Clinical trial NCT06356415: Infraclavicular Brachial Plexus Block With Bupivacaine Alone or With Both Dexmedetomidine and Dexamethasone
Official title: Infraclavicular Brachial Plexus Block Using Bupivacaine Alone or in Combination With Dexmedetomidine and Dexamethasone for Hand and Forearm Surgeries, A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Upper Extremity Injury
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Sepsis
* 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

Primary outcomes:
measure: Onset of sensory block
timeFrame: Immediately after the performance of the infraclavicular block
Secondary outcomes:
Other outcomes:
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