Regional Block for Pain ControlNCT01583179
Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution
A study testing Buprenorphine in people with Regional Block for Pain Control and Supraclavicular Block, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The patients included will be those who have already agreed to have a brachial plexus nerve block for surgery. A flip of the coin will decide who gets and additive called buprenorphine in their block or not. They will both contain the same amount and type of numbing medicine. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Regional Block for Pain Control, Supraclavicular Block, Ultrasound Guided Block
- What is being tested?
- Buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1-3
- Age 18-79, inclusive
- BMI <36 kg/m^2
- Patient consenting to single injection brachial plexus nerve block as primary anesthetic for a procedure
Who cannot join
- Patients with coagulation disorders
- Clinically significant pulmonary disease
- Clinically significant cardiac disease
- Neurologic deficit in surgical extremity
- Allergy to bupivacaine or buprenorphine
- Intolerance of narcotics
Show all 13Show fewer
- Local infection over intended area of needle insertion
- Hepatic failure or renal failure
- Significant psychiatric disease, including drug abuse
- Seizure disorder
- Possible pregnancy or lactation by patient report
- Use of narcotic medication greater than 2 times a week for greater than 1 week.
- Patients for whom the surgeon requests a shorter-acting block
Trial locations and contacts
1 site in 1 country.
About this study
The patients included will be those who have already agreed to have a brachial plexus nerve block for surgery. A flip of the coin will decide who gets and additive called buprenorphine in their block or not. They will both contain the same amount and type of numbing medicine. The goal will be to see if the additive extends the life of the pain control portion of the ultrasound guided supraclavicular nerve block.
- Conditions
- Regional Block for Pain Control, Supraclavicular Block, Ultrasound Guided Block, Block Additive
- Being tested
- Buprenorphine
- Keywords
- nerve block, outpatient surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
added to nerve block, 0.3mg one time peripheral block use
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | will get only local anesthetic and epinephrine in block. no additive in block |
| buprenorphine | Experimental | will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Until First Pain Medication Post-operatively
Time in minutes until first pain medication was take by participant post-operatively
Measured: 48 hrs
Secondary outcomes (1)
Pain Score on Post Operative Day 1
pain score on post operative day 1 was measured on a scale 1-10. higher scores correlates with more severe pain. score range is from '0' (no pain) to 10 (pain as severe as it can be)
Measured: 1 day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completionDec 2015
Why it stopped: The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Regional Block for Pain ControlStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Donnelly, MD, Principal investigator, University of Wisconsin School of Medicine and Public Health, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583179
- Sponsor's protocol ID
- 2011-0781
- Other IDs
- SMPH/ANESTHESIO, A530900
- Status last verified
- Sep 2019
- First submitted
- 19 Apr 2012
- Last updated
- 11 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution
- ClinicalTrials.gov ID
- NCT01583179
- Acronym / sponsor ID
- 2011-0781
- Conditions
- Regional Block for Pain Control, Supraclavicular Block, Ultrasound Guided Block, Block Additive
- Keywords
- nerve block, outpatient surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Apr 2012 (estimated)
- Results
- Posted 11 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The patients included will be those who have already agreed to have a brachial plexus nerve block for surgery. A flip of the coin will decide who gets and additive called buprenorphine in their block or not. They will both contain the same amount and type of numbing medicine. The goal will be to see if the additive extends the life of the pain control portion of the ultrasound guided supraclavicular nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –will get only local anesthetic and epinephrine in block. no additive in block |
| buprenorphine | Experimental | Drug: Buprenorphinewill receive local anesthetic, epinephrine and the additive buprenorphine to nerve block |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status 1-3
- Age 18-79, inclusive
- BMI <36 kg/m^2
- Patient consenting to single injection brachial plexus nerve block as primary anesthetic for a procedure
Key exclusion criteria (13 listed)
- Patients with coagulation disorders
- Clinically significant pulmonary disease
- Clinically significant cardiac disease
- Neurologic deficit in surgical extremity
- Allergy to bupivacaine or buprenorphine
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 |
|---|---|---|
| Buprenorphineadded to nerve block, 0.3mg one time peripheral block use | Drug | buprenorphine |
Primary outcome
Time Until First Pain Medication Post-operatively
Time frame: 48 hrs
Time in minutes until first pain medication was take by participant post-operatively
1 secondary outcome
Pain Score on Post Operative Day 1
Time frame: 1 day postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Melanie Donnelly, MD principal investigator
University of Wisconsin School of Medicine and Public Health, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buprenorphine in people with Regional Block for Pain Control and Supraclavicular Block, run by University of Wisconsin, Madison 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 4 inclusion and 13 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: stopped early, as of the sponsor's last update on 11 Sep 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Until First Pain Medication Post-operatively (time frame: 48 hrs). 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 11 Sep 2019.