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

NCT ID: NCT03250507

Last Updated: 2022-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-13

Study Completion Date

2019-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hysterectomy

Keywords

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TAP block Liposomal bupivicaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized to one of three study groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Bupivacaine

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

0.25% bupivacaine for TAP block

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.

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

Exparel for TAP block

Saline

Intervention Type 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 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.

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

0.25% bupivacaine for TAP block

Liposomal bupivacaine

Intervention Type DRUG

Exparel for TAP block

Interventions

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Bupivacaine

0.25% bupivacaine for TAP block

Intervention Type DRUG

Liposomal bupivacaine

Exparel for TAP block

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Other Intervention Names

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Marcaine, Sensorcaine Exparel

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Rida Alsaden

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed-Rida Alsaden, MBChB FRCPC

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33432496 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB 10655

Identifier Type: -

Identifier Source: org_study_id