Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block

Surgery Clinical Trial

— TwoDex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05389852
• Other study ID #: Hopitalduvalais
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: February 7, 2024

Study information

• Verified date: March 2023
• Source: Hôpital du Valais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 7, 2024
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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

Locations

Country	Name	City	State
Switzerland	Hopital du Valais	Sion

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital du Valais

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of analgesia	time in minutes from end of injection of local anesthetic till first analgesic request	24 hours on day of surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cumulative amount of opiate analgesic medication consumed	in intravenous morphine equivalents (mg)	24, 48 hours postoperatively
Secondary	Patient satisfaction	on 4 point Likert scale: dissatisfied / neutral / satisfied / extremely satisfied	7 days postoperatively
Secondary	Total number of dexmedetomidine-related side effects	Total number of dexmedetomidine-related side effects, in particular bradycardia and hypotension	24 hours postoperatively
Secondary	Dexmedetomidine-related side effects	Number and % of patients who experience at least one dexmedetomidine-related side effect	24 hours postoperatively
Secondary	Opioid-related side effect	Number and % of patients who experience at least one opioid-related side effect	24 hours postoperatively