Midazolam in Supraclavicular Brachial Plexus Block

NCT03185351 | Completed Phase 2

• 1 other identifier: brachial plexus block
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

midazolam; brachial plexus block

Outcome Measures

Primary Outcomes (1)

• Numerical rating pain scale graded from 0 to 10

  postoperative analgesic efficacy of ultrasound guided supraclavicular BPB

  24 hours

Secondary Outcomes (2)

• Motor blockade

  24 hours

• Sedation Score

  24 hours

Study Arms (3)

BUPIVACAINE

ACTIVE COMPARATOR

patients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB. .

Drug: Bupivacaine

BUPIVACAINE and midazolam

ACTIVE COMPARATOR

patients will receive 20 ml of 0.5% bupivacaine + midazolam 0.03 mg/kg dissolved in 5 ml normal saline (0.9%) using supraclavicular BPB.

Drug: Bupivacaine; Drug: Midazolam

BUPIVACAINE and i.v midazolam

ACTIVE COMPARATOR

patients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB + 0.03 mg/kg of midazolam by I.V. route at the same time of the block

Drug: Bupivacaine; Drug: Midazolam

Interventions

Bupivacaine DRUG

20 ml of 0.5% bupivacaine using supraclavicular BPB.

BUPIVACAINE; BUPIVACAINE and i.v midazolam; BUPIVACAINE and midazolam

Midazolam DRUG

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

BUPIVACAINE and midazolam

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I-II physical status patients.
• Age between 18 and 50 years.
• Patients planned for unilateral orthopedic forearm surgeries.

You may not qualify if:

• Patient refusal
• Any contraindication to regional block (i.e. coagulopathy, infection at the needle insertion site, contralateral pneumothorax or diaphragmatic paralysis)
• Bilateral limb surgery
• Pregnancy
• BMI \>35
• Preexisting neuropathy involving the surgical limb
• Patients with any known contraindication to study medications
• History of a major psychiatric disorder.
• Chronic pain syndrome.
• History of substance abuse.
• Current opioid use.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Midazolam

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care

Model Details: * Group A: patients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB. * Group B: patients will receive 20 ml of 0.5% bupivacaine + midazolam 0.03 mg/kg dissolved in 5 ml normal saline (0.9%) using supraclavicular BPB. * Group C: patients will receive 20 ml of 0.5% bupivacaine + 5 ml normal saline (0.9%) using supraclavicular BPB + 0.03 mg/kg of midazolam by I.V. route at the same time of the block.

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: June 14, 2017
• Study Start: June 14, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

EG (1)