Block Additive, Regional Block for Pain Control, Supraclavicular Block, Ultrasound Guided Block
Conditions
Keywords
nerve block, outpatient surgery
Brief 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. The goal will be to see if the additive extends the life of the pain control portion of the ultrasound guided supraclavicular nerve block.
Interventions
DRUGBuprenorphine
added to nerve block, 0.3mg one time peripheral block use
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesiologists (ASA) physical status 1-3 2. Age 18-79, inclusive 3. BMI \<36 kg/m\^2 4. Patient consenting to single injection brachial plexus nerve block as primary anesthetic for a procedure
Exclusion criteria
1. Patients with coagulation disorders 2. Clinically significant pulmonary disease 3. Clinically significant cardiac disease 4. Neurologic deficit in surgical extremity 5. Allergy to bupivacaine or buprenorphine 6. Intolerance of narcotics 7. Local infection over intended area of needle insertion 8. Hepatic failure or renal failure 9. Significant psychiatric disease, including drug abuse 10. Seizure disorder 11. Possible pregnancy or lactation by patient report 12. Use of narcotic medication greater than 2 times a week for greater than 1 week. 13. Patients for whom the surgeon requests a shorter-acting block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Until First Pain Medication Post-operatively | 48 hrs | Time in minutes until first pain medication was take by participant post-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score on Post Operative Day 1 | 1 day postoperative | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group will get only local anesthetic and epinephrine in block. no additive in block | 14 |
| Buprenorphine will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block
Buprenorphine: added to nerve block, 0.3mg one time peripheral block use | 12 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Screen failure | 1 | 2 |
Baseline characteristics
| Characteristic | Control Group | Buprenorphine | Total |
|---|---|---|---|
| Age, Customized Age of participants 20-29 | 3 Participants | 3 Participants | 6 Participants |
| Age, Customized Age of participants 30-39 | 0 Participants | 2 Participants | 2 Participants |
| Age, Customized Age of participants 40-49 | 4 Participants | 1 Participants | 5 Participants |
| Age, Customized Age of participants 50-59 | 3 Participants | 3 Participants | 6 Participants |
| Age, Customized Age of participants 60-69 | 3 Participants | 2 Participants | 5 Participants |
| Age, Customized Age of participants 70-79 | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 11 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Time Until First Pain Medication Post-operatively
Time in minutes until first pain medication was take by participant post-operatively
Time frame: 48 hrs
Population: The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment.The Overall Number of Participants Analyzed represents the Number of Participants with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Time Until First Pain Medication Post-operatively | 965 Time in minutes | Standard Deviation 250 |
| Buprenorphine | Time Until First Pain Medication Post-operatively | 862 Time in minutes | Standard Deviation 311 |
Secondary
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)
Time frame: 1 day postoperative
Population: The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Pain Score on Post Operative Day 1 | 6.5 score on a scale |
| Buprenorphine | Pain Score on Post Operative Day 1 | 4.5 score on a scale |