Dexamethasone Versus Nalbuphine as Adjuvants in Brachial Plexus Block

NCT04194320 | Completed

• 1 other identifier: Brachial Plexus Block
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• post operative pain score "Visual Analogue Score"

  First 24 hours after surgery

• The total opioid consumption

  First 24 hours after surgery

Study Arms (3)

Group I "Placebo"

PLACEBO COMPARATOR

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

Group II "Nalbuphine "

ACTIVE COMPARATOR

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

Group III "Dexamethasone"

ACTIVE COMPARATOR

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

Interventions

Ultrasound (US) guided supraclavicular brachial plexus block PROCEDURE

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

Group I "Placebo"; Group II "Nalbuphine "; Group III "Dexamethasone"

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, Zagazig University

Zagazig, Al-Sharkia, 055, Egypt

Location

Related Publications (3)

• 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.

  PMID: 25629321 BACKGROUND

• 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.

  PMID: 28298754 BACKGROUND

• 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.

  PMID: 19282715 BACKGROUND

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Mohamed ELSayed, MSc

  Faculty of medicine, zagazig university, Egypt

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Fatma Mahmoud Ahmed, MD

  Faculty of medicine, zagazig university, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 11, 2019
• Study Start: December 1, 2019
• Primary Completion: May 5, 2020
• Study Completion: June 15, 2020
• Last Updated: October 1, 2024

Record last verified: 2020-07

Locations

EG (1)