Midazolam in Supraclavicular Brachial Plexus Block

September 21, 2018 updated by: RAGAA AHMED HERDAN, Assiut University

Perineural Versus Intravenous Midazolam in Patients Undergoing Forearm Orthopedic Surgeries Using Supraclavicular Brachial Plexus Block

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The day prior to surgery, all patients will undergo pre-anesthetic checkup including detailed history, thorough general, physical, systemic examination and weight of the patient. All patients will be kept nil by mouth for at least 6 hours.

  • Written consent, coagulation profile, intravenous line, emergency resuscitation equipments including airway devices, advanced cardiac life support drugs for LA toxicity will be available.
  • Patients will be monitored using standard monitoring (ECG, non-invasive blood pressure and pulsoximetry)
  • All patients will be lightly sedated with 1 mg midazolam I.V. SonoAce 6 ultrasound machine with high frequency linear probe will be used in our study.

Palpation of the subclavian artery in the supraclvicular fossa, just lateral to the sternocledomastoid and above the clavicle (landmark located one finger or 1 cm above the clavicle at the junction of inner 2/3 and outer 1/3 of clavicle).

Position to perform supraclavicular BPB; the anesthetist will stand behind the patient's head, with the ultrasound machine on the side being blocked. The head of the bed is slightly raised to allow the shoulder to drop somewhat the patient's head will be turned to the opposite side, resting directly on the table without a pillow, the hand holding the probe will rest against the patient's jaw, the probe is placed in the supraclavicular fossa in a coronal oblique plane, the needle will be inserted from the lateral side, The pulsating hypoechoic supraclavicular artery is identified, lying above the hyperechoic first rib, the probe is then angled until both the first rib and the pleura are also seen simultaneously, The nerve structures (trunks or divisions) are usually visualized as a collection of hypoechoic round structures (a bunch of grapes) lying superior and postero-lateral to the subclavian artery. A 3 cm long 22 G needle with 10 cc syringe filled with respective LA agent will be inserted directing downward, forward and medially at the angle of 20° to the skin till the parasthesia elicited in the hand or the 1st rib hit, then the needle will be fixed at that point. After the negative aspiration respective agents will be given. A gentle massage over the area will be done with an idea of uniform spread. All brachial plexus injections will be administered slowly with repeated aspiration to prevent or detect early intravascular injection. The end of the injection will be considered time 0.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: BUPIVACAINE

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

.
Drug: Bupivacaine
20 ml of 0.5% bupivacaine using supraclavicular BPB.
Active Comparator: BUPIVACAINE and midazolam
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
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
Active Comparator: BUPIVACAINE and i.v midazolam
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numerical rating pain scale graded from 0 to 10
Time Frame: 24 hours
postoperative analgesic efficacy of ultrasound guided supraclavicular BPB
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Motor blockade
Time Frame: 24 hours
Modified Bromage Score
24 hours
Sedation Score
Time Frame: 24 hours
(Awake and alert -1, Sedated and responding to verbal command-2, Sedated and responding to mild stimulus-3, Sedated and responding to moderate to severe physical stimulus-4).
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Brachial Plexus Block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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