Low Dose Dexamethasone in Supraclavicular Blocks

NCT02666443 | Unknown

• 1 other identifier: REB13-1350
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

Brachial plexus nerve blocks provide superior analgesia over opioids while avoiding unwanted side effects. Single shot blocks with local anesthetic alone usually do not last the duration of the acute post-surgical pain period. This has led to the exploration of multiple adjuvants to increase the duration of single shot blocks, the most promising adjuvant being dexamethasone. Peri-neural administration is an off-label use of dexamethasone. While no adverse events have been reported in human clinical studies, logic would dictate that we minimize the dose needed to produce the desired effect. Most studies thus far have used peri-neural dexamethasone doses ranging from 4-10 mg. However, Albrecht et al. found no difference in block duration comparing 4 mg and 8 mg doses while Liu et al. reported equivalent block duration using doses of 1, 2 and 4 mg. Recent studies have evaluated whether systemic and peri-neural administrations of dexamethasone are equivalent, which would in turn imply a site of action. Results have been mixed. Four studies concluded peri-neural and intravenous administration are equivalent at prolonging analgesia, though one study had methodological errors, including the administration of intravenous dexamethasone to all patients. All of these studies used dexamethasone doses of 8 to 10 mg. One study where a lower dose (4 mg) was used found that peri-neural administration prolonged block duration whereas intravenous did not. With that, the rationale of our study is to determine if equivalent block-prolonging analgesia can be achieved using low dose (1 mg) dexamethasone given peri-neural or intravenous. Clinical experience at our centre has been that 1 mg dexamethasone added to 20 mL produces similar block duration to that reported in published studies using higher doses.

Conditions

Rheumatoid Arthritis; Osteoarthritis; Nerve Entrapment; Ligament Injury

Keywords

brachial plexus; supraclavicular; duration; dexamethasone; block

Outcome Measures

Primary Outcomes (1)

• Time to first sensation of pain at the surgical site.

  72 hours

Secondary Outcomes (5)

• duration of motor blockade

  72 hours

• morphine or morphine equivalent usage in the first 48 h postoperatively

  48 hours

• incidence of nausea and vomiting and pruritus in the first 48 h

  48 hours

• numerical rating scale (NRS) pain scores at 8 h, 24 h, 48 h, and post-operative day 7

  7 days

• residual paraesthesias or motor blockade at 7 days.

  7 days

Study Arms (3)

Control (C)

PLACEBO COMPARATOR

Control intervention (no dexamethasone)

Drug: Control intervention (no dexamethasone)

Peri-neural (N)

EXPERIMENTAL

Peri-neural Dexamethasone 1 mg

Drug: Peri-neural Dexamethasone 1 mg

Intravenous

EXPERIMENTAL

Intravenous Dexamethasone 1 mg

Drug: Intravenous Dexamethasone 1 mg

Interventions

Control intervention (no dexamethasone) DRUG

Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL normal saline, and an intravenous solution of 50 mL normal saline.

Also known as: Control

Control (C)

Peri-neural Dexamethasone 1 mg DRUG

Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL dexamethasone 1% (1 mg dexamethasone), and an intravenous solution of 50 mL normal saline.

Also known as: Peri-neural

Peri-neural (N)

Intravenous Dexamethasone 1 mg DRUG

Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL normal saline, and an intravenous solution of 49.9 mL normal saline with 0.1mL dexamethasone 1%

Also known as: IV

Intravenous

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult 18 - 80 years
• BMI equal to or less than 35
• Upper limb surgery
• Normal pre-operative sensation in the operative limb

You may not qualify if:

• Pre-operative opioid greater than 4 Tylenol #3 per day (or equivalent)
• Pre-existing, fluctuating neurologic injury involving operative upper limb
• Patient refusal or patient inability to provide consent
• Patient pregnancy
• Patient BMI \> 35
• Patient allergy to any of the drugs used in the protocol
• Surgical concern of postoperative neurological injury from surgical manipulation.
• Brittle diabetics
• Other contraindication to receiving a block (coagulopathy, significant respiratory risk, etc.)

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

RECRUITING

Related Publications (23)

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  PMID: 24413428 BACKGROUND

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• Abdallah FW, Johnson J, Chan V, Murgatroyd H, Ghafari M, Ami N, Jin R, Brull R. Intravenous dexamethasone and perineural dexamethasone similarly prolong the duration of analgesia after supraclavicular brachial plexus block: a randomized, triple-arm, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):125-32. doi: 10.1097/AAP.0000000000000210.

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  BACKGROUND

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• Ultrasound for Regional Anesthesia, Supraclavicular Block. 2008; http://www.usra.ca/supneedle.php accessed September 22, 2015

  BACKGROUND

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  PMID: 21676892 BACKGROUND

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MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Nerve Compression Syndromes; Bites and Stings

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Nathan JD Brown, BMSc, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan JD Brown, BMSc, MD

CONTACT

403-956-3883; nathan.brown@albertahealthservices.ca

Melissa T Jack, MD, PhD

CONTACT

403-956-3883; melissa.jack@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist, Calgary Department of Anesthesia

Study Record Dates

• First Submitted: January 24, 2016
• First Posted: January 28, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

CA (1)