TOTEM: Trial of TAP Block Effective Medications

Study Overview
=================
Brief Summary
-----------------
Our goal is to determine if liposomal bupivacaine compared to standard bupivacaine results in increased pain control and decreased narcotic pain medication use when used in TAP blocks prior to laparoscopic hysterectomies for benign indications.

Official Title
-----------------
TOTEM: Trial of TAP Block Effective Medications

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing non robotic assisted laparoscopic surgery for benign gynecologic conditions English speaking Exclusion Criteria: Known current malignancy Contraindication to medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP block with liposomal bupivacaine<br>Active comparator | Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine<br>* Transversus abdominis plane (TAP) blocks are safe and effective procedures for the provision of postoperative pain management following abdominal procedures (3) and have been widely used across specialties with reduction in postoperative pain and narcotic use (4-7).<br>|
| Other: TAP block with 0.25% bupivacaine<br>Standard comparator | Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine<br>* Transversus abdominis plane (TAP) blocks are safe and effective procedures for the provision of postoperative pain management following abdominal procedures (3) and have been widely used across specialties with reduction in postoperative pain and narcotic use (4-7).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain rating 1 hour post operation | Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain | 1 hour post operation | 
| Pain rating 2 hours post operation | Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain | 2 hours post operation | 
| Pain rating 4 hours post operation | Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain | 4 hours post operation | 
| Pain rating 72 hours post operation | Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain | 72 hours post operation |