Local Anesthetic
Conditions
Keywords
surgery for arm hand or elbow, mepivacaine, ropivacaine, hand surgery, elbow surgery, forearm surgery
Brief summary
This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics.
Detailed description
Patients will be randomized into one of two groups, Group M: Ropivacaine and Mepivacaine - subject will receive two injections before surgery begins. These two injections will consist of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml). Group S: Mepivacaine followed by Ropivacaine. Subjects will receive two injections before surgery begins. One injection will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml). On the first, second, and third mornings after surgery,subjects will be asked to rate their pain on a scale of 1 to 10. If the subject is discharged from the hospital, a telephone call will be made to the subject's home to collect this information.
Interventions
DRUGMepivacaine
One syringe will contain mepivacaine (15 ml)
DRUGRopivacaine
ropivacaine (15 ml).
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing upper extremity procedures suitable for supraclavicular anesthesia, including but not limited to oHand surgery oForearm surgery oElbow surgery * Age between 18 and 70 years
Exclusion criteria
* Contraindications to supraclavicular block * Coagulopathy * Infection at the needle insertion site * Severe chronic obstructive pulmonary disease (COPD) * Contralateral pneumothorax or diaphragmatic paralysis * Pregnancy * Preexisting neuropathy involving the surgical limb * Routine opioid use * Inability to attain adequate ultrasound images in the supraclavicular area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Analgesia. | During surgery: postoperative day 0 | The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Onset of First Sensory Block | during surgery | — |
| Maximum Verbal Response Score (VRS) With Rest | through post operative day 3 | The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain |
| Time to Complete Motor Block | during surgery from induction time to end case time | — |
| Duration of Analgesia | from surgery date to postoperative day 1 | Time from the complete onset of sensory block until first request for an analgesic |
| Total Opioid Consumption | postoperative day 1 to day 3 | In morphine equivalent dose |
| Maximum Verbal Response Score (VRS) With Movement | through post operative day 3 | The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml) | 52 |
| Group 2 sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml) | 51 |
| Total | 103 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 13 | 46 years STANDARD_DEVIATION 14 | 47 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 25 Participants | 32 Participants | 57 Participants |
| Sex: Female, Male Male | 27 Participants | 19 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 51 |
| other Total, other adverse events | 0 / 52 | 0 / 51 |
| serious Total, serious adverse events | 0 / 52 | 0 / 51 |
Outcome results
Primary
Duration of Analgesia.
The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.
Time frame: During surgery: postoperative day 0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Duration of Analgesia. | 7.5 minute |
| Group 2 | Duration of Analgesia. | 10 minute |
p-value: 0.1495% CI: [0.46, 1.09]Log Rank
Secondary
Duration of Analgesia
Time from the complete onset of sensory block until first request for an analgesic
Time frame: from surgery date to postoperative day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Duration of Analgesia | 9 hours |
| Group 2 | Duration of Analgesia | 11 hours |
p-value: 0.15Log Rank
Secondary
Maximum Verbal Response Score (VRS) With Movement
The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst
Time frame: through post operative day 3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Maximum Verbal Response Score (VRS) With Movement | 5.5 mm |
| Group 2 | Maximum Verbal Response Score (VRS) With Movement | 5 mm |
p-value: 0.34ANCOVA
Secondary
Maximum Verbal Response Score (VRS) With Rest
The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain
Time frame: through post operative day 3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Maximum Verbal Response Score (VRS) With Rest | 4 mm |
| Group 2 | Maximum Verbal Response Score (VRS) With Rest | 4 mm |
p-value: 0.6ANCOVA
Secondary
Time to Complete Motor Block
Time frame: during surgery from induction time to end case time
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Time to Complete Motor Block | 10 minutes |
| Group 2 | Time to Complete Motor Block | 19 minutes |
p-value: 0.02Log Rank
Secondary
Time to Onset of First Sensory Block
Time frame: during surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Time to Onset of First Sensory Block | 0 minutes |
| Group 2 | Time to Onset of First Sensory Block | 0 minutes |
p-value: 0.66Log Rank
Secondary
Total Opioid Consumption
In morphine equivalent dose
Time frame: postoperative day 1 to day 3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Total Opioid Consumption | 38 mg |
| Group 2 | Total Opioid Consumption | 30 mg |
p-value: 0.88ANCOVA