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Cool Pre-operative TAP Blocks

Pilot Study on the Thermal Effects of Local Anesthetics

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04761887
Enrollment
0
Registered
2021-02-21
Start date
2022-12-31
Completion date
2023-03-31
Last updated
2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetics, Local

Keywords

ropivacaine

Brief 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.

Interventions

DRUGCool Ropivacaine Block

Ropivacaine is cooled.

DRUGRoom Temp Ropivacaine Block

Room Temp Block

Sponsors

Daniel Wambold
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Time to block of pain and thermosensory perception35 minutes

Secondary

MeasureTime frame
Morphine equivalency units of adjunct pain medications24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026