Dexamethasone Versus Nalbuphine as Adjuvants in Brachial Plexus Block

Nalbuphine Versus Dexamethasone as an Adjuvant to Lidocaine / Bupivacaine Mixture in Ultrasound-guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Ultrasound (US) guided supraclavicular brachial plexus block

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al-Sharkia
    • Zagazig, Al-Sharkia, Egypt, 055
      • Faculty of medicine, Zagazig university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group I "Placebo"; 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.	Procedure: Ultrasound (US) guided supraclavicular brachial plexus block; Using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in ultrasound (US) guided supraclavicular brachial plexus block
Active Comparator: Group II "Nalbuphine "; 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).	Procedure: Ultrasound (US) guided supraclavicular brachial plexus block; Using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in ultrasound (US) guided supraclavicular brachial plexus block
Active Comparator: Group III "Dexamethasone"; 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).	Procedure: Ultrasound (US) guided supraclavicular brachial plexus block; Using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in ultrasound (US) guided supraclavicular brachial plexus block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postoperative analgesia	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.	First 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain score "Visual Analogue Score"	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.	First 24 hours after surgery
The total opioid consumption	Total dose of fentanyl as a rescue analgesic in the first 24 hours	First 24 hours after surgery

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Mohamed ELSayed, MSc, faculty of medicine, Zagazig university, Egypt; Study Chair: Ahmed mohamed Salama, MD, faculty of medicine, Zagazig university, Egypt; Study Chair: Ayman Abd-El Salam Hassan, MD, faculty of medicine, Zagazig university, Egypt; Study Director: Fatma Mahmoud Ahmed, MD, faculty of medicine, Zagazig university, Egypt

Publications and helpful links

General Publications

• Perlas A, Lobo G, Lo N, Brull R, Chan VW, Karkhanis R. Ultrasound-guided supraclavicular block: outcome of 510 consecutive cases. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):171-6. doi: 10.1097/AAP.0b013e31819a3f81.
• Abdallah FW, Johnson J, Chan V, Murgatroyd H, Ghafari M, Ami N, Jin R, Brull R. Intravenous dexamethasone and perineural dexamethasone similarly prolong the duration of analgesia after supraclavicular brachial plexus block: a randomized, triple-arm, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):125-32. doi: 10.1097/AAP.0000000000000210. Erratum In: Reg Anesth Pain Med. 2015 Jul-Aug;40(4):398.
• Das A, RoyBasunia S, Mukherjee A, Biswas H, Biswas R, Mitra T, Chattopadhyay S, Mandal SK. Perineural Nalbuphine in Ambulatory Upper Limb Surgery: A Comparison of Effects of Levobupivacaine with and without Nalbuphine as Adjuvant in Supraclavicular Brachial Plexus Block - A Prospective, Double-blinded, Randomized Controlled Study. Anesth Essays Res. 2017 Jan-Mar;11(1):40-46. doi: 10.4103/0259-1162.200225.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): May 5, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 8, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: brachial plexus block

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No