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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.
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 0.5% bupivacaine only | Active Comparator | Group 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 | Group 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 | "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 | Group 4: 25 ml of 0.25% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infraclavicular Brachial Plexus Blocks | Procedure | Lateral sagittal technique infraclavicular brachial plexus block |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Block Onset Time | The secondary outcome of this study is the onset time of infraclavicular brachial plexus block. | 30 minutes |
| Postoperative pain levels | Evaluating the postoperative pain levels in patients. Pain levels will be assessed using the Visual Analog Scale (VAS). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dondu Genc Moralar, Assoc. Prof. | Gaziosmanpasa Training and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziosmanpasa Training and Research Hospital | Istanbul | 34255 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23533252 | Result | 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. | |
| 25637938 | Result | Liu 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. |
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| 48 hours |
| Total analgesic requirements | Evaluating the total analgesic requirements during the first 48 hours postoperatively. | 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. | 30 minutes |
| 27275056 | Result | Alarasan 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. |