TOTEM: Trial of TAP Block Effective Medications

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04382859

Acronym

TOTEM

Enrollment

Registered

2020-05-11

Start date

2020-12-01

Completion date

2021-02-28

Last updated

2020-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Brief summary

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.

Interventions

PROCEDURETransversus 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Known current malignancy * Contraindication to medications

Design outcomes

Primary

Measure	Time frame	Description
Pain rating 1 hour post operation	1 hour post operation	Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Pain rating 2 hours post operation	2 hours post operation	Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Pain rating 4 hours post operation	4 hours post operation	Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Pain rating 72 hours post operation	72 hours post operation	Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain

Countries

United States

Contacts

Primary ContactMelinda Abernethy, MD

melinda.abernethy@med.wmich.edu(919) 260-9328

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026