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Recruiting NCT05602636

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

Phase IV Interventional Forearm Surgery US-Guided Supraclavicular Block Interscalene Analgesia Tourniquet Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bupivacaine, midazolam.
Who it may be relevant to
Registry conditions: Forearm Surgery, US-Guided Supraclavicular Block, Interscalene Analgesia, Tourniquet Pain. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • The incidence of tourniquet pain [Time frame: 2 hours]
Secondary outcome measures (3)
  • Hemodynamics [Time frame: 2 hours]
  • The incidence of adverse reactions [Time frame: 2 hours]
  • Patients' satisfaction [Time frame: 24 hours]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Facualty of Medicine(Damietta), Al Azhar University — Damietta

Identifiers

NCT: NCT05602636 · IRB 00012367-22-011-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗