Cool Pre-operative TAP Blocks

Pilot Study on the Thermal Effects of Local Anesthetics

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.

Study Overview

• Status: Withdrawn
• Conditions: Anesthetics, Local
• Intervention / Treatment: Drug: Cool Ropivacaine Block; Drug: Room Temp Ropivacaine Block

Detailed Description

After consenting, subjects will be randomized to receive either cooled ropivacaine, administered at approximately 4°C) or room temperature ropivacaine, administered at approximately 20-25°C), during an ultrasound-guided TAP block. Time to anesthesia, or loss of sensation, will be recorded for each subject by a single evaluator, employing the pinch technique and thermosensory perception, using a glove, filled with a slurry of ice water placed on both anesthetized and non-anesthetized areas, for approximately 5 seconds. Time to anesthesia will be recorded when there is a definitive difference on a categorical scale (painful/not painful or cold/not cold) as measured by the subject, between the anesthetized and non-anesthetized areas. Safety outcomes and opioid morphine equivalency will be recorded for all subjects, for approximately 48 hours following surgery.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cool Block; Ropivacaine administered at approximately 4C, via a TAP block.	Drug: Cool Ropivacaine Block; Ropivacaine is cooled.
ACTIVE_COMPARATOR: Room Temp Block; Ropivacaine administered at approximately 20-25C, via a TAP block.	Drug: Room Temp Ropivacaine Block; Room Temp Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to block of pain and thermosensory perception	35 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Morphine equivalency units of adjunct pain medications	24 hours

Collaborators and Investigators

• Sponsor: Daniel Wambold
• Investigators: Principal Investigator: Daniel Wambold, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (ACTUAL): February 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: ropivacaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 57733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No