Anesthetics, LocalPhase 1NCT04761887
Cool Pre-operative TAP Blocks
A Phase 1 study testing Cool Ropivacaine Block and Room Temp Ropivacaine Block in people with Anesthetics, Local, run by Daniel Wambold at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthetics, Local
- What is being tested?
- Cool Ropivacaine Block and Room Temp Ropivacaine Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2022to Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, aged =18 years of age.
- Patients, scheduled for surgery, with an order for a TAP block.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Thermal Effects of Local Anesthetics
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.
Read the 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
- Being tested
- Cool Ropivacaine Block, Room Temp Ropivacaine Block
- Keywords
- ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cool Ropivacaine BlockDrug
Ropivacaine is cooled.
Room Temp Ropivacaine BlockDrug
Room Temp Block
| Study group | Role | What they receive |
|---|---|---|
| Cool Block | Experimental | Ropivacaine administered at approximately 4C, via a TAP block. Receives: Drug: Cool Ropivacaine Block |
| Room Temp Block | Active comparator | Ropivacaine administered at approximately 20-25C, via a TAP block. Receives: Drug: Room Temp Ropivacaine Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to block of pain and thermosensory perception
Measured: 35 minutes
Secondary outcomes (1)
Morphine equivalency units of adjunct pain medications
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study startDec 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: Study withdrawn prior to enrollment (insufficient funds and reduced access to patients related to COVID protocols)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetics, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Wambold
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Wambold, University of Kentucky
- Investigators
- Daniel Wambold, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761887
- Sponsor's protocol ID
- 57733
- Status last verified
- Oct 2022
- First submitted
- 16 Feb 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Thermal Effects of Local Anesthetics
- ClinicalTrials.gov ID
- NCT04761887
- Acronym / sponsor ID
- 57733
- Conditions
- Anesthetics, Local
- Keywords
- ropivacaine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn prior to enrollment (insufficient funds and reduced access to patients related to COVID protocols)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daniel WamboldUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cool Block | Experimental | Drug: Cool Ropivacaine BlockRopivacaine administered at approximately 4C, via a TAP block. |
| Room Temp Block | Active comparator | Drug: Room Temp Ropivacaine BlockRopivacaine administered at approximately 20-25C, via a TAP block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients, aged =18 years of age.
- Patients, scheduled for surgery, with an order for a TAP block.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cool Ropivacaine BlockRopivacaine is cooled. | Drug | Cool Block |
| Room Temp Ropivacaine BlockRoom Temp Block | Drug | Room Temp Block |
Primary outcome
Time to block of pain and thermosensory perception
Time frame: 35 minutes
1 secondary outcome
Morphine equivalency units of adjunct pain medications
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Wambold, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cool Ropivacaine Block and Room Temp Ropivacaine Block in people with Anesthetics, Local, run by Daniel Wambold at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to block of pain and thermosensory perception (time frame: 35 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.