Efficacy of Different Medications as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries

Not Applicable

Active, not recruiting

• Conditions: Upper Limb Surgery; Brachial Plexus Blockade

• Registration Number: NCT06949488
• Lead Sponsor: Al-Azhar University

Brief Summary

This study is to evaluate whether addition of dexmedetomidine, dexamethasone and magnesium sulfate as adjuvants to bupivacaine in supraclavicular Brachial Plexus Blockade (BPB) for pain management assessed by VAS score.

Detailed Description

This is a randomized controlled study involving 105 participants divided into three groups to assess the efficacy of adding dexmedetomidine, dexamethasone, and magnesium sulfate as adjuvants to bupivacaine in supraclavicular brachial plexus blockade during upper limb surgeries. The primary outcome is the postoperative Visual Analog Scale (VAS) score. The secondary outcomes are assessment of onset and duration of the block, patient satisfaction, and adverse effects.

Study Timeline

• Study Start: 2024-12-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-29
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• American Society of Anesthesiologists (ASA) status of I and II
• undergoing forearm surgeries

Exclusion Criteria

• coagulopathies
• Local skin lesions
• Pregnancy
• Has a history of significant neurological, psychiatric, or neuromuscular disorders
• Patients refusing participation
• BMI > 40
• Patient with COPD. hypersensitivity or allergies to local anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
-Post operative Visual analogue scale VAS score	Over 24 hours post operative starting from transeferring the patient to the recovery area.	Assess post-operative VAS score at: T0 (after transferring to the recovery area), at T1: at two hours, T3: at four hours, T4: at six hours, T5: at eight hours, T6: at 10 hours, T7: at 12 hours, T8: at 16 hours, T9: at 20 hours, and T10 at 24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
Postoperative transient neurologic symptoms	Over 48 hours post operative starting from transeferring to the recovery area.	Dysesthesia will be assessed every 12 hours postoperatively and reported
Onst of sensory block	Complete sensory block will be assessed every 5 min up to a maximum of 30 minutes	Time in minutes from completing the block to complete sensory loss to sensation of a cold cotton pad relative to the contralateral limb.
Onset of motor block	Complete motor block will be assessed every 5 min up to a maximum of 30 minutes	Time in minutes from completing the block up to the time when the patient is unable to overcome gravity relative to the contralateral arm.
Duration of the sensory block	Sensation will be assessed every 4 hours till return of normal sensation up to maximum 24 hours .	Complete return of the sensation in the blocked limb relative to the contralateral arm.
duration of the motor block	Motor power will be assessed every 4 hours till return of normal sensation up to maximum 24 hourswill be assessed every 4 hours till return of normal sensation up to maximum 24 hours	Complete return of the motor power in the blocked limb
Intraoperative mean arterial blood pressure	From positioning the patient to the block upto 90 minutes from removing the needle	Mean arterial blood pressure in mmHg will be assessed at T0: baseline before patient positing for the block, at T1: just after removing the needle, at T2: at 30 minutes, T3: at 60 Minutes , and T4: at 90 minutes intraoperatively
Intraoperative Pulse rate.	From positioning the patient to the block upto 90 minutes from removing the needle	pulse rate per minute will be assessed at T0: baseline before patient positing for the block, at T1: just after removing the needle, at T2: at 30 minutes, T3: at 60 Minutes, and T4: at 90 minutes intraoperatively
Post operative opioid consumption	Over 24 hours post operatively started form transferring the patient to the recovery area	Postoperative total doses of pethidine in milligrams will be counted. For patients with a VAS score of more than 4, pethidine 50mg will be given intramuscularly.
Post operative Nausea and vomiting	Over 24 hours post operative starting from transferring to the recovery area.	Nausea and vomiting attacks will be recorded over 24 hours postoperatively.

Trial Locations

Locations (1)

Faculity of medicine - Al-Azhar University hospitals; 🇪🇬 Cairo, Egypt