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

NCT05602636 | Recruiting Phase 4

• 1 other identifier: IRB 00012367-22-011-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Forearm Surgery; US-Guided Supraclavicular Block; Interscalene Analgesia; Tourniquet Pain

Keywords

Intercostobrachial Nerve Block; PCA with Fentanyl

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hemodynamics

  2 hours

• The incidence of adverse reactions

  2 hours

• Patients' satisfaction

  24 hours

Study Arms (3)

interscalene analgesia (Group ISBPB)

ACTIVE COMPARATOR

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

The intercostobrachial nerve block ( Group ICBN)

ACTIVE COMPARATOR

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

Patient-Controlled Analgesia (Group PCA)

ACTIVE COMPARATOR

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

Interventions

bupivacaine, midazolam DRUG

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

Patient-Controlled Analgesia (Group PCA); The intercostobrachial nerve block ( Group ICBN); interscalene analgesia (Group ISBPB)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Facualty of Medicine(Damietta), Al Azhar University

Damietta, 34711, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine; Midazolam

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Neveen A. Kohaf, Ph.D

CONTACT

+201069482380; nevenabdo@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 2, 2022
• Study Start: December 10, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)