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

Efficacy of Combined US-Guided Supraclavicular Block and Interscalene Analgesia Versus an Intercostobrachial Nerve Block Versus PCA With Fentanyl on Preventing Tourniquet Pain in Forearm Surgery: A Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Tourniquet Pain; Forearm Surgery; US-Guided Supraclavicular Block; Interscalene Analgesia
• Intervention / Treatment: Drug: bupivacaine, midazolam

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Neveen A. Kohaf, Ph.D; Phone Number: +201069482380; Email: nevenabdo@azhar.edu.eg

Study Locations

• Egypt
  • Damietta, Egypt, 34711
    • Recruiting
    • Facualty of Medicine(Damietta), Al Azhar University
    • Contact: Neveen A. Kohaf, Ph.D; Phone Number: 01069482380; Email: nevenabdo@azhar.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: interscalene analgesia (Group ISBPB); 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.	Drug: bupivacaine, midazolam; Patients will be provided with midazolam (up to 2 mg) if requested. No opioids will be administered before the incision. At the first patient complaint of pain, the intraoperative anesthesia team will document the quality and location of pain, and 50 microgram of fentanyl will be administered if the patient requested it or pain score more than 3
Active Comparator: The intercostobrachial nerve block ( Group ICBN); 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.	Drug: bupivacaine, midazolam; Patients will be provided with midazolam (up to 2 mg) if requested. No opioids will be administered before the incision. At the first patient complaint of pain, the intraoperative anesthesia team will document the quality and location of pain, and 50 microgram of fentanyl will be administered if the patient requested it or pain score more than 3
Active Comparator: Patient-Controlled Analgesia (Group PCA); 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.	Drug: bupivacaine, midazolam; Patients will be provided with midazolam (up to 2 mg) if requested. No opioids will be administered before the incision. At the first patient complaint of pain, the intraoperative anesthesia team will document the quality and location of pain, and 50 microgram of fentanyl will be administered if the patient requested it or pain score more than 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of tourniquet pain	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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamics	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.	2 hours
The incidence of adverse reactions	The incidence of adverse reactions (Pneumothorax, Horner's syndrome) will be evaluated.	2 hours
Patients' satisfaction	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.	24 hours

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Intercostobrachial Nerve Block; PCA with Fentanyl
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anilides; Amides; Aniline Compounds; Amines; Benzazepines; Benzodiazepines; Bupivacaine; Midazolam
• Other Study ID Numbers: IRB 00012367-22-011-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared with a reasonable request from the corresponding auther
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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