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Midazolam in Supraclavicular Brachial Plexus Block

NCT03185351 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-09-24

No results posted yet for this study

Summary

An effective brachial plexus block (BPB) provides a useful alternative to general anesthesia for upper arm surgery producing complete muscular relaxation. It provides surgical anesthesia in upper extremity surgery, post-operative analgesia and chronic pain management. In addition to surgical procedure on conscious patients and early eating after the procedure make regional anesthesia more attractive.

Brachial plexus block also maintains stable intraoperative hemodynamic and associated sympathetic block. The sympathetic block decreases postoperative pain, vasospasm and edema. The nerve of brachial plexus may be blocked anywhere along its course. The approach for blocking brachial plexus nerve is interscalene, supraclavicular, infraclavicular and axillary approach.

Supraclavicular approach for blockade of the brachial plexus is the most commonly used approach in providing surgical anesthesia. In recent years, the technique has gained importance as regional anesthetic technique for surgical, diagnostic and therapeutic purposes in interventional pain management. It includes blocking of the brachial plexus where it is most compactly arranged, with fewer requirements of the anesthetic solution and rapid onset of action. Supraclavicular nerve block is technically easy to perform because of reliable and fixed landmark but association of pneumothorax is a profound complication.

The extent of blockade following injection into the sheath surrounding the brachial plexus may depend on the volume and concentration of local anesthetic (LA) used. Because of bupivacaine long duration of action, it is used most frequently among local anesthetics for BPB.

Inevitably, the effects of single-injection BPB dissipate after several hours unmasking the moderate-to-severe pain of the surgical insult. Efforts to prolong BPB duration by increasing LA dose are limited by their narrow therapeutic window and indeed may not be effective as recent studies have demonstrated equivalent analgesic duration with volumes as low as 5 ml.

Midazolam is known to produce antinociception and potentiate the effect of LA when given in neuraxial block. It produces this effect by its action on Gamma Aminobutyric Acid-A (GABA-A) receptors and also on the peripheral nerves which contain these receptors.

Several studies showed midazolam to be effective when used in intrathecal, epidural and caudal blocks and now recently midazolam with bupivacaine has been found to improve analgesic characteristics in peripheral blocks compared to bupivacaine alone. Due to the high blood concentration of benzodiazepine through conventional routes and profound sedation, proper assessment of analgesic effect was difficult to obtain. With the advent of the less toxic water soluble benzodiazepine (midazolam), it became possible to use it directly over the nerve tissues.

Conditions

  • Forearm Surgeries

Interventions

DRUG

Bupivacaine

20 ml of 0.5% bupivacaine using supraclavicular BPB.

DRUG

Midazolam

midazolam 0.03 mg/kg dissolved in 5 ml normal saline (0.9%) using supraclavicular BPB

DRUG

Midazolam

0.03 mg/kg of midazolam by I.V. route

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2018-09-01
Completion
2018-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03185351 on ClinicalTrials.gov