TOTEM: Trial of TAP Block Effective Medications

NCT ID: NCT04382859

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TAP block with liposomal bupivacaine

Active comparator

Group Type ACTIVE_COMPARATOR

Transversus abdominis plane (TAP) block with liposomal bupivacaine

Intervention Type PROCEDURE

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).

TAP block with 0.25% bupivacaine

Standard comparator

Group Type OTHER

Transversus abdominis plane (TAP) block with liposomal bupivacaine

Intervention Type PROCEDURE

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).

Interventions

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Transversus abdominis plane (TAP) block with liposomal bupivacaine

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).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women undergoing non robotic assisted laparoscopic surgery for benign gynecologic conditions
* English speaking

Exclusion Criteria

* Known current malignancy
* Contraindication to medications
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Western Michigan University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Melinda Abernethy

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melinda Abernethy, MD

Role: PRINCIPAL_INVESTIGATOR

Western Michigan University Homer Stryker M.D. School of Medicine

Locations

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Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Melinda Abernethy, MD

Role: CONTACT

Phone: (919) 260-9328

Email: [email protected]

Facility Contacts

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Melinda Abernethy, MD

Role: primary

Other Identifiers

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WMed-2020-0601

Identifier Type: -

Identifier Source: org_study_id