Surgery, Hand
Conditions
Brief summary
The purpose of this study is to determine whether the addition of dexamethasone prolongs analgesia when added to long-acting local anesthetic during single-injection supraclavicular block for outpatient hand surgery.
Detailed description
The goal for pain control after surgery is to provide the best possible pain control for the longest period of time with the least amount of side effects. One type of pain medication is called local anesthetic, which is a numbing medication that is injected in the area surrounding nerves to block pain. This injection is called a nerve block. Ropivacaine is a local anesthetic that is commonly used for nerve blocks and will be used in this study. The effects of ropivacaine may last for 8 to 12 hours after surgery. Recent research studies have shown that adding a medication called dexamethasone (a steroid) may increase the time that the nerve block will provide pain control. The purpose of this study is to see if adding dexamethasone to ropivacaine and injecting this around the nerves during a supraclavicular brachial plexus block increases the duration of pain relief as compared to both placebo control and systemic control groups.
Interventions
DRUGRopivacaine
DRUGDexamethasone
OTHERPlacebo
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age and older * Patients scheduled for elective outpatient hand surgery with same day discharge at the Duke Ambulatory Surgery Center
Exclusion criteria
* Patients who refuse regional anesthesia * Patients in whom peripheral nerve block is contraindicated * Patients unable to sign/understand consent * Patients with significant language barriers who cannot comply with data collection process * Patients with known allergies to local anesthetics * Pregnancy * Chronic pain patients or patients requiring chronic opioid treatment * Patients with a history of diabetes * Patients with contraindication to steroid administration (allergy, chronic steroid use)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to First Analgesic Dose | 48 hours |
Participant flow
Recruitment details
Because the required sample size of 60 subjects was not met, the study was terminated. Five subjects were enrolled from April 2012 to September 2013.
Participants by arm
| Arm | Count |
|---|---|
| Intravenous (IV) Control Group This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.
Ropivacaine + Dexamethasone | 2 |
| Local Anesthetic (LA) Control Group This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.
Ropivacaine + Placebo | 2 |
| Additive Group This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
Ropivacaine + Dexamethasone + Placebo | 1 |
| Total | 5 |
Baseline characteristics
| Characteristic | Total | Intravenous (IV) Control Group | Local Anesthetic (LA) Control Group | Additive Group |
|---|---|---|---|---|
| Age, Customized <=17 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized >= 18 years | 5 participants | 2 participants | 2 participants | 1 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 1 |
Outcome results
Primary
Time to First Analgesic Dose
Time frame: 48 hours
Population: one subject in the Local Anesthetic (LA) Control Group was not analyzed because subject did not return the data sheet
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthetic (LA) Control Group | Time to First Analgesic Dose | 10 hours | Standard Deviation 0 |
| Intravenous (IV) Control Group | Time to First Analgesic Dose | 6 hours | Standard Deviation 0 |
| Additive Group | Time to First Analgesic Dose | 4 hours | Standard Deviation 0 |