NCT04761887

Cool Pre-operative TAP Blocks

Pilot Study on the Thermal Effects of Local Anesthetics

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Daniel Wambold · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anesthetics, Local

Interventions

Type	Name	Description
DRUG	Cool Ropivacaine Block	Ropivacaine is cooled.
DRUG	Room Temp Ropivacaine Block	Room Temp Block

Timeline

• Start date: 2022-12-01
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2021-02-21
• Last updated: 2022-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study