Dexamethasone Versus Nalbuphine as Adjuvants in Brachial Plexus Block

NCT ID: NCT04194320

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2020-06-15

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Ultrasound (US) guided supraclavicular brachial plexus block

Intervention Type: 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 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).

Group Type: ACTIVE_COMPARATOR

Ultrasound (US) guided supraclavicular brachial plexus block

Intervention Type: 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 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).

Group Type: ACTIVE_COMPARATOR

Ultrasound (US) guided supraclavicular brachial plexus block

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed ELSayed, MSc

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine, zagazig university, Egypt

Ahmed mohamed Salama, MD

Role: STUDY_CHAIR

Faculty of medicine, zagazig university, Egypt

Ayman Abd-El Salam Hassan, MD

Role: STUDY_CHAIR

Faculty of medicine, zagazig university, Egypt

Fatma Mahmoud Ahmed, MD

Role: STUDY_DIRECTOR

Faculty of medicine, zagazig university, Egypt

Locations

Faculty of medicine, Zagazig University

Zagazig, Al-Sharkia, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 25629321 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28298754 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19282715 (View on PubMed)

Other Identifiers

Brachial Plexus Block

Identifier Type: -

Identifier Source: org_study_id