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NCT06027918

The Effect of Altitude Difference on the Duration of Nerve Block; A Three-Center Study.

Completed NA Last updated 23 May 2024
What this trial tests

NA trial testing Infraclavicular brachial plexus block in Forearm Surgery in 159 participants. Completed in 16 April 2024.

Timeline
3 October 2023
Primary endpoint
15 April 2024
16 April 2024

Quick facts

Lead sponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment159
Start date3 October 2023
Primary completion15 April 2024
Estimated completion16 April 2024
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Who can join

Adults 18 to 55, any sex, with Forearm Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Infraclavicular brachial plexus block in hand and forearm surgery has the advantages of high success rate and low risk of complications and is useful in providing long-lasting and effective postoperative analgesia in these patients. In response to hypoxemia at high altitude, increased blood viscosity, decreased carbon monoxide diffusion capacity, increased cerebral arterial blood flow, decreased blood volume and decreased cardiac output occur. At high altitude, the serum level of local anesthetics may increase due to an increase in their ionized fraction and a decrease in their clearance. In this respect, the pharmacodynamic and pharmacokinetic properties of peripheral nerve blocks may be altered when performed at high altitude. The primary objective of this prospective study was to test the hypothesis that postoperative pain scores are higher in patients undergoing infraclavicular nerve block at high altitude than in patients at low altitude. This multicenter prospective randomized study will be initiated after approval of the Ethics Committee of Health ScienceUniversity Diyarbakir Gazi Yasargil Training and Research Hospital. Patients will be recruited simultaneously in 3 hospitals, Hatay Training and Research Hospital, Hatay, Turkey (100 m above sea level);Health Science Health Science University Diyarbakir Gazi Yasargil Training and Research Hospital, Diyarbakir, Turkey (675 m above sea level) and Health Science University Van Regional and Training Research Hospital, Van, Turkey (1726 m above sea level). Infraclavicular brachial plexus blocks (coracoid approach) will be performed by administering a local anesthetic mixture of 1.5 mg/kg lidocaine 2% + 1 mg/kg bupivacaine 0.5% at the 6 o'clock position of the axillary artery under US guidance.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Infraclavicular brachial plexus block

Trials testing the same drug.

Other recruiting trials for Forearm Surgery

Currently open trials in the same condition.

Other Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital trials

Trials by the same sponsor.

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Data sources for this page

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