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TOTEM: Trial of TAP Block Effective Medications

W

Western Michigan University School of Medicine

Status

Unknown

Conditions

Pain, Postoperative

Treatments

Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT04382859
WMed-2020-0601

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Known current malignancy
  • Contraindication to medications

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

56 participants in 2 patient groups

TAP block with liposomal bupivacaine
Active Comparator group
Description:
Active comparator
Treatment:
Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine
TAP block with 0.25% bupivacaine
Other group
Description:
Standard comparator
Treatment:
Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine

Trial contacts and locations

1

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Central trial contact

Melinda Abernethy, MD

Data sourced from clinicaltrials.gov

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