Dexamethasone Versus Nalbuphine as Adjuvants in Brachial Plexus Block

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194320
• Other study ID #: Brachial Plexus Block
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: July 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 15, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Zagazig University	Zagazig	Al-Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & 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. Erratum in: Reg Anesth Pain Med. 2015 Jul-Aug;40(4):398. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The total opioid consumption	Total dose of fentanyl as a rescue analgesic in the first 24 hours	First 24 hours after surgery