Cool Pre-operative TAP Blocks

Sponsor

Daniel Wambold (Other)

Overall Status

Recruiting

CT.gov ID

NCT04761887

Collaborator

(none)

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthetics, Local	Drug: Cool Ropivacaine Block Drug: Room Temp Ropivacaine Block	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Pilot Study on the Thermal Effects of Local Anesthetics

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time to block of pain and thermosensory perception [35 minutes]

Secondary Outcome Measures

Morphine equivalency units of adjunct pain medications [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

Daniel Wambold

Investigators

Principal Investigator: Daniel Wambold, MD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daniel Wambold, Study Principal Investigator, University of Kentucky

ClinicalTrials.gov Identifier:

NCT04761887

Other Study ID Numbers:

57733

First Posted:

Feb 21, 2021

Last Update Posted:

Dec 9, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Daniel Wambold, Study Principal Investigator, University of Kentucky

ropivacaine

Additional relevant MeSH terms:

Ropivacaine

Study Results

No Results Posted as of Dec 9, 2021