Cool Pre-operative TAP Blocks

Anesthetics, Local Clinical Trial

Official title:

Pilot Study on the Thermal Effects of Local Anesthetics

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04761887
• Other study ID #: 57733
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 2022
• Est. completion date: March 2023

Study information

• Verified date: October 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthetics, Local

Intervention

Drug:
• Cool Ropivacaine Block
Ropivacaine is cooled.
• Room Temp Ropivacaine Block
Room Temp Block

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Wambold

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to block of pain and thermosensory perception		35 minutes
Secondary	Morphine equivalency units of adjunct pain medications		24 hours