Infraclavicular Brachial Plexus BlockNCT06769581
The Effect of Dexamethasone Adjuvant to Varying Doses of Bupivacaine on Motor and Sensory Blockade in Infraclavicular Brachial Plexus Blockade
A study testing Infraclavicular Brachial Plexus Blocks in people with Infraclavicular Brachial Plexus Block and Dexamethasone Administration, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Infraclavicular Brachial Plexus Block, Dexamethasone Administration, Bupivacaine
- What is being tested?
- Infraclavicular Brachial Plexus Blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 aged 18-65 years with ASA I-II who will undergo surgery on the hand, wrist, forearm, or elbow.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul, 34255
About this study
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.
Read the detailed description
This study investigates whether adding dexamethasone, a commonly used steroid, to different strengths of bupivacaine (a local anesthetic) can improve the effectiveness and duration of nerve blocks used for upper limb surgeries. The nerve block in this study is an infraclavicular brachial plexus block, which numbs the arm and hand by targeting specific nerves near the shoulder. This type of anesthesia is often preferred for surgeries of the hand, wrist, forearm, or elbow because it reduces pain and the need for general anesthesia.
What Is Being Studied? The research focuses on four groups of patients receiving different mixtures of bupivacaine, with or without dexamethasone. Each patient will receive the same volume of anesthetic solution (25 mL) through a standardized procedure performed under ultrasound and nerve stimulator guidance.
- Group 1: 0.5% bupivacaine only.
- Group 2: 0.5% bupivacaine with 4 mg dexamethasone.
- Group 3: 0.375% bupivacaine with 4 mg dexamethasone.
- Group 4: 0.25% bupivacaine with 4 mg dexamethasone. Why Is This Important? Local anesthetics like bupivacaine can effectively block pain, but using higher concentrations may carry risks, such as muscle weakness or local anesthetic toxicity. Combining dexamethasone with lower concentrations of bupivacaine might extend the block's duration and effectiveness, potentially reducing the total amount of anesthetic needed. This could improve patient safety and recovery while maintaining excellent pain control.
How Will It Be Done? The study involves 120 adult patients aged 18-65, all undergoing elective upper limb surgeries. Participants will be randomly assigned to one of the four groups, and both the patients and the doctors evaluating their progress will not know which group they are in.
Before surgery, each patient will receive the nerve block. The anesthetic solution will be injected near the shoulder, targeting specific nerves with the help of ultrasound and a nerve stimulator. Researchers will measure:
- How quickly the block starts working (block onset time).
- How long the block lasts (motor and sensory block duration).
- The level of pain experienced after surgery, using a pain scale.
- The total amount of pain medication needed within the first 48 hours. What Happens After Surgery? Patients will be closely monitored for pain and block effectiveness. If a patient experiences significant pain during surgery due to an incomplete block, additional anesthetic may be given to the specific nerve, or general anesthesia may be initiated if necessary. Postoperatively, pain relief will be managed with standard medications, and the timing and total dosage will be recorded.
Study Goals:
The primary goal is to determine whether dexamethasone can enhance the duration and effectiveness of the block across different bupivacaine strengths. Secondary goals include understanding how dexamethasone affects block onset time, postoperative pain, and the need for additional pain medications.
Broader Implications:
The findings could help refine anesthesia techniques, making nerve blocks safer and more effective. If lower concentrations of bupivacaine combined with dexamethasone provide similar or better results than higher concentrations alone, this could reduce the risks associated with local anesthetics and improve patient recovery experiences.
This research has the potential to guide future anesthesia practices, benefiting both patients and clinicians by optimizing drug combinations for nerve blocks.
- Being tested
- Infraclavicular Brachial Plexus Blocks
- Keywords
- infraclavicular brachial plexus block, dexamethasone, bupivacaine, concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular Brachial Plexus BlocksProcedure or surgery
Lateral sagittal technique infraclavicular brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 0.5% bupivacaine only | Active comparator | Group 1: 25 ml of 0.5% bupivacaine for infraclavicular brachial plexus block Receives: Procedure: Infraclavicular Brachial Plexus Blocks |
| Group 2: 25 ml of 0.5% Bupivacaine and 4 mg Dexamethasone | Experimental | Group 2: 25 ml of 0.5% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block Receives: Procedure: Infraclavicular Brachial Plexus Blocks |
| Group 3: 25 ml of 0.375% Bupivacaine and 4 mg Dexamethasone | Experimental | "Group 3: 25 ml of 0.375% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block. Receives: Procedure: Infraclavicular Brachial Plexus Blocks |
| Group 4: 25 ml of 0.25% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution | Experimental | Group 4: 25 ml of 0.25% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block. Receives: Procedure: Infraclavicular Brachial Plexus Blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of motor and sensory block
The primary outcome of this study is to examine the effects of different concentrations of bupivacaine combined with dexamethasone, in the same volume, on the duration of motor block and sensory block during infraclavicular brachial plexus block.
Measured: 48 hours
Secondary outcomes (4)
Block Onset Time
The secondary outcome of this study is the onset time of infraclavicular brachial plexus block.
Measured: 30 minutes
Postoperative pain levels
Evaluating the postoperative pain levels in patients. Pain levels will be assessed using the Visual Analog Scale (VAS).
Measured: 48 hours
Total analgesic requirements
Evaluating the total analgesic requirements during the first 48 hours postoperatively.
Measured: 48 hours
Block Failure
Comparing the rates of rescue blocks and the incidence of conversion to general anesthesia following the administration of infraclavicular brachial plexus block.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start2 Jan 2024
- Primary completion1 Aug 2024
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Döndü Genc Moralar, Gaziosmanpasa Research and Education Hospital
- Investigators
- Dondu Genc Moralar, Assoc. Prof., Study director, Gaziosmanpasa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769581
- Sponsor's protocol ID
- 159
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gupta PK, Hopkins PM. Effect of concentration of local anaesthetic solution on the ED(5)(0) of bupivacaine for supraclavicular brachial plexus block. Br J Anaesth. 2013 Aug;111(2):293-6. doi: 10.1093/bja/aet033. Epub 2013 Mar 26.
PubMed 23533252Liu J, Richman KA, Grodofsky SR, Bhatt S, Huffman GR, Kelly JD 4th, Glaser DL, Elkassabany N. Is there a dose response of dexamethasone as adjuvant for supraclavicular brachial plexus nerve block? A prospective randomized double-blinded clinical study. J Clin Anesth. 2015 May;27(3):237-42. doi: 10.1016/j.jclinane.2014.12.004. Epub 2015 Jan 28.
PubMed 25637938Alarasan AK, Agrawal J, Choudhary B, Melhotra A, Uike S, Mukherji A. Effect of dexamethasone in low volume supraclavicular brachial plexus block: A double-blinded randomized clinical study. J Anaesthesiol Clin Pharmacol. 2016 Apr-Jun;32(2):234-9. doi: 10.4103/0970-9185.182108.
PubMed 27275056
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone Adjuvant to Varying Doses of Bupivacaine on Motor and Sensory Blockade in Infraclavicular Brachial Plexus Blockade
- ClinicalTrials.gov ID
- NCT06769581
- Acronym / sponsor ID
- 159
- Keywords
- infraclavicular brachial plexus block, dexamethasone, bupivacaine, concentration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 10 Jan 2025 (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.
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.
Detailed description
This study investigates whether adding dexamethasone, a commonly used steroid, to different strengths of bupivacaine (a local anesthetic) can improve the effectiveness and duration of nerve blocks used for upper limb surgeries. The nerve block in this study is an infraclavicular brachial plexus block, which numbs the arm and hand by targeting specific nerves near the shoulder. This type of anesthesia is often preferred for surgeries of the hand, wrist, forearm, or elbow because it reduces pain and the need for general anesthesia.
What Is Being Studied? The research focuses on four groups of patients receiving different mixtures of bupivacaine, with or without dexamethasone. Each patient will receive the same volume of anesthetic solution (25 mL) through a standardized procedure performed under ultrasound and nerve stimulator guidance.
- Group 1: 0.5% bupivacaine only.
- Group 2: 0.5% bupivacaine with 4 mg dexamethasone.
- Group 3: 0.375% bupivacaine with 4 mg dexamethasone.
- Group 4: 0.25% bupivacaine with 4 mg dexamethasone. Why Is This Important? Local anesthetics like bupivacaine can effectively block pain, but using higher concentrations may carry risks, such as muscle weakness or local anesthetic toxicity. Combining dexamethasone with lower concentrations of bupivacaine might extend the block's duration and effectiveness, potentially reducing the total amount of anesthetic needed. This could improve patient safety and recovery while maintaining excellent pain control.
How Will It Be Done? The study involves 120 adult patients aged 18-65, all undergoing elective upper limb surgeries. Participants will be randomly assigned to one of the four groups, and both the patients and the doctors evaluating their progress will not know which group they are in.
Before surgery, each patient will receive the nerve block. The anesthetic solution will be injected near the shoulder, targeting specific nerves with the help of ultrasound and a nerve stimulator. Researchers will measure:
- How quickly the block starts working (block onset time).
- How long the block lasts (motor and sensory block duration).
- The level of pain experienced after surgery, using a pain scale.
- The total amount of pain medication needed within the first 48 hours. What Happens After Surgery? Patients will be closely monitored for pain and block effectiveness. If a patient experiences significant pain during surgery due to an incomplete block, additional anesthetic may be given to the specific nerve, or general anesthesia may be initiated if necessary. Postoperatively, pain relief will be managed with standard medications, and the timing and total dosage will be recorded.
Study Goals:
The primary goal is to determine whether dexamethasone can enhance the duration and effectiveness of the block across different bupivacaine strengths. Secondary goals include understanding how dexamethasone affects block onset time, postoperative pain, and the need for additional pain medications.
Broader Implications:
The findings could help refine anesthesia techniques, making nerve blocks safer and more effective. If lower concentrations of bupivacaine combined with dexamethasone provide similar or better results than higher concentrations alone, this could reduce the risks associated with local anesthetics and improve patient recovery experiences.
This research has the potential to guide future anesthesia practices, benefiting both patients and clinicians by optimizing drug combinations for nerve blocks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: 0.5% bupivacaine only | Active comparator | Procedure: Infraclavicular Brachial Plexus BlocksGroup 1: 25 ml of 0.5% bupivacaine for infraclavicular brachial plexus block |
| Group 2: 25 ml of 0.5% Bupivacaine and 4 mg Dexamethasone | Experimental | Procedure: Infraclavicular Brachial Plexus BlocksGroup 2: 25 ml of 0.5% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block |
| Group 3: 25 ml of 0.375% Bupivacaine and 4 mg Dexamethasone | Experimental | Procedure: Infraclavicular Brachial Plexus Blocks"Group 3: 25 ml of 0.375% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block. |
| Group 4: 25 ml of 0.25% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution | Experimental | Procedure: Infraclavicular Brachial Plexus BlocksGroup 4: 25 ml of 0.25% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-65 years with ASA I-II who will undergo surgery on the hand, wrist, forearm, or elbow.
Key exclusion criteria (11 listed)
- Patient refusal to undergo the procedure
- ASA III or higher status
- Diagnosis of diabetes mellitus
- Pregnancy
- History of multiple trauma
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 |
|---|---|---|
| Infraclavicular Brachial Plexus BlocksLateral sagittal technique infraclavicular brachial plexus block | Procedure or surgery | Group 1: 0.5% bupivacaine only, Group 2: 25 ml of 0.5% Bupivacaine and 4 mg Dexamethasone, Group 3: 25 ml of 0.375% Bupivacaine and 4 mg Dexamethasone, Group 4: 25 ml of 0.25% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution |
Primary outcome
Duration of motor and sensory block
Time frame: 48 hours
The primary outcome of this study is to examine the effects of different concentrations of bupivacaine combined with dexamethasone, in the same volume, on the duration of motor block and sensory block during infraclavicular brachial plexus block.
4 secondary outcomes
Block Onset Time
Time frame: 30 minutes
Postoperative pain levels
Time frame: 48 hours
Total analgesic requirements
Time frame: 48 hours
Block Failure
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Results publication: PubMed 23533252Gupta PK, Hopkins PM. Effect of concentration of local anaesthetic solution on the ED(5)(0) of bupivacaine for supraclavicular brachial plexus block. Br J Anaesth. 2013 Aug;111(2):293-6. doi: 10.1093/bja/aet033. Epub 2013 Mar 26.
- Results publication: PubMed 25637938Liu J, Richman KA, Grodofsky SR, Bhatt S, Huffman GR, Kelly JD 4th, Glaser DL, Elkassabany N. Is there a dose response of dexamethasone as adjuvant for supraclavicular brachial plexus nerve block? A prospective randomized double-blinded clinical study. J Clin Anesth. 2015 May;27(3):237-42. doi: 10.1016/j.jclinane.2014.12.004. Epub 2015 Jan 28.
- Results publication: PubMed 27275056Alarasan AK, Agrawal J, Choudhary B, Melhotra A, Uike S, Mukherji A. Effect of dexamethasone in low volume supraclavicular brachial plexus block: A double-blinded randomized clinical study. J Anaesthesiol Clin Pharmacol. 2016 Apr-Jun;32(2):234-9. doi: 10.4103/0970-9185.182108.
- Individual participant dataSharing planned: Undecided
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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.
Dondu Genc Moralar, Assoc. Prof. study director
Gaziosmanpasa Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraclavicular Brachial Plexus Blocks in people with Infraclavicular Brachial Plexus Block and Dexamethasone Administration, run by Gaziosmanpasa Research and Education Hospital 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 1 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Duration of motor and sensory block (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06769581, which also lists 3 linked publications.
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 10 Jan 2025.