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Clinical Trials/NCT06356415
NCT06356415
Not yet recruiting
Not Applicable

Infraclavicular Brachial Plexus Block Using Bupivacaine Alone or in Combination With Dexmedetomidine and Dexamethasone for Hand and Forearm Surgeries, A Randomized, Controlled Trial

Suez Canal University0 sites40 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Bupivacaine injection
Conditions
Upper Extremity Injury
Sponsor
Suez Canal University
Enrollment
40
Primary Endpoint
Onset of sensory block
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

Upper-extremity regional anesthetic techniques, using brachial plexus blockade, have been shown to reduce adverse effects related to opioid administration, improve patient satisfaction, and provide significantly improved analgesia immediately following these surgeries. Many medications have been investigated to extend and enhance long-acting local anesthetics' (LA) analgesic effects. Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal long-lasting single-shot nerve block. In general, adjuvants have been used in peripheral nerve blocks to accelerate onset, decrease plasmatic absorption and secondary toxic effects, and prolong the block effects.

Detailed Description

Brachial plexus blockade-based upper-extremity regional anesthetic approaches have been demonstrated to lessen opioid administration side effects, increase patient satisfaction, and offer noticeably better analgesia right after these surgeries. A lot of drugs have been tested to prolong and improve the analgesic effect of long-acting local anesthetics (LA). Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal, long-lasting single-shot nerve block. Adjuvants have generally been employed in peripheral nerve blocks to lengthen the block effects, limit secondary toxic effects and plasmatic absorption, and speed the onset of the block. Objectives: To compare the effects of adding dexmedetomidine and dexamethasone to bupivacaine on the start of sensory blockade in an infraclavicular brachial plexus block. Patients and Methods: A prospective, randomized controlled trial will be conducted on patients who are undergoing hand or forearm surgeries. Patients who will be eligible for the study will be divided into 2 groups. The first group will receive dexmedetomidine and dexamethasone as adjuvants to bupivacaine, while the second group will receive bupivacaine alone. Expected Results: The success rate, onset time, duration of the block, and possible adverse events.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
September 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abdelrhman Alshawadfy

Assistant Professor Suez Canal University Faculty of Medicine

Suez Canal University

Eligibility Criteria

Inclusion Criteria

  • Age 18-65 years
  • American Society of Anesthesiologists physical status I-II
  • Body mass index between 18 and 35 kg/ m2
  • scheduled for forearm and hand surgeries

Exclusion Criteria

  • Inability to consent to the study
  • Coagulopathy
  • Decompensated chronic hepatic or renal illnesses
  • Allergy to any of the used drugs
  • Pre-existing musculocutaneous/median/radial/ ulnar neuropathy
  • Prior surgery in the infraclavicular fossa

Arms & Interventions

Bupivacaine

Patients will undergo an ultrasound-guided infraclavicular brachial plexus block using bupivacaine alone.

Intervention: Bupivacaine injection

Bupivacaine+ Dexamethasone+ Dexmedetomidine

Patients will undergo an ultrasound-guided infraclavicular brachial plexus block using bupivacaine combined with dexmedetomidine and dexamethasone.

Intervention: Bupivacaine+ Dexamethasone+ Dexmedetomidine

Outcomes

Primary Outcomes

Onset of sensory block

Time Frame: Immediately after the performance of the infraclavicular block

Comparing the number of minutes required to achieve total upper limb sensory blockade following the application of an infraclavicular brachial plexus block that includes both dexmedetomidine and dexamethasone in addition to bupivacaine, as opposed to merely using bupivacaine on its own.

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