The Effect of Dexamethasone Adjuvant to Varying Doses of Bupivacaine on Motor and Sensory Blockade in Infraclavicular Brachial Plexus Blockade

NCT06769581 | Active Not Recruiting

• 1 other identifier: 159
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, prospective, randomized, double-blinded controlled trial investigates the effects of adding 4 mg dexamethasone to different concentrations of bupivacaine on motor and sensory block duration in infraclavicular brachial plexus block. A total of 120 ASA I-II patients aged 18-65 undergoing elective surgeries of the hand, wrist, forearm, or elbow will be randomly assigned to one of four groups: Group 1: 25 mL of 0.5% bupivacaine. Group 2: 25 mL of 0.5% bupivacaine with 4 mg dexamethasone. Group 3: 25 mL of 0.375% bupivacaine with 4 mg dexamethasone. Group 4: 25 mL of 0.25% bupivacaine with 4 mg dexamethasone. The infraclavicular block will be performed using a lateral sagittal approach under ultrasound and nerve stimulator guidance. Primary outcomes include the duration of motor and sensory block, assessed with a motor block scale and pin-prick sensory test. Secondary outcomes include block onset times, postoperative pain scores (Visual Analog Scale), total analgesic consumption within 48 hours, time to first postoperative analgesic, and rates of rescue block or conversion to general anesthesia. This study aims to evaluate whether combining dexamethasone with lower concentrations of bupivacaine can maintain block efficacy while reducing local anesthetic dosage, potentially improving the safety and effectiveness of peripheral nerve block protocols.

Conditions

Infraclavicular Brachial Plexus Block; Dexamethasone Administration; Bupivacaine

Keywords

infraclavicular brachial plexus block; dexamethasone; bupivacaine; concentration

Outcome Measures

Primary Outcomes (1)

• Duration of motor and sensory block

  The primary outcome of this study is to examine the effects of different concentrations of bupivacaine combined with dexamethasone, in the same volume, on the duration of motor block and sensory block during infraclavicular brachial plexus block.

  48 hours

Secondary Outcomes (4)

• Block Onset Time

  30 minutes

• Postoperative pain levels

  48 hours

• Total analgesic requirements

  48 hours

• Block Failure

  30 minutes

Study Arms (4)

Group 1: 0.5% bupivacaine only

ACTIVE COMPARATOR

Group 1: 25 ml of 0.5% bupivacaine for infraclavicular brachial plexus block

Procedure: Infraclavicular Brachial Plexus Blocks

Group 2: 25 ml of 0.5% Bupivacaine and 4 mg Dexamethasone

EXPERIMENTAL

Group 2: 25 ml of 0.5% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block

Procedure: Infraclavicular Brachial Plexus Blocks

Group 3: 25 ml of 0.375% Bupivacaine and 4 mg Dexamethasone

EXPERIMENTAL

"Group 3: 25 ml of 0.375% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block.

Procedure: Infraclavicular Brachial Plexus Blocks

Group 4: 25 ml of 0.25% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution

EXPERIMENTAL

Group 4: 25 ml of 0.25% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block.

Procedure: Infraclavicular Brachial Plexus Blocks

Interventions

Infraclavicular Brachial Plexus Blocks PROCEDURE

Lateral sagittal technique infraclavicular brachial plexus block

Group 1: 0.5% bupivacaine only; Group 2: 25 ml of 0.5% Bupivacaine and 4 mg Dexamethasone; Group 3: 25 ml of 0.375% Bupivacaine and 4 mg Dexamethasone; Group 4: 25 ml of 0.25% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65 years with ASA I-II who will undergo surgery on the hand, wrist, forearm, or elbow.

You may not qualify if:

• Patient refusal to undergo the procedure
• ASA III or higher status
• Diagnosis of diabetes mellitus
• Pregnancy
• History of multiple trauma
• Patients with communication difficulties during or after the procedure
• Sensory impairment at the site of regional anesthesia application
• Presence of a neuromuscular disease
• Open wound or infection at the site of block application
• Coagulopathy that contraindicates the block
• History of allergy to the drugs to be used

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

Related Publications (3)

• Gupta PK, Hopkins PM. Effect of concentration of local anaesthetic solution on the ED(5)(0) of bupivacaine for supraclavicular brachial plexus block. Br J Anaesth. 2013 Aug;111(2):293-6. doi: 10.1093/bja/aet033. Epub 2013 Mar 26.

  PMID: 23533252 BACKGROUND

• Liu J, Richman KA, Grodofsky SR, Bhatt S, Huffman GR, Kelly JD 4th, Glaser DL, Elkassabany N. Is there a dose response of dexamethasone as adjuvant for supraclavicular brachial plexus nerve block? A prospective randomized double-blinded clinical study. J Clin Anesth. 2015 May;27(3):237-42. doi: 10.1016/j.jclinane.2014.12.004. Epub 2015 Jan 28.

  PMID: 25637938 BACKGROUND

• Alarasan AK, Agrawal J, Choudhary B, Melhotra A, Uike S, Mukherji A. Effect of dexamethasone in low volume supraclavicular brachial plexus block: A double-blinded randomized clinical study. J Anaesthesiol Clin Pharmacol. 2016 Apr-Jun;32(2):234-9. doi: 10.4103/0970-9185.182108.

  PMID: 27275056 BACKGROUND

Study Officials

• Dondu Genc Moralar, Assoc. Prof.

  Gaziosmanpasa Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: January 2, 2024
• Primary Completion: August 1, 2024
• Study Completion: February 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

TU (1)