Infraclavicular Brachial Plexus Block With Bupivacaine Alone or With Both Dexmedetomidine and Dexamethasone

NCT ID: NCT06356415

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-09-30

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.

Conditions

Upper Extremity Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine injection

Intervention Type: DRUG

Group one will receive infraclavicular block using bupivacaine

Bupivacaine+ Dexamethasone+ Dexmedetomidine

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine+ Dexamethasone+ Dexmedetomidine

Intervention Type: DRUG

Group two will receive infraclavicular block using dexamethasone and dexmedetomidine added to the bupivacaine

Interventions

Bupivacaine injection

Group one will receive infraclavicular block using bupivacaine

Intervention Type: DRUG

Bupivacaine+ Dexamethasone+ Dexmedetomidine

Group two will receive infraclavicular block using dexamethasone and dexmedetomidine added to the bupivacaine

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrhman Alshawadfy

Assistant Professor Suez Canal University Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Dex Dex in infraclavicular

Identifier Type: -

Identifier Source: org_study_id