Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block

NCT ID: NCT05389852

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-02-07

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.

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.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

intravenous dexmedetomidine

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

Other Intervention Names

Dexdor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital du Valais

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sina Grape, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Valais Hospital

Locations

Hopital du Valais

Sion, , Switzerland

Countries

Switzerland

Other Identifiers

Hopitalduvalais

Identifier Type: -

Identifier Source: org_study_id