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

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: Unknown
• Conditions: Arthroscopic Shoulder Surgery
• Intervention / Treatment: Drug: Bupivacaine; Drug: Propofol; Device: Ultrasound; Drug: Sevoflurane; Drug: Rocuronium; Drug: Bupivacaine-magnesium

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanaa M Elbendary, MD; Phone Number: 00201005781768; Email: hanaa_elbendary@yahoo.com
• Study Contact Backup: Name: Samah El Kenany, MD; Phone Number: 00201002262557; Email: sk_20022000@yahoo.com

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Mansoura university
      • Contact: Hanaa M Elbendary, MD; Phone Number: 00201005781768; Email: hanaa_elbendary@yahoo.com
      • Contact: Samah El Kenany, MD; Phone Number: 00201002262557; Email: sk_20022000@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score at rest	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	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		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
Intraoperative fentanyl requirements		For 5 hours after suprascapular nerve block
Sedation scores	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	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		For 24 hours after surgery
Number of antiemetics received		For 24 hours after surgery
Postoperative cumulative morphine consumption		For 24 hours after surgery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Hanaa M Elbendary, MD, Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Local; Anesthetics, Inhalation; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Propofol; Sevoflurane; Bupivacaine; Rocuronium
• Other Study ID 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