Postoperative Analgesia of Magnesium Sulfate in Suprascapular Nerve Block Following Shoulder Arthroscopy

July 18, 2018 updated by: Mansoura University

Efficacy of Magnesium Sulfate Added to Bupivacaine in Suprascapular Nerve Block on Duration of Analgesia Following Shoulder Arthroscopy: a Prospective Randomized Controlled Study

  • Arthroscopic shoulder surgeries in adults are accompanied with severe immediate postoperative pain reported in approximately 45% of patients. For quicker recovery and rehabilitation of these patients, postoperative analgesia is mandatory.
  • Different analgesic modalities have been proposed including parenteral opioids, intra-articular injection of local anesthetics, interscalene brachial plexus block (ISB), and a suprascapular nerve block (SSNB), with varying degrees of effectiveness and multiple reported side effects.
  • A recent meta-analysis demonstrates that suprascapular block results in 24-h morphine consumption and pain scores similar to ISB, so, it may be considered an effective and safe alternative for interscalene block in shoulder surgery, with less motor restriction, and fewer complications.
  • Different agents are used as adjuvants to local anesthetics during peripheral nerve block to prolong its analgesic action including magnesium sulfate.
  • A meta-analysis by Mengzhu et al., concluded that magnesium sulfate combined with local anesthetics in perineural nerve blocks provided better analgesic efficacy and may be a promising analgesic for perineural nerve blocks.
  • Antinociceptive effects of magnesium are due to the regulation of calcium influx into the cell and a non-competitive antagonism of the NMDA receptors

Study Overview

Status

Status

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

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 aim of this study is to evaluate the effects of magnesium sulfate as an adjuvant to bupivacaine in suprascapular nerve block on the duration and quality of postoperative analgesia following shoulder arthroscopy, postoperative pain VAS scores, intraoperative fentanyl requirements, sedation scores, respiratory depression, postoperative 24 hours cumulative morphine consumption.

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 (Anticipated)

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.
60

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • DK
      • Mansourah, DK, Egypt, 050
        • Mansoura University

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical status I-III

Exclusion Criteria:

  • Patient's refusal
  • Significant cardiac diseases
  • Significant hepatic diseases
  • Significant renal diseases (serum creatinine ˃ 1.5 mg/dl)
  • Cardiac conduction abnormalities
  • Drug abuse
  • Pregnancy
  • Allergy to study medications
  • Mental disease
  • Communication barrier
  • Coagulopathy
  • Local skin infection
  • Traumatic nerve injury of upper limb
  • Patients receiving opioid analgesics
  • Patients receiving magnesium sulfate
  • Patients receiving beta blockers
  • Patients receiving calcium channel blockers
  • Previous shoulder surgery

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: Double

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: Bupivacaine
Ultrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia
Drug: Bupivacaine
Ultrasound-guided suprascapular nerve block will be performed using 7 mL of 0.5% bupivacaine plus 3 mL of 0.9% saline
Drug: Propofol
Using propofol 1.5-2.5 mg/kg
Device: Ultrasound
Ultrasound-guided suprascapular nerve block
Drug: Sevoflurane
Sevoflurane 0.7-1.5 MAC in 40% oxygen
Drug: Rocuronium
Rocuronium 0.6 mg/kg
Active Comparator: Bupivacaine-magnesium
Ultrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia
Drug: Propofol
Using propofol 1.5-2.5 mg/kg
Device: Ultrasound
Ultrasound-guided suprascapular nerve block
Drug: Sevoflurane
Sevoflurane 0.7-1.5 MAC in 40% oxygen
Drug: Rocuronium
Rocuronium 0.6 mg/kg
Drug: Bupivacaine-magnesium
Ultrasound-guided suprascapular nerve block will be performed using 7 mL of 0.5% bupivacaine plus magnesium sulfate 10% (3 ml) (total 10mL)

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
Duration of postoperative analgesia
Time Frame: For 8 hours after suprascapular nerve block
time from administering the study solution in the suprascapular block till the time for the first rescue morphine request
For 8 hours after suprascapular nerve block

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
Pain score at rest
Time Frame: time 0 (after extubating) and at 30 minutes, 1 hour , 2 hours, 4hours, 6hours, 8hours,12 hours , 16hours, 20 hours and 24 hours postoperatively
Pain score as assessed using visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and 100 mm for worst imaginable pain)
time 0 (after extubating) and at 30 minutes, 1 hour , 2 hours, 4hours, 6hours, 8hours,12 hours , 16hours, 20 hours and 24 hours postoperatively
Pain score on shoulder abduction
Time Frame: time 0 (after extubating) and at 30 minutes, 1 hour , 2 hours, 4hours, 6hours, 8hours,12 hours , 16hours, 20 hours and 24 hours postoperatively
Pain score as assessed using visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and 100 mm for worst imaginable pain)
time 0 (after extubating) and at 30 minutes, 1 hour , 2 hours, 4hours, 6hours, 8hours,12 hours , 16hours, 20 hours and 24 hours postoperatively
Systolic arterial blood pressure
Time Frame: At baseline, immediately after induction of anaesthesia, at skin incision, every 15 minutes till the end of surgery, on arrival to PACU, then at 30, 60 minutes after surgery , every 6 hours up to 24 hours postoperatively
At baseline, immediately after induction of anaesthesia, at skin incision, every 15 minutes till the end of surgery, on arrival to PACU, then at 30, 60 minutes after surgery , every 6 hours up to 24 hours postoperatively
Diastolic arterial blood pressure
Time Frame: At baseline, immediately after induction of anaesthesia, at skin incision, every 15 minutes till the end of surgery, on arrival to PACU, then at 30, 60 minutes after surgery , every 6 hours up to 24 hours postoperatively
At baseline, immediately after induction of anaesthesia, at skin incision, every 15 minutes till the end of surgery, on arrival to PACU, then at 30, 60 minutes after surgery , every 6 hours up to 24 hours postoperatively
Heart rate
Time Frame: At baseline, immediately after induction of anaesthesia, at skin incision, every 15 minutes till the end of surgery, on arrival to PACU, then at 30, 60 minutes after surgery ,every 6 hours up to 24 hours postoperatively
At baseline, immediately after induction of anaesthesia, at skin incision, every 15 minutes till the end of surgery, on arrival to PACU, then at 30, 60 minutes after surgery ,every 6 hours up to 24 hours postoperatively
Intraoperative fentanyl requirements
Time Frame: For 5 hours after suprascapular nerve block
For 5 hours after suprascapular nerve block
Sedation scores
Time Frame: at 1 hour, 2 hours, and 6 hours postoperatively
Sedation: will be assessed using a sedation scale (awake and alert= 0; quietly awake= 1; asleep but easily roused= 2; deep asleep= 3).
at 1 hour, 2 hours, and 6 hours postoperatively
The degree of nausea and vomiting
Time Frame: For 24 hours after surgery
Nausea will be measured using a numerical rating system (none= 0; mild= 1; moderate= 2; severe= 3)
For 24 hours after surgery
Number of vomiting episodes
Time Frame: For 24 hours after surgery
For 24 hours after surgery
Number of antiemetics received
Time Frame: For 24 hours after surgery
For 24 hours after surgery
Postoperative cumulative morphine consumption
Time Frame: For 24 hours after surgery
For 24 hours after surgery

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.
Mansoura 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 Chair: Hanaa M Elbendary, MD, Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

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 (Anticipated)

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.
July 1, 2018

Primary Completion (Anticipated)

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.
December 1, 2018

Study Completion (Anticipated)

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.
January 1, 2019

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).
June 20, 2018

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.
July 18, 2018

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.
July 26, 2018

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.
July 26, 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.
July 18, 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.
June 1, 2018

More Information

Terms related to this study

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.
  • R ∕18.04.172

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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