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

NCT03602469 | Unknown DMC

• 1 other identifier: R ∕18.04.172
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Arthroscopic Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative analgesia

  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 Outcomes (11)

• Pain score at rest

  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 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

  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

  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

  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

Study Arms (2)

Bupivacaine

EXPERIMENTAL

Ultrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia

Drug: Bupivacaine; Drug: Propofol; Device: Ultrasound; Drug: Sevoflurane; Drug: Rocuronium

Bupivacaine-magnesium

ACTIVE COMPARATOR

Ultrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia

Drug: Bupivacaine-magnesium; Drug: Propofol; Device: Ultrasound; Drug: Sevoflurane; Drug: Rocuronium

Interventions

Bupivacaine DRUG

Ultrasound-guided suprascapular nerve block will be performed using 7 mL of 0.5% bupivacaine plus 3 mL of 0.9% saline

Bupivacaine

Bupivacaine-magnesium DRUG

Ultrasound-guided suprascapular nerve block will be performed using 7 mL of 0.5% bupivacaine plus magnesium sulfate 10% (3 ml) (total 10mL)

Bupivacaine-magnesium

Propofol DRUG

Using propofol 1.5-2.5 mg/kg

Bupivacaine; Bupivacaine-magnesium

Ultrasound DEVICE

Ultrasound-guided suprascapular nerve block

Bupivacaine; Bupivacaine-magnesium

Sevoflurane DRUG

Sevoflurane 0.7-1.5 MAC in 40% oxygen

Bupivacaine; Bupivacaine-magnesium

Rocuronium DRUG

Rocuronium 0.6 mg/kg

Bupivacaine; Bupivacaine-magnesium

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Propofol; Ultrasonography; Sevoflurane; Rocuronium

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hanaa M Elbendary, MD

  Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

  STUDY CHAIR

Central Study Contacts

Hanaa M Elbendary, MD

CONTACT

00201005781768; hanaa_elbendary@yahoo.com

Samah El Kenany, MD

CONTACT

00201002262557; sk_20022000@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 26, 2018
• Study Start: July 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 26, 2018

Record last verified: 2018-06

Locations

EG (1)