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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Forearm Surgery, US-Guided Supraclavicular Block, Interscalene Analgesia, Tourniquet Pain

Intervention / Treatment
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* Drug: bupivacaine, midazolam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: interscalene analgesia (Group ISBPB)<br>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<br>* 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<br>|
| Active Comparator: The intercostobrachial nerve block ( Group ICBN)<br>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<br>* 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<br>|
| Active Comparator: Patient-Controlled Analgesia (Group PCA)<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The incidence of adverse reactions | The incidence of adverse reactions (Pneumothorax, Horner's syndrome) will be evaluated. | 2 hours | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intercostobrachial Nerve Block, PCA with Fentanyl