Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy

Mixture of Liposomal Bupivicaine and Bupivicaine Hydrogen Chloride (HCl) May Provide Faster and Longer Lasting Analgesia in Transversus Abdominis Block for Patient Having Open Abdominal Hysterectomies

The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.

Study Overview

• Status: Completed
• Conditions: Hysterectomy
• Intervention / Treatment: Drug: Bupivacaine; Drug: Liposomal bupivacaine; Drug: Saline

Detailed Description

All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Elective open abdominal hysterectomy with midline incision, age > 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.

Exclusion Criteria:

• Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine; Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine	Drug: Bupivacaine; 0.25% bupivacaine for TAP block; Other Names: Marcaine, Sensorcaine
Active Comparator: Liposomal bupivacaine; Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. this group will not receive bupivacaine. they receive only liposomal bupivacaine.	Drug: Liposomal bupivacaine; Exparel for TAP block; Other Names: Exparel; Drug: Saline; Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
Experimental: Liposomal bupivacaine and bupivacaine; Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. this group will receive the mixture of Liposomal bupivacaine and bupivacaine.	Drug: Bupivacaine; 0.25% bupivacaine for TAP block; Other Names: Marcaine, Sensorcaine; Drug: Liposomal bupivacaine; Exparel for TAP block; Other Names: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)	Total opioid consumption	0 - 72 hours post-operatively
Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given	time to first opioid given	0 - 72 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied	Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.	0 - 72 hours post-operatively
Length of Stay in the Hospital	Length of stay in the hospital, maximum time until discharge from the hospital	until the patient is discharged from the hospital
Number of Patients With Local Anesthetic Toxicity	Presence of local anesthetic toxicity	0 - 72 hours post-operatively
Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure	Presence of hemodynamic instability	0 - 72 hours post-operatively
Pain Scores Using Visual Analogue Scale ( 0-10)	Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.	0-24 postoperative pain scores

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Mohamed-Rida Alsaden, MBChB FRCPC, Henry Ford Hospital

Publications and helpful links

General Publications

• Fidkowski CW, Choksi N, Alsaden MR. A randomized-controlled trial comparing liposomal bupivacaine, plain bupivacaine, and the mixture of liposomal bupivacaine and plain bupivacaine in transversus abdominus plane block for postoperative analgesia for open abdominal hysterectomies. Can J Anaesth. 2021 Jun;68(6):773-781. doi: 10.1007/s12630-020-01911-1. Epub 2021 Jan 11.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: TAP block; Liposomal bupivicaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB 10655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual patient data will be available to only study researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No