Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block

NCT05389852 | Completed Phase 4 DMC

• 1 other identifier: Hopitalduvalais
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to compare the duration of analgesia in patients undergoing forearm or hand surgery with a supraclavicular brachial plexus block, who receive either iv dexmedetomidine or placebo.

Conditions

Surgery

Keywords

locoregional anesthesia; postoperative analgesia; hand surgery; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• duration of analgesia

  time in minutes from end of injection of local anesthetic till first analgesic request

  24 hours on day of surgery

Secondary Outcomes (9)

• Duration of motor block

  24 hours on day of surgery

• Duration of sensory block

  24 hours on day of surgery

• Pain scores at rest

  4, 24, 48 hours postoperatively

• Pain scores on movement

  4, 24, 48 hours postoperatively

• Cumulative amount of opiate analgesic medication consumed

  24, 48 hours postoperatively

Study Arms (2)

intravenous dexmedetomidine

ACTIVE COMPARATOR

Patients will receive intravenous dexmedetomidine 1 mcg/kg just after the supraclavicular brachial plexus block is completed

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

Patients will receive intravenous placebo (normal saline) just after the supraclavicular brachial plexus is completed

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

After completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg

Also known as: Dexdor

Placebo; intravenous dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elbow, forearm or hand surgery under supraclavicular brachial plexus block Patients who are ASA physical status I-III

You may not qualify if:

• Patient refusal
• ASA physical status IV
• History of hypersensitivity or intolerance to dexmedetomidine
• History of hypersensitivity or intolerance to dexamethasone
• History of hypersensitivity or intolerance to local anesthetics
• History of recent (\< 1 year) cerebrovascular insult
• Second or third degree heart block
• Uncontrolled hypotension
• Conditions contraindicating supraclavicular brachial plexus block: neurological deficit or neuropathy of the arm, severe hepatic dysfunction (Child B and C), coagulopathy, malignancy or infection in the area above the clavicle
• Chronic opioid use
• Pregnancy

Sponsors & Collaborators

• Hôpital du Valais: lead

Study Sites (1)

Hopital du Valais

Sion, 1950, Switzerland

Location

Related Publications (1)

• Grape S, Andany A, Cibotto C, Berri L, Rossel JB, Albrecht E. Duration of analgesia after supraclavicular brachial plexus block with intravenous dexamethasone with or without dexmedetomidine: a randomised, placebo-controlled, triple-blind trial. Br J Anaesth. 2025 Dec 1:S0007-0912(25)00792-5. doi: 10.1016/j.bja.2025.10.049. Online ahead of print.

  PMID: 41330797 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sina Grape, MD, MBA

  Valais Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: dexmedetomidine or placebo prepared by Lausanne University Hospital Pharmacy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients undergoing forearm or hand surgery under supraclavicular brachial plexus block, receiving either additional intravenous dexmedetomidine or placebo

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 25, 2022
• Study Start: January 1, 2023
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: February 8, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)