Cool Pre-operative TAP Blocks

Study Overview
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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.

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.

Official Title
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Pilot Study on the Thermal Effects of Local Anesthetics

Conditions
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Anesthetics, Local

Intervention / Treatment
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* Drug: Cool Ropivacaine Block
* Drug: Room Temp Ropivacaine Block


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cool Block<br>Ropivacaine administered at approximately 4C, via a TAP block. | Drug: Cool Ropivacaine Block<br>* Ropivacaine is cooled.<br>|
| Active Comparator: Room Temp Block<br>Ropivacaine administered at approximately 20-25C, via a TAP block. | Drug: Room Temp Ropivacaine Block<br>* Room Temp Block<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ropivacaine