Cool Pre-operative TAP Blocks

NCT04761887 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 57733
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study of approximately 20 pre-operative patients scheduled for a transversus abdominis plane (TAP) block as pain management for a previously scheduled surgery. Subjects will be randomly assigned to receive either cooled ropivacaine (4°C) during a TAP block or room temperature (between 20-25°C) ropivacaine during the block. The effects of a TAP block generally diminish within 24 hours. We believe that cooling ropivacaine before administration may slightly prolong the analgesic effects of the block and delay time before additional analgesic is requested, resulting in less opioid use following surgery.

Conditions

Anesthetics, Local

Keywords

ropivacaine

Outcome Measures

Primary Outcomes (1)

• Time to block of pain and thermosensory perception

  35 minutes

Secondary Outcomes (1)

• Morphine equivalency units of adjunct pain medications

  24 hours

Study Arms (2)

Cool Block

EXPERIMENTAL

Ropivacaine administered at approximately 4C, via a TAP block.

Drug: Cool Ropivacaine Block

Room Temp Block

ACTIVE COMPARATOR

Ropivacaine administered at approximately 20-25C, via a TAP block.

Drug: Room Temp Ropivacaine Block

Interventions

Cool Ropivacaine Block DRUG

Ropivacaine is cooled.

Cool Block

Room Temp Ropivacaine Block DRUG

Room Temp Block

Room Temp Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, aged =18 years of age.
• Patients, scheduled for surgery, with an order for a TAP block.

You may not qualify if:

• Patients with a history of opioid use disorder.
• Patients, which are scheduled as the first case of the day.
• Patients with any history of paralysis/palsy.
• Patients with a history of sensitivity to local anesthetics, including ropivacaine.
• Patients, whose blocks are scheduled to be administered by a PGY-1 or PGY-2 resident.

Sponsors & Collaborators

• Daniel Wambold: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Study Officials

• Daniel Wambold, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: December 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)