Post Surgical Pain
Conditions
Brief summary
When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic shoulder surgery. This study seeks to determine if there is a relationship between the duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP) when combined with increasing doses of dexamethasone.
Detailed description
The exact mechanism of dexamethasone on peripheral nerve block is unclear. The current theory is that the effect is not dose related, while only 4mg and 8mg doses were studied. Our hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect on the duration of analgesia. Therefore, we are not considering any patients to receive suboptimal dosing of preservative free dexamethasone in this study.
Interventions
DRUGBupivacaine 0.25%
DRUGDexamethasone
DRUGnormal saline
placebo
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 to 70 scheduled for primary shoulder arthroscopy who have already elected to receive and are eligible for regional anesthesia (brachial plexus nerve block) prior to consenting for study. 2. Ability to sign informed consent. 3. Ability to follow study protocol, and speak, read and write in English. 4. Must have valid phone number for follow-up purpose. 5. Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet.
Exclusion criteria
1. Patient younger than 18 years old and older than age 70 2. Patient refusal to sign consent 3. Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record 4. Allergy to any of the protocol medications 5. Patients with severe lung disease, contra lateral phrenic nerve injury, insulin-dependent diabetes, hepatic disease/failure, kidney disease/failure as documented in patient's medical record 6. Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Variable is Post Operative Sensory Block Duration | days 1, 2, and day 7 | This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Secondary Outcome Variable is Post Operative Motor Block Duration | days 1, 2, and day 7 | This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine 0.25% Mixed With 1ml Normal Saline Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25%
normal saline: placebo | 23 |
| Bupivacaine 0.25% With 1mg Dexamethasone (1ml) Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone | 20 |
| Bupivacaine 0.25% Mixed With 2mg Dexamethasone Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone | 22 |
| Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25%
Dexamethasone | 24 |
| Total | 89 |
Baseline characteristics
| Characteristic | Bupivacaine 0.25% Mixed With 1ml Normal Saline | Bupivacaine 0.25% With 1mg Dexamethasone (1ml) | Bupivacaine 0.25% Mixed With 2mg Dexamethasone | Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 20 Participants | 22 Participants | 24 Participants | 89 Participants |
| Age, Continuous | 47.1 years STANDARD_DEVIATION 11.3 | 46.2 years STANDARD_DEVIATION 11.8 | 48.8 years STANDARD_DEVIATION 14.1 | 53.0 years STANDARD_DEVIATION 12.5 | 48.4 years STANDARD_DEVIATION 12.4 |
| BMI | 30.4 kg/m2 STANDARD_DEVIATION 6.6 | 29.4 kg/m2 STANDARD_DEVIATION 4 | 28.9 kg/m2 STANDARD_DEVIATION 4.4 | 31.0 kg/m2 STANDARD_DEVIATION 6.3 | 30.3 kg/m2 STANDARD_DEVIATION 5.7 |
| Region of Enrollment United States | 23 participants | 20 participants | 22 participants | 24 participants | 89 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 6 Participants | 5 Participants | 22 Participants |
| Sex: Female, Male Male | 18 Participants | 14 Participants | 16 Participants | 19 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 20 | 0 / 22 | 0 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 20 | 0 / 22 | 0 / 24 |
Outcome results
Primary
Primary Outcome Variable is Post Operative Sensory Block Duration
This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.
Time frame: days 1, 2, and day 7
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivacaine 0.25% Mixed With 1ml Normal Saline | Primary Outcome Variable is Post Operative Sensory Block Duration | 12.1 hours |
| Bupivacaine 0.25% With 1mg Dexamethasone (1ml) | Primary Outcome Variable is Post Operative Sensory Block Duration | 22.3 hours |
| Bupivacaine 0.25% Mixed With 2mg Dexamethasone | Primary Outcome Variable is Post Operative Sensory Block Duration | 23.3 hours |
| Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml | Primary Outcome Variable is Post Operative Sensory Block Duration | 21.2 hours |
Secondary
The Secondary Outcome Variable is Post Operative Motor Block Duration
This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.
Time frame: days 1, 2, and day 7
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivacaine 0.25% Mixed With 1ml Normal Saline | The Secondary Outcome Variable is Post Operative Motor Block Duration | 12.1 hours |
| Bupivacaine 0.25% With 1mg Dexamethasone (1ml) | The Secondary Outcome Variable is Post Operative Motor Block Duration | 21 hours |
| Bupivacaine 0.25% Mixed With 2mg Dexamethasone | The Secondary Outcome Variable is Post Operative Motor Block Duration | 20.9 hours |
| Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml | The Secondary Outcome Variable is Post Operative Motor Block Duration | 19.4 hours |