Efficacy of Different Medications as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries

April 22, 2025 updated by: Mohammed Gaber Saad, Al-Azhar University

Efficacy of Dexmedetomidine, Dexamethasone, and Magnesium Sulphate as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries - A Randomized Clinical Trial

This study is to evaluate whether addition of dexmedetomidine, dexamethasone and magnesium sulfate as adjuvants to bupivacaine in supraclavicular Brachial Plexus Blockade (BPB) for pain management assessed by VAS score.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

This is a randomized controlled study involving 105 participants divided into three groups to assess the efficacy of adding dexmedetomidine, dexamethasone, and magnesium sulfate as adjuvants to bupivacaine in supraclavicular brachial plexus blockade during upper limb surgeries. The primary outcome is the postoperative Visual Analog Scale (VAS) score. The secondary outcomes are assessment of onset and duration of the block, patient satisfaction, and adverse effects.

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 (Estimated)

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.
105

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.
  • Not Applicable

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
      • Cairo, Egypt, 11884
        • Faculity of medicine - Al-Azhar University hospitals

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) status of I and II
  • undergoing forearm surgeries

Exclusion Criteria:

  • coagulopathies
  • Local skin lesions
  • Pregnancy
  • Has a history of significant neurological, psychiatric, or neuromuscular disorders
  • Patients refusing participation
  • BMI > 40
  • Patient with COPD. hypersensitivity or allergies to local anesthesia

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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.
Experimental: Group A (DT): Dexmedetomidine group
A group of 35 participants will receive 18 ml of bupivacaine 0.5% plus dexmedetomidine 100 µg for the supraclavicular block.
Procedure: Group A (DT): Dexmedetomidine group
The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 100 µg Dexmeditomidine and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.
Experimental: Group B (MG): Magnesium group
A group of 35 participants will receive 18 ml of bupivacaine 0.5% plus magnesium sulfate 150 mg in 2 ml of normal saline for the same block.
Procedure: Group B (MG): Magnesium group
The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 150 mg of magnesium sulfate and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.
Active Comparator: Group C (DM): Dexamethasone group
A group of 35 participants will receive 18 ml of bupivacaine 0.5% plus dexamethasone 8 mg for the same block.
Procedure: Group C (DM): Dexamethasone group
The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 8 mg dexamethasone and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.

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
-Post operative Visual analogue scale VAS score
Time Frame: Over 24 hours post operative starting from transeferring the patient to the recovery area.
Assess post-operative VAS score at: T0 (after transferring to the recovery area), at T1: at two hours, T3: at four hours, T4: at six hours, T5: at eight hours, T6: at 10 hours, T7: at 12 hours, T8: at 16 hours, T9: at 20 hours, and T10 at 24 hours postoperatively.
Over 24 hours post operative starting from transeferring the patient to the recovery area.

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
Onst of sensory block
Time Frame: Complete sensory block will be assessed every 5 min up to a maximum of 30 minutes
Time in minutes from completing the block to complete sensory loss to sensation of a cold cotton pad relative to the contralateral limb.
Complete sensory block will be assessed every 5 min up to a maximum of 30 minutes
Onset of motor block
Time Frame: Complete motor block will be assessed every 5 min up to a maximum of 30 minutes
Time in minutes from completing the block up to the time when the patient is unable to overcome gravity relative to the contralateral arm.
Complete motor block will be assessed every 5 min up to a maximum of 30 minutes
Duration of the sensory block
Time Frame: Sensation will be assessed every 4 hours till return of normal sensation up to maximum 24 hours .
Complete return of the sensation in the blocked limb relative to the contralateral arm.
Sensation will be assessed every 4 hours till return of normal sensation up to maximum 24 hours .
duration of the motor block
Time Frame: Motor power will be assessed every 4 hours till return of normal sensation up to maximum 24 hourswill be assessed every 4 hours till return of normal sensation up to maximum 24 hours
Complete return of the motor power in the blocked limb
Motor power will be assessed every 4 hours till return of normal sensation up to maximum 24 hourswill be assessed every 4 hours till return of normal sensation up to maximum 24 hours
Intraoperative mean arterial blood pressure
Time Frame: From positioning the patient to the block upto 90 minutes from removing the needle
Mean arterial blood pressure in mmHg will be assessed at T0: baseline before patient positing for the block, at T1: just after removing the needle, at T2: at 30 minutes, T3: at 60 Minutes , and T4: at 90 minutes intraoperatively
From positioning the patient to the block upto 90 minutes from removing the needle
Intraoperative Pulse rate.
Time Frame: From positioning the patient to the block upto 90 minutes from removing the needle
pulse rate per minute will be assessed at T0: baseline before patient positing for the block, at T1: just after removing the needle, at T2: at 30 minutes, T3: at 60 Minutes, and T4: at 90 minutes intraoperatively
From positioning the patient to the block upto 90 minutes from removing the needle
Post operative opioid consumption
Time Frame: Over 24 hours post operatively started form transferring the patient to the recovery area
Postoperative total doses of pethidine in milligrams will be counted. For patients with a VAS score of more than 4, pethidine 50mg will be given intramuscularly.
Over 24 hours post operatively started form transferring the patient to the recovery area
Post operative Nausea and vomiting
Time Frame: Over 24 hours post operative starting from transferring to the recovery area.
Nausea and vomiting attacks will be recorded over 24 hours postoperatively.
Over 24 hours post operative starting from transferring to the recovery area.
Postoperative transient neurologic symptoms
Time Frame: Over 48 hours post operative starting from transeferring to the recovery area.
Dysesthesia will be assessed every 12 hours postoperatively and reported
Over 48 hours post operative starting from transeferring to the recovery area.

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.
Al-Azhar University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hend Mostafa Abosaifa, MD, Al-Azhar University
  • Principal Investigator: Fatma Alzahraa Roshdy Elkemary, MD, Al-Azhar Unversity
  • Study Chair: Noha Mohamed Elsai, MD, Al-Azhar Unversity
  • Principal Investigator: Ain ELmarwa Abdelmonem Abdallah, MD, Al-Azhar Unversity
  • Study Chair: Nashwa Mohammed Ibrahiem, MD, Al-Azhar Unversity
  • Study Chair: Wafaa Abd Ali Elhadi, MD, Al-Azhar Unversity
  • Principal Investigator: Hanaa Said Rashed, MD, National liver institute Menofia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
December 1, 2024

Primary Completion (Estimated)

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.
June 30, 2025

Study Completion (Estimated)

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.
July 30, 2025

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).
April 22, 2025

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.
April 22, 2025

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.
April 29, 2025

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.
April 29, 2025

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.
April 22, 2025

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.
April 1, 2025

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.
  • RHDIRB2018122002

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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