Dexamethasone Versus Nalbuphine as Adjuvants in Brachial Plexus Block

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Procedure: Ultrasound (US) guided supraclavicular brachial plexus block

• Registration Number: NCT04194320
• Lead Sponsor: Zagazig University

Brief Summary

Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of dexamethasone or nalbuphine as adjuvants to local anesthetics in supraclavicular brachial plexus block for upper limb surgeries.

Detailed Description

Upper-limb surgeries can be performed under either general or regional anesthesia.However, regional anesthesia has the advantages of long-lasting pain relief \& avoidance of airway instrumentation.Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to local anesthetics mixture (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in Ultrasound-guided supraclavicular brachial plexus block for upper limb surgeries below the level of the shoulder.

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2019-12-08
• Study First Posted: 2019-12-11
• Primary Completion: 2020-05-05
• Study Completion: 2020-06-15
• Status Verified: 2020-07
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patient acceptance.
• American Society of Anesthesiologists (ASA) I and (ASA) II.
• Age 21-60 years old.
• Both gender.
• BMI < 30.
• Accepted mental state of the patient.
• Unilateral upper limb surgeries below the level of the shoulder.

Exclusion Criteria

• Patient refusal.
• Peripheral neuropathy.
• Pathological coagulopathy.
• Infection at the injection site.
• History of active substance abuse.
• Untreated pneumothorax.
• Disturbed conscious level.
• An allergy to local anesthetics or nalbuphine or dexamethasone.
• Planned for receiving general anesthesia during the same operation for any cause.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I "Placebo"	Ultrasound (US) guided supraclavicular brachial plexus block	Ultrasound (US) guided supraclavicular brachial plexus block will be done to the patients who are prepared to undergo upper limb surgeries below the level of the shoulder within the distribution of supraclavicular brachial plexus block using: 30 mL volume of local anesthetics (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) + 2 ml 0.9% normal saline.
Group II "Nalbuphine "	Ultrasound (US) guided supraclavicular brachial plexus block	Ultrasound (US) guided supraclavicular brachial plexus block will be done to the patients who are prepared to undergo upper limb surgeries below the level of the shoulder within the distribution of supraclavicular brachial plexus block using: 30 mL volume of local anesthetics (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) + 10 mg nalbuphine hydrochloride (completed to 2 ml with 0.9% normal saline).
Group III "Dexamethasone"	Ultrasound (US) guided supraclavicular brachial plexus block	Ultrasound (US) guided supraclavicular brachial plexus block will be done to the patients who are prepared to undergo upper limb surgeries below the level of the shoulder within the distribution of supraclavicular brachial plexus block using: 30 mL volume of local anesthetics (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) + 2 mL dexamethasone 0.4% (8 mg).

Primary Outcome Measures

Name	Time	Method
Duration of postoperative analgesia	First 24 hours after surgery	Time between onset of sensory block to the first report of postoperative pain at the surgical site that has a VAS "visual analogue score" ≥ 4.

Secondary Outcome Measures

Name	Time	Method
The total opioid consumption	First 24 hours after surgery	Total dose of fentanyl as a rescue analgesic in the first 24 hours
post operative pain score "Visual Analogue Score"	First 24 hours after surgery	On a scale of 0-10, the patient will be asked to quantify postoperative pain as the following: 0: No pain 10: Maximum/worst imaginable pain. Visual Analog Scale assessment will be done every 5 minutes for first 30 minutes, then hourly for first 8 hours then every 4 hourly till patient complained of pain equivalent to a VAS score of 4. Rescue analgesia (injection of fentanyl 25 mcg intravenous increments) up to 200 μg/hour is administered when VAS score reached 4.

Trial Locations

Locations (1)

Faculty of medicine, Zagazig University; 🇪🇬 Zagazig, Al-Sharkia, Egypt