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

NCT03250507 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB 10655
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hysterectomy

Keywords

TAP block; Liposomal bupivicaine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied

  0 - 72 hours post-operatively

• Length of Stay in the Hospital

  until the patient is discharged from the hospital

• Number of Patients With Local Anesthetic Toxicity

  0 - 72 hours post-operatively

• Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure

  0 - 72 hours post-operatively

• Pain Scores Using Visual Analogue Scale ( 0-10)

  0-24 postoperative pain scores

Study Arms (3)

Bupivacaine

ACTIVE COMPARATOR

Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine

Drug: Bupivacaine

Liposomal bupivacaine

ACTIVE COMPARATOR

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; Drug: Saline

Liposomal bupivacaine and bupivacaine

EXPERIMENTAL

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; Drug: Liposomal bupivacaine

Interventions

Bupivacaine DRUG

0.25% bupivacaine for TAP block

Also known as: Marcaine, Sensorcaine

Bupivacaine; Liposomal bupivacaine and bupivacaine

Liposomal bupivacaine DRUG

Exparel for TAP block

Also known as: Exparel

Liposomal bupivacaine; Liposomal bupivacaine and bupivacaine

Saline DRUG

Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.

Liposomal bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligible patients are undergoing open abdominal hysterectomy and therefore are female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• 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.

  PMID: 33432496 DERIVED

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Christina Fidkowski, MD
• Organization: Henry Ford Hospital

cfidkow1@hfhs.org

313-916-7648

Study Officials

• Mohamed-Rida Alsaden, MBChB FRCPC

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient, surgical team, nursing team, anesthesia team, and outcomes assessor will be blinded to the group assignment. The anesthetist performing the TAP block will not be blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: Patients will be randomized to one of three study groups.

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: August 15, 2017
• Study Start: March 13, 2017
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: December 21, 2022
• Results First Posted: December 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)