Clinical trial NCT03602469: Postoperative Analgesia of Magnesium Sulfate in Suprascapular Nerve Block Following Shoulder Arthroscopy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroscopic Shoulder Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Duration of postoperative analgesia
timeFrame: For 8 hours after suprascapular nerve block
Secondary outcomes:
measure: Pain score at rest
timeFrame: time 0 (after extubating) and at 30 minutes, 1 hour , 2 hours, 4hours, 6hours, 8hours,12 hours , 16hours, 20 hours and 24 hours postoperatively
measure: Pain score on shoulder abduction
timeFrame: time 0 (after extubating) and at 30 minutes, 1 hour , 2 hours, 4hours, 6hours, 8hours,12 hours , 16hours, 20 hours and 24 hours postoperatively
measure: Systolic arterial blood pressure
timeFrame: 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
measure: Diastolic arterial blood pressure
timeFrame: 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
measure: Heart rate
timeFrame: 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
measure: Intraoperative fentanyl requirements
timeFrame: For 5 hours after suprascapular nerve block
measure: Sedation scores
timeFrame: at 1 hour, 2 hours, and 6 hours postoperatively
measure: The degree of nausea and vomiting
timeFrame: For 24 hours after surgery
measure: Number of vomiting episodes
timeFrame: For 24 hours after surgery
measure: Number of antiemetics received
timeFrame: For 24 hours after surgery
measure: Postoperative cumulative morphine consumption
timeFrame: For 24 hours after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
name: Hanaa M Elbendary, MD
role: STUDY_CHAIR
References: