Infraclavicular Brachial Plexus BlockNCT07386327
Impact of Bupivacaine Dilution With Dextrose or Saline on Infraclavicular Block Outcomes
A study testing Blocked and analgesia time in people with Infraclavicular Brachial Plexus Block and Dextrose, run by Burçin Alaçam, MD at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Infraclavicular Brachial Plexus Block, Dextrose, Bupivacaine
- What is being tested?
- Blocked and analgesia time
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2026to 26 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University-Anesthesiology and Reanimation Department
Sakarya, 54100
About this study
Official title: The Effect of Diluting Bupivacaine With 5% Dextrose and 0.9% NaCl on Block Success and Duration of Analgesia in Infraclavicular Block
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.
Read the detailed description
D5W) has traditionally been used as an intravenous fluid to provide hydration and caloric support. In recent years, D5W has gained increasing attention for its use in innovative perineural injection therapies and ultrasound-guided hydrodissection techniques, particularly in the management of peripheral nerve entrapment syndromes. Clinical and randomized controlled studies have demonstrated that perineural D5W hydrodissection can mechanically separate fibrotic tissues surrounding compressed nerves, improve perineural blood flow, reduce pain, and enhance sensory and functional recovery in conditions such as carpal tunnel syndrome and meralgia paresthetica. Beyond its mechanical effects, D5W is also thought to modulate neurogenic inflammation, regulate nociceptive C-fiber activity through local glucose-related mechanisms, and potentially promote neuroregenerative processes.
In routine regional anesthesia practice, 0.9% sodium chloride (normal saline) is the most commonly used diluent for local anesthetics to achieve the desired volume and concentration for peripheral nerve blocks. However, experimental and clinical data suggest that the sodium content and physicochemical properties of saline may influence the onset and quality of neural blockade. Some studies have reported earlier sensory block onset when local anesthetics are diluted with D5W rather than saline, suggesting that the choice of diluent may affect block characteristics.
The infraclavicular brachial plexus block is a well-established ultrasound-guided technique that provides reliable anesthesia and postoperative analgesia for surgeries involving the mid and distal upper extremity. Visualization of neural structures allows optimized local anesthetic spread and consistent block performance in routine clinical practice.
This study is designed to evaluate the effect of diluting bupivacaine with either D5W or 0.9% NaCl on block success and duration of analgesia in patients undergoing ultrasound-guided infraclavicular block. Secondary outcomes will include onset time of sensory and motor block, block quality, postoperative analgesic consumption, and safety parameters. By investigating an alternative dilution strategy, this study aims to contribute to optimizing peripheral nerve block techniques and improving patient-centered clinical outcomes.
- Conditions
- Infraclavicular Brachial Plexus Block, Dextrose, Bupivacaine, Block Success, Postoperative Analgesia
- Being tested
- Blocked and analgesia time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blocked and analgesia timeDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Blocked and analgesia time |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at 5, 10, 15, 20, and 30 minutes after block administration.
Secondary outcomes (3)
Motor block duration
Motor block duration will be defined as the time from onset of motor block (Modified Upper Extremity Bromage Scale ≥1) until full recovery to Bromage score 0.
Measured: From block performance until complete motor recovery (up to 24 hours postoperatively).
Intraoperative need for additional anesthetic or analgesic intervention
Requirement for supplemental anesthetic or analgesic interventions during surgery will be recorded as a binary outcome (yes/no) and as total additional drug consumption if applicable.
Measured: During the intraoperative period.
Postoperative analgesic efficacy
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst imaginable pain) at postoperative 2, 6, 12, and 24 hours.
Measured: Postoperative 2, 6, 12, and 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start9 Mar 2026
- Primary completion15 Jun 2026
- Study completion26 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infraclavicular Brachial Plexus BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burçin Alaçam, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burçin Alaçam, MD, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386327
- Sponsor's protocol ID
- SAU-ANE-BA-03
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diluting Bupivacaine With 5% Dextrose and 0.9% NaCl on Block Success and Duration of Analgesia in Infraclavicular Block
- ClinicalTrials.gov ID
- NCT07386327
- Acronym / sponsor ID
- SAU-ANE-BA-03
- Conditions
- Infraclavicular Brachial Plexus Block, Dextrose, Bupivacaine, Block Success, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Burçin Alaçam, MDUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 26 Oct 2026 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
D5W) has traditionally been used as an intravenous fluid to provide hydration and caloric support. In recent years, D5W has gained increasing attention for its use in innovative perineural injection therapies and ultrasound-guided hydrodissection techniques, particularly in the management of peripheral nerve entrapment syndromes. Clinical and randomized controlled studies have demonstrated that perineural D5W hydrodissection can mechanically separate fibrotic tissues surrounding compressed nerves, improve perineural blood flow, reduce pain, and enhance sensory and functional recovery in conditions such as carpal tunnel syndrome and meralgia paresthetica. Beyond its mechanical effects, D5W is also thought to modulate neurogenic inflammation, regulate nociceptive C-fiber activity through local glucose-related mechanisms, and potentially promote neuroregenerative processes.
In routine regional anesthesia practice, 0.9% sodium chloride (normal saline) is the most commonly used diluent for local anesthetics to achieve the desired volume and concentration for peripheral nerve blocks. However, experimental and clinical data suggest that the sodium content and physicochemical properties of saline may influence the onset and quality of neural blockade. Some studies have reported earlier sensory block onset when local anesthetics are diluted with D5W rather than saline, suggesting that the choice of diluent may affect block characteristics.
The infraclavicular brachial plexus block is a well-established ultrasound-guided technique that provides reliable anesthesia and postoperative analgesia for surgeries involving the mid and distal upper extremity. Visualization of neural structures allows optimized local anesthetic spread and consistent block performance in routine clinical practice.
This study is designed to evaluate the effect of diluting bupivacaine with either D5W or 0.9% NaCl on block success and duration of analgesia in patients undergoing ultrasound-guided infraclavicular block. Secondary outcomes will include onset time of sensory and motor block, block quality, postoperative analgesic consumption, and safety parameters. By investigating an alternative dilution strategy, this study aims to contribute to optimizing peripheral nerve block techniques and improving patient-centered clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group D | Experimental | Diagnostic Test: Blocked and analgesia timeParticipants 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. |
| Group S | Experimental | Diagnostic Test: Blocked and analgesia timeParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blocked and analgesia timeAll 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 | Diagnostic test | Group D, Group S |
Primary outcome
Sensory block onset time
Time frame: 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.
3 secondary outcomes
Motor block duration
Time frame: From block performance until complete motor recovery (up to 24 hours postoperatively).
Intraoperative need for additional anesthetic or analgesic intervention
Time frame: During the intraoperative period.
Postoperative analgesic efficacy
Time frame: Postoperative 2, 6, 12, and 24 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blocked and analgesia time in people with Infraclavicular Brachial Plexus Block and Dextrose, run by Burçin Alaçam, MD at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory block onset time (time frame: Assessed at 5, 10, 15, 20, and 30 minutes after block administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.