Shoulder Surgery, Nerve Block
Conditions
Brief summary
A standard interscalene nerve block is performed with long acting local anesthetic (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block compared to ropivacaine alone for interscalene block with systemic dexamethasone. Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a nerve block.
Detailed description
Interscalene brachial plexus block (ISB) is regarded as the standard of care for analgesia after shoulder surgery providing superior analgesia and reducing opioid consumption. Shoulder surgery, previously requiring inpatient admission for pain control, is now commonly performed on an ambulatory basis facilitated by ISB analgesia. The effects of single injection ISB dissipate after several hours unmasking the moderate to severe pain of the surgical insult and require strong opioid analgesia. Efforts to prolong ISB duration by increasing local anaesthetic (LA) dose are limited by their pharmacodynamics and narrow therapeutic window. To address some of these issues faced with prolonging ISB analgesia the addition of perineural adjuvants to local anesthetic (eg. clonidine, dexmedetomidine), have been investigated in an attempt to prolong peripheral nerve block duration with limited success. However, the corticosteroid dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect \ 6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. There are several reasons that warrant a new randomized trial. Chiefly, all of the previous trials do not reflect modern regional anesthetic practice. These trials utilized peripheral nerve stimulation (PNS) and local anesthetic volumes of 30 to 40 ml. Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local anesthetic with volumes ranging from 5 to 10 ml with no difference in block efficacy or duration compared to larger volumes (≥20ml). An ideal solution would be a local anesthetic with adjuvant mixture that allowed administration of lower volumes but with prolonged analgesic duration. The use of low dose local anesthetic with dexamethasone could be one such solution. A trial that demonstrates enhanced block quality and duration associated with perineural dexamethasone added to low dose local anesthetic may allow us to achieve both prolonged duration of effect and reduced side effects due to unwanted local anesthetic spread. This would create further significant benefits for patients and further promote the use of low dose local anesthetic techniques to anesthesiologists who do not currently use this technique.
Interventions
Intravenous infusion of dexamethasone (4mg)
Perinerual administration of dexamethasone (4mg)
Sponsors
Study design
Eligibility
Inclusion criteria
1. Patients undergoing arthroscopic shoulder surgery at Sunnybrook Health Sciences Centre, Toronto Western Hospital and Women's College Hospital. 2. ASA functional status class I to III 3. Age 18 to 80 years 4. BMI ≤ 35 kg/m2
Exclusion criteria
1. Lack of patient consent 2. Allergy to dexamethasone or ropivacaine 3. BMI \> 35 kg/m2 4. Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus 5. Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume \< 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection 6. Pregnant or nursing females 7. Chronic opioid use defined as \> 30mg oral morphine or equivalent per day 8. Unable to take acetaminophen or celecoxib
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Sensory Block | 1 day postoperative | Defined as time from completion of block procedure to NRS for pain \> 0 (in hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Motor Block | 1 day postoperative | Defined as time from completion of block procedure to return to baseline motor function (in hours) |
| Post-operative Oxygen Saturation on Room Air | 1 hour postoperative | Pulse oximetry (in %) measured 1 hour after arrival in post-operative recovery room, scale 0-100, higher number is better |
| Opioid Consumption | 7 days postoperative | Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours, and 7 days |
| Numeric Rating Scale for Pain (NRS 0-10) | 7 days postoperative | Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better. |
| Time to First Opioid Consumption | 1 day postoperative | Defined as time from completion of block procedure to first consumption of opioid analgesic (in hours) |
| Number of Participants With Nerve Damage From Interscalene Block | 7 Days postoperative | Defined as persistent paresthesia, and sensory/motor block at 7 days |
| Infection | 7 Days postoperative | Number of participants with localized infection at nerve block site |
| Number of Participants With Postoperative Nausea and/or Vomiting | 7 days postoperative | Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively |
| Postoperative Serum Blood Glucose | 1 hour postoperative | Measured 1 hour after arrival to the post-operative recovery room |
Countries
Canada
Participant flow
Recruitment details
Recruitment setting: pre-operative anesthesia clinic 182 recruited because of time lag between recruitment and surgery
Participants by arm
| Arm | Count |
|---|---|
| Perineural Dexamethasone ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
Perineural dexamethasone: Perinerual administration of dexamethasone (4mg) | 92 |
| Systemic Dexamethasone ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
Systemic Dexamethasone: Intravenous infusion of dexamethasone (4mg) | 90 |
| Total | 182 |
Baseline characteristics
| Characteristic | Perineural Dexamethasone | Systemic Dexamethasone | Total |
|---|---|---|---|
| Age, Continuous | 51.6 years | 52.8 years | 52.2 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 21 Participants | 46 Participants |
| Sex: Female, Male Male | 67 Participants | 69 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 90 |
| other Total, other adverse events | 0 / 92 | 0 / 90 |
| serious Total, serious adverse events | 0 / 92 | 0 / 90 |
Outcome results
Duration of Sensory Block
Defined as time from completion of block procedure to NRS for pain \> 0 (in hours)
Time frame: 1 day postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perineural Dexamethasone | Duration of Sensory Block | 521 minutes | Standard Deviation 442 |
| Systemic Dexamethasone | Duration of Sensory Block | 566 minutes | Standard Deviation 428 |
Duration of Motor Block
Defined as time from completion of block procedure to return to baseline motor function (in hours)
Time frame: 1 day postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perineural Dexamethasone | Duration of Motor Block | 18.5 hours | Standard Deviation 13.8 |
| Systemic Dexamethasone | Duration of Motor Block | 20.3 hours | Standard Deviation 22.3 |
Infection
Number of participants with localized infection at nerve block site
Time frame: 7 Days postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Perineural Dexamethasone | Infection | 0 Participants |
| Systemic Dexamethasone | Infection | 0 Participants |
Number of Participants With Nerve Damage From Interscalene Block
Defined as persistent paresthesia, and sensory/motor block at 7 days
Time frame: 7 Days postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Perineural Dexamethasone | Number of Participants With Nerve Damage From Interscalene Block | 0 Participants |
| Systemic Dexamethasone | Number of Participants With Nerve Damage From Interscalene Block | 0 Participants |
Number of Participants With Postoperative Nausea and/or Vomiting
Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively
Time frame: 7 days postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Perineural Dexamethasone | Number of Participants With Postoperative Nausea and/or Vomiting | 32 Participants |
| Systemic Dexamethasone | Number of Participants With Postoperative Nausea and/or Vomiting | 32 Participants |
Numeric Rating Scale for Pain (NRS 0-10)
Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better.
Time frame: 7 days postoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Perineural Dexamethasone | Numeric Rating Scale for Pain (NRS 0-10) | 7 days | 3.1 units on a scale | Standard Deviation 2.3 |
| Perineural Dexamethasone | Numeric Rating Scale for Pain (NRS 0-10) | 24hours | 4.9 units on a scale | Standard Deviation 2.6 |
| Perineural Dexamethasone | Numeric Rating Scale for Pain (NRS 0-10) | 12hours | 3.3 units on a scale | Standard Deviation 3 |
| Systemic Dexamethasone | Numeric Rating Scale for Pain (NRS 0-10) | 7 days | 3.4 units on a scale | Standard Deviation 2.4 |
| Systemic Dexamethasone | Numeric Rating Scale for Pain (NRS 0-10) | 24hours | 4.7 units on a scale | Standard Deviation 2.6 |
| Systemic Dexamethasone | Numeric Rating Scale for Pain (NRS 0-10) | 12hours | 3.3 units on a scale | Standard Deviation 2.9 |
Opioid Consumption
Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours, and 7 days
Time frame: 7 days postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perineural Dexamethasone | Opioid Consumption | 148.8 mg (oral morphine equivalent) | Standard Deviation 117.9 |
| Systemic Dexamethasone | Opioid Consumption | 167.2 mg (oral morphine equivalent) | Standard Deviation 140 |
Post-operative Oxygen Saturation on Room Air
Pulse oximetry (in %) measured 1 hour after arrival in post-operative recovery room, scale 0-100, higher number is better
Time frame: 1 hour postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perineural Dexamethasone | Post-operative Oxygen Saturation on Room Air | 96.6 Room air oxygen saturation percent | Standard Deviation 2.3 |
| Systemic Dexamethasone | Post-operative Oxygen Saturation on Room Air | 97.0 Room air oxygen saturation percent | Standard Deviation 2.4 |
Postoperative Serum Blood Glucose
Measured 1 hour after arrival to the post-operative recovery room
Time frame: 1 hour postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perineural Dexamethasone | Postoperative Serum Blood Glucose | 6.8 mmol/L | Standard Deviation 1 |
| Systemic Dexamethasone | Postoperative Serum Blood Glucose | 6.6 mmol/L | Standard Deviation 1.1 |
Time to First Opioid Consumption
Defined as time from completion of block procedure to first consumption of opioid analgesic (in hours)
Time frame: 1 day postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perineural Dexamethasone | Time to First Opioid Consumption | 9.1 hours | Standard Deviation 6.9 |
| Systemic Dexamethasone | Time to First Opioid Consumption | 9.6 hours | Standard Deviation 10.8 |