Active — Not RecruitingNot Applicable

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

Turkey (Türkiye)120 participantsStarted 2024-01-02

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 18-65 years with ASA I-II who will undergo surgery on the hand, wrist, forearm, or elbow. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of motor and sensory block

Timeframe: 48 hours

Trial details

NCT IDNCT06769581

SponsorGaziosmanpasa Research and Education Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-08-01

View on ClinicalTrials.gov More Infraclavicular Brachial Plexus Block trials