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The Effects of Dexamethasone on Low Dose Interscalene Brachial Plexus Block

Comparison of the Effects of Perineural Versus Systemic Dexamethasone on Low Dose Interscalene Brachial Plexus Block: A Randomized Control Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02322242
Acronym
ISB-Dex
Enrollment
182
Registered
2014-12-23
Start date
2015-01-31
Completion date
2019-05-31
Last updated
2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Surgery, Nerve Block

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

The Physicians' Services Incorporated Foundation
CollaboratorOTHER
Dr. Stephen Choi
Lead SponsorOTHER

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 80 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Duration of Sensory Block1 day postoperativeDefined as time from completion of block procedure to NRS for pain \> 0 (in hours)

Secondary

MeasureTime frameDescription
Duration of Motor Block1 day postoperativeDefined as time from completion of block procedure to return to baseline motor function (in hours)
Post-operative Oxygen Saturation on Room Air1 hour postoperativePulse oximetry (in %) measured 1 hour after arrival in post-operative recovery room, scale 0-100, higher number is better
Opioid Consumption7 days postoperativeOpioid 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 postoperativeRecorded 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 Consumption1 day postoperativeDefined as time from completion of block procedure to first consumption of opioid analgesic (in hours)
Number of Participants With Nerve Damage From Interscalene Block7 Days postoperativeDefined as persistent paresthesia, and sensory/motor block at 7 days
Infection7 Days postoperativeNumber of participants with localized infection at nerve block site
Number of Participants With Postoperative Nausea and/or Vomiting7 days postoperativeNumber of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively
Postoperative Serum Blood Glucose1 hour postoperativeMeasured 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

ArmCount
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
Total182

Baseline characteristics

CharacteristicPerineural DexamethasoneSystemic DexamethasoneTotal
Age, Continuous51.6 years52.8 years52.2 years
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
25 Participants21 Participants46 Participants
Sex: Female, Male
Male
67 Participants69 Participants136 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 920 / 90
other
Total, other adverse events
0 / 920 / 90
serious
Total, serious adverse events
0 / 920 / 90

Outcome results

Primary

Duration of Sensory Block

Defined as time from completion of block procedure to NRS for pain \> 0 (in hours)

Time frame: 1 day postoperative

ArmMeasureValue (MEAN)Dispersion
Perineural DexamethasoneDuration of Sensory Block521 minutesStandard Deviation 442
Systemic DexamethasoneDuration of Sensory Block566 minutesStandard Deviation 428
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Perineural DexamethasoneDuration of Motor Block18.5 hoursStandard Deviation 13.8
Systemic DexamethasoneDuration of Motor Block20.3 hoursStandard Deviation 22.3
Secondary

Infection

Number of participants with localized infection at nerve block site

Time frame: 7 Days postoperative

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Perineural DexamethasoneInfection0 Participants
Systemic DexamethasoneInfection0 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Perineural DexamethasoneNumber of Participants With Nerve Damage From Interscalene Block0 Participants
Systemic DexamethasoneNumber of Participants With Nerve Damage From Interscalene Block0 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Perineural DexamethasoneNumber of Participants With Postoperative Nausea and/or Vomiting32 Participants
Systemic DexamethasoneNumber of Participants With Postoperative Nausea and/or Vomiting32 Participants
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Perineural DexamethasoneNumeric Rating Scale for Pain (NRS 0-10)7 days3.1 units on a scaleStandard Deviation 2.3
Perineural DexamethasoneNumeric Rating Scale for Pain (NRS 0-10)24hours4.9 units on a scaleStandard Deviation 2.6
Perineural DexamethasoneNumeric Rating Scale for Pain (NRS 0-10)12hours3.3 units on a scaleStandard Deviation 3
Systemic DexamethasoneNumeric Rating Scale for Pain (NRS 0-10)7 days3.4 units on a scaleStandard Deviation 2.4
Systemic DexamethasoneNumeric Rating Scale for Pain (NRS 0-10)24hours4.7 units on a scaleStandard Deviation 2.6
Systemic DexamethasoneNumeric Rating Scale for Pain (NRS 0-10)12hours3.3 units on a scaleStandard Deviation 2.9
Secondary

Opioid Consumption

Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours, and 7 days

Time frame: 7 days postoperative

ArmMeasureValue (MEAN)Dispersion
Perineural DexamethasoneOpioid Consumption148.8 mg (oral morphine equivalent)Standard Deviation 117.9
Systemic DexamethasoneOpioid Consumption167.2 mg (oral morphine equivalent)Standard Deviation 140
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Perineural DexamethasonePost-operative Oxygen Saturation on Room Air96.6 Room air oxygen saturation percentStandard Deviation 2.3
Systemic DexamethasonePost-operative Oxygen Saturation on Room Air97.0 Room air oxygen saturation percentStandard Deviation 2.4
Secondary

Postoperative Serum Blood Glucose

Measured 1 hour after arrival to the post-operative recovery room

Time frame: 1 hour postoperative

ArmMeasureValue (MEAN)Dispersion
Perineural DexamethasonePostoperative Serum Blood Glucose6.8 mmol/LStandard Deviation 1
Systemic DexamethasonePostoperative Serum Blood Glucose6.6 mmol/LStandard Deviation 1.1
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Perineural DexamethasoneTime to First Opioid Consumption9.1 hoursStandard Deviation 6.9
Systemic DexamethasoneTime to First Opioid Consumption9.6 hoursStandard Deviation 10.8

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026