of hospital stay, an expected average of 4 days	Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.

Trial Locations

Locations (1)

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States