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Recruiting Not applicable

Impact of Bupivacaine Dilution With Dextrose or Saline on Infraclavicular Block Outcomes

NCT07386327 · tracked via the Priya Life Science Turkey tracker
Sponsor
Burçin Alaçam, MD
Phase
Not applicable
Started
2026-03-09
Last updated
2026-06-23

Condition(s) studied

Infraclavicular Brachial Plexus BlockDextroseBupivacaineBlock SuccessPostoperative Analgesia

Investigational drug(s) / intervention(s)

Blocked and analgesia time

Blocked and analgesia time: All eligible participants will be informed in detail about the study objectives, procedures, potential risks, and benefits by the responsible investigator, and all questions will be answered prior to enrollment. Written informed consent will be obtained from each participant before any study-related procedures are initiated. Following the ultrasound-guided infraclavicular block, sensory block assessment will be performed using a sterile single-use needle for a pinprick test. Light punctate stimuli will be applied to dermatomal areas corresponding to the branches of the brachial plexus on the blocked extremity. Participants will be asked to compare the sensation with the contralateral limb and to report the perceived sensation as "normal," "reduced," or "absent." Sensory block assessments will be performed at 5, 10, 15, 20, and 30 minutes after block administration. Sensory block onset time will be defined as the time point at which the participant reports absence of pinprick sensation

Study summary

D5W) has long been used as an intravenous fluid for hydration and energy supplementation and has recently gained increasing clinical interest in perineural injection therapies and ultrasound-guided hydrodissection. D5W has been shown to improve pain and functional outcomes in entrapment neuropathies by mechanically releasing perineural adhesions and potentially modulating neurogenic inflammation. In contrast, 0.9% sodium chloride (normal saline) is routinely used as a dilution medium for local anesthetics in peripheral nerve blocks; however, emerging evidence suggests that alternative diluents such as D5W may influence block onset and efficacy.

The infraclavicular block is a commonly used ultrasound-guided technique for brachial plexus anesthesia, providing reliable anesthesia and postoperative analgesia for upper extremity surgery. This study aims to compare the effects of diluting bupivacaine with either D5W or 0.9% NaCl on block success and duration of analgesia in patients undergoing infraclavicular block. Secondary outcomes include block onset characteristics, sensory and motor block profiles, and perioperative analgesic requirements. The findings may help determine whether D5W represents a safe and effective alternative diluent to saline in routine regional anesthesia practice.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Patients who agree to participate in the study and provide written informed consent * Patients scheduled for elective upper extremity surgery for whom infraclavicular block is considered appropriate for anesthetic management * Age between 18 and 65 years * American Society of Anesthesiologists (ASA) physical status I-III * Patients with a normal neurological examination in the extremity scheduled for peripheral nerve block Exclusion Criteria: * Patients who decline to participate in the study or refuse to provide informed consent * History of allergy or hypersensitivity to study medications * Body mass index (BMI) ≥ 30 kg/m² * Body weight less than 40 kg * Age below 18 years or above 65 years * History of significant cardiac disease (e.g., arrhythmia, conduction disorders) * Presence of coagulopathy (international normalized ratio \[INR\] \> 1.5 and/or platelet count \< 100,000/mm³) * Hepatic failure or significant liver dysfunction * Pregnant patients * Infection at the planned peripheral block site * Presence of neurological deficit in the extremity planned for peripheral nerve block * Patients with uncontrolled diabetes mellitus and/or established diabetic neuropathy * American Society of Anesthesiologists (ASA) physical status IV

Primary outcome measure(s)

  • Sensory block onset time — Assessed at 5, 10, 15, 20, and 30 minutes after block administration.
    Sensory block onset time will be defined as the time from completion of the ultrasound-guided infraclavicular block until the participant reports complete loss of pinprick sensation in the dermatomal areas corresponding to the branches of the brachial plexus, assessed using a sterile pinprick test.

Trial sites (1)

FacilityCityRegionStatus
Sakarya University-Anesthesiology and Reanimation Department Sakarya Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07386327 on ClinicalTrials.gov ↗ ← All trials in Turkey