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

Arthroscopic Shoulder Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03602469
• Other study ID #: R /18.04.172
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2018
• Est. completion date: January 2019

Study information

• Verified date: June 2018
• Source: Mansoura University
• Contact: Hanaa M Elbendary, MD
• Phone: 00201005781768
• Email: hanaa_elbendary[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroscopic Shoulder Surgery

Intervention

Drug:
• Bupivacaine
Ultrasound-guided suprascapular nerve block will be performed using 7 mL of 0.5% bupivacaine plus 3 mL of 0.9% saline
• 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)
• 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
• Rocuronium
Rocuronium 0.6 mg/kg

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Intraoperative fentanyl requirements		For 5 hours after suprascapular nerve block
Secondary	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
Secondary	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
Secondary	Number of vomiting episodes		For 24 hours after surgery
Secondary	Number of antiemetics received		For 24 hours after surgery
Secondary	Postoperative cumulative morphine consumption		For 24 hours after surgery