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

NCT ID: NCT03602469

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2019-01-31

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

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.

Conditions

Arthroscopic Shoulder Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Bupivacaine

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

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

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

Propofol

Intervention Type: DRUG

Using propofol 1.5-2.5 mg/kg

Ultrasound

Intervention Type: DEVICE

Ultrasound-guided suprascapular nerve block

Sevoflurane

Intervention Type: DRUG

Sevoflurane 0.7-1.5 MAC in 40% oxygen

Rocuronium

Intervention Type: DRUG

Rocuronium 0.6 mg/kg

Bupivacaine-magnesium

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine-magnesium

Intervention Type: DRUG

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

Propofol

Intervention Type: DRUG

Using propofol 1.5-2.5 mg/kg

Ultrasound

Intervention Type: DEVICE

Ultrasound-guided suprascapular nerve block

Sevoflurane

Intervention Type: DRUG

Sevoflurane 0.7-1.5 MAC in 40% oxygen

Rocuronium

Intervention Type: DRUG

Rocuronium 0.6 mg/kg

Interventions

Bupivacaine

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

Intervention Type: 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)

Intervention Type: DRUG

Propofol

Using propofol 1.5-2.5 mg/kg

Intervention Type: DRUG

Ultrasound

Ultrasound-guided suprascapular nerve block

Intervention Type: DEVICE

Sevoflurane

Sevoflurane 0.7-1.5 MAC in 40% oxygen

Intervention Type: DRUG

Rocuronium

Rocuronium 0.6 mg/kg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanaa M Elbendary, MD

Role: STUDY_CHAIR

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

Locations

Mansoura University

Al Mansurah, DK, Egypt

Countries

Egypt

Central Contacts

Hanaa M Elbendary, MD

Role: CONTACT

hanaa_elbendary@yahoo.com

00201005781768

Samah El Kenany, MD

Role: CONTACT

sk_20022000@yahoo.com

00201002262557

Facility Contacts

Hanaa M Elbendary, MD

Role: primary

hanaa_elbendary@yahoo.com

00201005781768

Samah El Kenany, MD

Role: backup

sk_20022000@yahoo.com

00201002262557

Other Identifiers

R ∕18.04.172

Identifier Type: -

Identifier Source: org_study_id