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NCT Number: NCT05602636

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

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.

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Key information

Conditions

Forearm Surgery Interscalene Analgesia Tourniquet Pain US-Guided Supraclavicular Block

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Facualty of Medicine(Damietta), Al Azhar University

Damietta, 34711, Egypt

Location status: Recruiting

Location contact

Neveen A. Kohaf, Ph.D

CONTACT

[email protected]

01069482380

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. The incidence of tourniquet pain

    Time frame: 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 outcomes

  1. Hemodynamics

    Time frame: 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.

  2. The incidence of adverse reactions

    Time frame: 2 hours

    The incidence of adverse reactions (Pneumothorax, Horner's syndrome) will be evaluated.

  3. Patients' satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Neveen A. Kohaf, Ph.D

CONTACT

[email protected]

+201069482380

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 2, 2022
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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