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

NCT07386327 | Recruiting

• 1 other identifier: SAU-ANE-BA-03
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infraclavicular Brachial Plexus Block; Dextrose; Bupivacaine; Block Success; Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Sensory block onset time

  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.

  Assessed at 5, 10, 15, 20, and 30 minutes after block administration.

Secondary Outcomes (3)

• Motor block duration

  From block performance until complete motor recovery (up to 24 hours postoperatively).

• Intraoperative need for additional anesthetic or analgesic intervention

  During the intraoperative period.

• Postoperative analgesic efficacy

  Postoperative 2, 6, 12, and 24 hours.

Study Arms (2)

Group D

EXPERIMENTAL

Participants in this group will receive an ultrasound-guided infraclavicular brachial plexus block using bupivacaine diluted in a 1:1 ratio with 5% dextrose in water (D5W) to achieve a predetermined total injection volume (e.g., total volume of 30 mL). The block will be performed under standardized aseptic conditions by an experienced anesthesiologist. Block success, sensory and motor block characteristics, duration of analgesia, and postoperative analgesic requirements will be assessed and recorded.

Diagnostic Test: Blocked and analgesia time

Group S

EXPERIMENTAL

Participants in this group will receive an ultrasound-guided infraclavicular brachial plexus block using bupivacaine diluted in a 1:1 ratio with 0.9% sodium chloride (normal saline) to achieve a predetermined total injection volume (e.g., total volume of 30 mL). The block will be performed under standardized aseptic conditions by an experienced anesthesiologist. Block success, sensory and motor block characteristics, duration of analgesia, and postoperative analgesic requirements will be assessed and recorded.

Diagnostic Test: Blocked and analgesia time

Interventions

Blocked and analgesia time DIAGNOSTIC_TEST

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

Group D; Group S

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Burçin Alaçam, MD: lead

Study Sites (1)

Sakarya University-Anesthesiology and Reanimation Department

Sakarya, 54100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Burçin Alaçam

CONTACT

+905465903851; burcin.ersoy90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist performing the block will be aware of the study solution due to preparation requirements. Patients, outcome assessors, and data analysts will be blinded to group allocation to minimize assessment and analysis bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology Specialist

Model Details: Participants will be randomly assigned to one of two parallel groups. In the first group, bupivacaine will be diluted with 5% dextrose in water (D5W), and in the second group, bupivacaine will be diluted with 0.9% sodium chloride (normal saline). All patients will undergo ultrasound-guided infraclavicular brachial plexus block using the assigned study solution. Block success, duration of analgesia, and secondary block characteristics will be compared between the two groups.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)