Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

Study Overview
=================
Brief Summary
-----------------
The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.

Detailed Description
-----------------
After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP. Blocks will occur post induction and pre incision. Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. The entire care team and the patient will be blinded. A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.

Official Title
-----------------
Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial

Conditions
-----------------
Fibroid Uterus

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Bupivacaine liposome
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not pregnant Weight over 50kg presenting for open myomectomy No history of allergy to any study medication No history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas No history of drug or alcohol use or abuse disorder or pre-existing liver disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Bupivacaine TAP<br>TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side | Drug: Bupivacaine<br>* 0.25%<br>Drug: normal saline<br>* 10ml<br>|
| Experimental: Liposomal bupivacaine TAP<br>TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side | Drug: Bupivacaine<br>* 0.25%<br>Drug: Bupivacaine liposome<br>* 10mL<br>Drug: normal saline<br>* 10ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Equivalents at 72 Hours | Total cumulative opiates consumed converted to morphine equivalents | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Equivalents at 96 Hours | Total cumulative opiates consumed converted to morphine equivalents | 96 hours | 
| Morphine Equivalents at 48 Hours | Total cumulative opiates consumed converted to morphine equivalents | 48 hours | 
| Opiate Sparing Criteria at 72 hours | Composite score of minimal opiate dose and additionally scores of 0 on questions 2,3,4,5,6 on OBAS scoring scale. Overall Benefit of Analgesic Score (OBAS) scoring scale -total scale from 0-20, low score indicates high benefit. | 72 hours | 
| Quality of Recovery at 48 hours | 15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery. | 48 hours | 
| Quality of Recovery at 72 hours | 15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery. | 72 hours | 
| Area under the curve pain scale at 96 hours | Sum of pain scores at 24, 48, 72, and 96 hours. Pain scale from 0-10, with higher score indicating worst pain. | 96 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibroid uterus, Myomectomy, Abdominal myomectomy