Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block (TwoDex)

Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block: a Randomized Double-blinded Placebo Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Drug: Dexmedetomidine

Detailed Description

Most surgical interventions on the forearm and the hand in Valais Hospital are performed under regional anesthesia. This ensures intraoperative patient comfort and reduces pain during the first 6 to 12 postoperative hours. A very common strategy to provide anesthesia of the arm is to inject local anesthetics in the region over the clavicle around the brachial plexus. This "supraclavicular brachial plexus block" is routinely performed in Valais Hospital and is always done under ultrasound guidance.

A drawback of locoregional anesthesia is the recurrence of pain once the effect of the block wears off after approximately 6 to 8 hours. This phenomenon is called rebound pain. It and can be very severe and debilitating, can significantly impact postoperative recovery and may also preclude ambulatory surgery as well as early mobilization and physiotherapy. Therefore, strategies that prolong the analgesic effect of locoregional anesthesia are warranted.

Dexmedetomidine is a selective α2-adrenoceptor agonists with sedative and analgesic properties. It has been shown to prolong the analgesic duration of local anesthetics when administered intravenously. However, the association of dexmedetomidine with long-acting local anesthetics for supraclavicular brachial plexus block has not been systematically investigated.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Sion, Switzerland, 1950
    • Hôpital du Valais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intravenous dexmedetomidine; Patients will receive intravenous dexmedetomidine 1 mcg/kg just after the supraclavicular brachial plexus block is completed	Drug: Dexmedetomidine; After completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg; Other Names: Dexdor
Placebo Comparator: Placebo; Patients will receive intravenous placebo (normal saline) just after the supraclavicular brachial plexus is completed	Drug: Dexmedetomidine; After completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg; Other Names: Dexdor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of analgesia	time in minutes from end of injection of local anesthetic till first analgesic request	24 hours on day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of motor block	time in minutes from completion of locoregional anesthesia and the moment the patient can again mobilize the arm	24 hours on day of surgery
Duration of sensory block	time in minutes from completion of locoregional anesthesia and the moment the patient regains sensation of the arm	24 hours on day of surgery
Pain scores at rest	Pain scores at rest on numeric scale, 0=no pain at all to 10=worst pain imaginable	4, 24, 48 hours postoperatively
Pain scores on movement	Pain scores on movement, on numeric scale, 0=no pain at all to 10=worst pain imaginable	4, 24, 48 hours postoperatively
Cumulative amount of opiate analgesic medication consumed	in intravenous morphine equivalents (mg)	24, 48 hours postoperatively
Patient satisfaction	on 4 point Likert scale: dissatisfied / neutral / satisfied / extremely satisfied	7 days postoperatively
Total number of dexmedetomidine-related side effects	Total number of dexmedetomidine-related side effects, in particular bradycardia and hypotension	24 hours postoperatively
Dexmedetomidine-related side effects	Number and % of patients who experience at least one dexmedetomidine-related side effect	24 hours postoperatively
Opioid-related side effect	Number and % of patients who experience at least one opioid-related side effect	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Hôpital du Valais
• Investigators: Principal Investigator: Sina Grape, MD, MBA, Valais Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): February 7, 2024
• Study Completion (Actual): February 7, 2024

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 21, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: dexmedetomidine; postoperative analgesia; hand surgery; locoregional anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: Hopitalduvalais

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No