Cool Pre-operative TAP Blocks

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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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

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Anesthetics, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cool Block

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

Group Type EXPERIMENTAL

Cool Ropivacaine Block

Intervention Type DRUG

Ropivacaine is cooled.

Room Temp Block

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

Group Type ACTIVE_COMPARATOR

Room Temp Ropivacaine Block

Intervention Type DRUG

Room Temp Block

Interventions

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Cool Ropivacaine Block

Ropivacaine is cooled.

Intervention Type DRUG

Room Temp Ropivacaine Block

Room Temp Block

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No