About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Contraindication to regional anesthesia.
Allergy to local anesthetics.
Primary block failure.
If patients desired deep intraoperative sedation.
Trial design
Parallel
Treatments tested in this trial
bupivacaine, midazolam
DrugPatients 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
The incidence of adverse reactions
The incidence of adverse reactions (Pneumothorax, Horner's syndrome) will be evaluated.
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.
Sponsors and contacts
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