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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04761887
Status
Withdrawn
Sponsor
Daniel Wambold

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.