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Recruiting Phase 4 NCT05602636

NCT05602636 Analgesic Effect of Supraclavicular Block and Interscalene Analgesia Versus an Intercostobrachial Nerve Block Versus PCA in Forearm Surgery

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Clinical Trial Summary
NCT ID NCT05602636
Status Recruiting
Phase Phase 4
Sponsor Al-Azhar University
Condition Forearm Surgery
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2022-12-10
Primary Completion 2025-12-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 70 Years
Study Type INTERVENTIONAL
Interventions
bupivacaine, midazolam

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 60 participants in total. It began in 2022-12-10 with a primary completion date of 2025-12-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Neveen A. Kohaf, Ph.D

✉ nevenabdo@azhar.edu.eg

📞 +201069482380

Frequently Asked Questions

Who can join the NCT05602636 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Forearm Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT05602636 trial and what does that mean for participants?

Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.

Is NCT05602636 currently recruiting?

Yes, NCT05602636 is actively recruiting participants. Contact the research team at nevenabdo@azhar.edu.eg for enrollment information.

Where is the NCT05602636 trial being conducted?

This trial is being conducted at Damietta, Egypt.

Who is sponsoring the NCT05602636 clinical trial?

NCT05602636 is sponsored by Al-Azhar University. The trial plans to enroll 60 participants.

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