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

Tourniquet Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602636
• Other study ID #: IRB 00012367-22-011-003
• Status: Recruiting
• Phase: Phase 4
• Start date: December 10, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Al-Azhar University
• Contact: Neveen A. Kohaf, Ph.D
• Phone: +201069482380
• Email: nevenabdo[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Forearm Surgery
• Tourniquet Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	Facualty of Medicine(Damietta), Al Azhar University	Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The incidence of adverse reactions	The incidence of adverse reactions (Pneumothorax, Horner's syndrome) will be evaluated.	2 hours
Secondary	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