Analgesic Effect of Supraclavicular Block and Interscalene Analgesia Versus an Intercostobrachial Nerve Block Versus PCA in Forearm Surgery

Phase 4

Recruiting

• Conditions: Interscalene Analgesia; Forearm Surgery; US-Guided Supraclavicular Block; Tourniquet Pain
• Interventions: Drug: bupivacaine, midazolam

• Registration Number: NCT05602636
• Lead Sponsor: Al-Azhar University

Brief Summary

The etiology of tourniquet pain is complex, and the study team hypothesizes that blocking with Interscalene brachial plexus block (ISBPB) is more efficient in decreasing the incidence of tourniquet pain in comparison with other techniques.

As there is a paucity of studies that evaluate the effect of intercostobrachial nerve (ICBN) block and ISBPB and Patient-Controlled Analgesia (PCA) with a supraclavicular brachial plexus block (SCBPB) on tourniquet pain in forearm surgery, Therefore, we established this randomized study to compare ISBPB and ICBN and PCA with fentanyl with SCBPB in terms of the incidence and severity of tourniquet pain in patients undergoing forearm surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-02
• Study Start: 2022-12-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• aged more than 18 years,
• ASAI-III patients
• scheduled to undergo orthopedic or plastic surgery distal to the elbow with an anticipated tourniquet duration greater than 45 min.
• desiring regional anesthesia as the primary anesthetic.

Exclusion Criteria

• Contraindication to regional anesthesia.
• Allergy to local anesthetics.
• Primary block failure.
• If patients desired deep intraoperative sedation.
• Clinically significant cognitive impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The intercostobrachial nerve block ( Group ICBN)	bupivacaine, midazolam	All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance. The ICBN block will be performed with 10 mL of 0.5% bupivacaine in the plane deep to the pectoralis minor and/or serratus anterior muscle over the second and third intercostal space.
interscalene analgesia (Group ISBPB)	bupivacaine, midazolam	All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance. The C5 to C7 or C5 to C8 nerve roots between the anterior scalene and middle scalene muscles will be visualized in the absence of the subclavian artery and 10 mL 0.125% bupivacaine will be injected around the nerve roots of the brachial plexus. The needle trajectory will be adjusted to facilitate the even distribution of the local anesthetic around each nerve root.
Patient-Controlled Analgesia (Group PCA)	bupivacaine, midazolam	All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance.

Primary Outcome Measures

Name	Time	Method
The incidence of tourniquet pain	2 hours	The incidence of tourniquet pain will be assessed by the patient's VAS score. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The patient is asked to rate their current level of pain by placing a mark on the line.

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction	24 hours	Patients' satisfaction will be measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.
Hemodynamics	2 hours	Hemodynamics up to 2 hours postoperative (heart rate, mean arterial blood pressure. Mean arterial blood pressure and heart rate will be recorded at baseline and every 5 min till the end of the procedure.
The incidence of adverse reactions	2 hours	The incidence of adverse reactions (Pneumothorax, Horner's syndrome) will be evaluated.

Trial Locations

Locations (1)

Facualty of Medicine(Damietta), Al Azhar University; 🇪🇬 Damietta, Egypt