Pain, Shoulder Arthroscopy
Conditions
Brief summary
Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The addition of higher doses of dexamethasone to nerve blocks, which are injections of local anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce pain. However, it is unclear whether the advantage of longer pain relief outweighs patient dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have shown that systemic, intravenously administered dexamethasone may similarly reduce pain levels when compared with dexamethasone in the block. In our study, the investigators propose to examine the effect of low-dose IV versus block dexamethasone on interscalene block duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more. One study suggests that 1 mg may have the same effect as larger doses. Our aims are to determine whether the addition of low-dose dexamethasone to a local anesthetic in the block can prolong its duration, and whether there are differences in postoperative pain, consumption of painkillers, side effects, and satisfaction in patients who received IV or block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and 7-10 days after surgery. Results from this study will reveal whether patients prefer the longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.
Interventions
DRUGBupivacaine
Dexamethasone in nerve block
DRUGPerineural saline
Saline in nerve block
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients having ambulatory arthroscopic shoulder surgery under ultrasound-guided interscalene block (rotator cuffs, acromioplasties, stabilizations, labral repairs, etc.) * Age 18-70 years
Exclusion criteria
* Contraindication to interscalene block * Known allergy/sensitivity to any study medications * Having taken daily steroids for 10 days or longer anytime during the past year * Body mass index \<18 or \>40 * History of uncontrolled nausea and vomiting with opioids or severe post-op nausea and vomiting (to prevent any need for higher doses of IV dexamethasone) * Non-English speaking * Revision procedures * Additional procedures (e.g., removal of hardware, procedures involving other areas, etc.) * Planned open procedures * History of diabetes * Arthroscopic irrigation and debridement secondary to infection * Peripheral neuropathies affecting the operative extremity * Having taken opiates daily for 10 days or longer immediately preceding surgery, 3 times a week for greater than 3 months anytime in the past year, or currently taking for anything other than shoulder pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nerve Block Duration | Postoperative day 2+ | Time at which the pain relief from the block has completely worn off |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | Postoperative day 2, postoperative day 3 | — |
| Side Effects | Postoperative day 2, postoperative day 3 | Opioid-related symptom distress scale is calculated using responses to the symptom severity questions only. For each symptom, severity is assessed by the question: (If yes), how severe was it usually? (In the past 24 hours) The responses to the severity questions are measured on a 5-point scale from 0-4 in ascending order as follows: Did not have symptom (0) Slight (1) Moderate (2) Severe (3) Very severe (4) |
| Numerical Rating Scale Pain Scores | Duration of stay in recovery room after surgery (average of 3 hours) | The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) |
| Block-related Complications | Postoperative day 7-10 | — |
| % of Participants Who Guessed the Correct Group | Postoperative day 7-10 | Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group |
| Block Satisfaction | Postoperative day 2, postoperative day 3 | 0-10 scale (0=not satisfied; 10=extremely satisfied) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Dexamethasone Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Bupivacaine
Intravenous dexamethasone
Perineural saline: Saline in nerve block | 62 |
| Perineural Dexamethasone Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Bupivacaine
Perineural dexamethasone: Dexamethasone in nerve block
Intravenous saline | 63 |
| Total | 125 |
Baseline characteristics
| Characteristic | Intravenous Dexamethasone | Perineural Dexamethasone | Total |
|---|---|---|---|
| Age, Continuous | 46.7 years STANDARD_DEVIATION 14.6 | 49.9 years STANDARD_DEVIATION 13.6 | 48.3 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 57 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 23 Participants | 26 Participants | 49 Participants |
| Sex: Female, Male Male | 39 Participants | 37 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 62 | 0 / 63 |
| serious Total, serious adverse events | 0 / 62 | 0 / 63 |
Outcome results
Primary
Nerve Block Duration
Time at which the pain relief from the block has completely worn off
Time frame: Postoperative day 2+
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Dexamethasone | Nerve Block Duration | 22.2 Hours |
| Perineural Dexamethasone | Nerve Block Duration | 25.7 Hours |
Secondary
Block-related Complications
Time frame: Postoperative day 7-10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Dexamethasone | Block-related Complications | 0 patients with block complications |
| Perineural Dexamethasone | Block-related Complications | 0 patients with block complications |
Secondary
Block Satisfaction
0-10 scale (0=not satisfied; 10=extremely satisfied)
Time frame: Postoperative day 2, postoperative day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intravenous Dexamethasone | Block Satisfaction | postoperative day 2 | 8.1 units on a scale | Standard Deviation 2.2 |
| Intravenous Dexamethasone | Block Satisfaction | postoperative day 3 | 8.0 units on a scale | Standard Deviation 2.1 |
| Perineural Dexamethasone | Block Satisfaction | postoperative day 2 | 8.1 units on a scale | Standard Deviation 2.2 |
| Perineural Dexamethasone | Block Satisfaction | postoperative day 3 | 7.5 units on a scale | Standard Deviation 2.5 |
Secondary
Numerical Rating Scale Pain Scores
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable)
Time frame: Duration of stay in recovery room after surgery (average of 3 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Dexamethasone | Numerical Rating Scale Pain Scores | 0 Units on a Scale |
| Perineural Dexamethasone | Numerical Rating Scale Pain Scores | 0 Units on a Scale |
Secondary
% of Participants Who Guessed the Correct Group
Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group
Time frame: Postoperative day 7-10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Dexamethasone | % of Participants Who Guessed the Correct Group | -7 % of participants |
| Perineural Dexamethasone | % of Participants Who Guessed the Correct Group | 3.4 % of participants |
Secondary
Opioid Consumption
Time frame: Postoperative day 2, postoperative day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intravenous Dexamethasone | Opioid Consumption | Postoperative day 2 | 67.3 mg | Standard Deviation 55.7 |
| Intravenous Dexamethasone | Opioid Consumption | postoperative day 3 | 33 mg | Standard Deviation 48.6 |
| Perineural Dexamethasone | Opioid Consumption | Postoperative day 2 | 67.4 mg | Standard Deviation 51 |
| Perineural Dexamethasone | Opioid Consumption | postoperative day 3 | 39.7 mg | Standard Deviation 55.3 |
Secondary
Side Effects
Opioid-related symptom distress scale is calculated using responses to the symptom severity questions only. For each symptom, severity is assessed by the question: (If yes), how severe was it usually? (In the past 24 hours) The responses to the severity questions are measured on a 5-point scale from 0-4 in ascending order as follows: Did not have symptom (0) Slight (1) Moderate (2) Severe (3) Very severe (4)
Time frame: Postoperative day 2, postoperative day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intravenous Dexamethasone | Side Effects | Postoperative day 2 | 0.5 units on a scale | Standard Deviation 0.5 |
| Intravenous Dexamethasone | Side Effects | postoperative day 3 | 0.4 units on a scale | Standard Deviation 0.4 |
| Perineural Dexamethasone | Side Effects | Postoperative day 2 | 0.6 units on a scale | Standard Deviation 0.5 |
| Perineural Dexamethasone | Side Effects | postoperative day 3 | 0.4 units on a scale | Standard Deviation 0.4 |