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

Not Applicable
Conditions
Arthroscopic Shoulder Surgery
Interventions
Drug: Bupivacaine-magnesium
Device: Ultrasound
Registration Number
NCT03602469
Lead Sponsor
Mansoura University
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Bupivacaine-magnesiumBupivacaine-magnesiumUltrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia
BupivacaineUltrasoundUltrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia
Bupivacaine-magnesiumUltrasoundUltrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia
BupivacaineRocuroniumUltrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia
BupivacaineBupivacaineUltrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia
BupivacainePropofolUltrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia
BupivacaineSevofluraneUltrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia
Bupivacaine-magnesiumPropofolUltrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia
Bupivacaine-magnesiumSevofluraneUltrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia
Bupivacaine-magnesiumRocuroniumUltrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia
Primary Outcome Measures
NameTimeMethod
Duration of postoperative analgesiaFor 8 hours after suprascapular nerve block

time from administering the study solution in the suprascapular block till the time for the first rescue morphine request

Secondary Outcome Measures
NameTimeMethod
Postoperative cumulative morphine consumptionFor 24 hours after surgery
Number of antiemetics receivedFor 24 hours after surgery
Intraoperative fentanyl requirementsFor 5 hours after suprascapular nerve block
Systolic arterial blood pressureAt 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
Number of vomiting episodesFor 24 hours after surgery
Pain score at resttime 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 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)

Pain score on shoulder abductiontime 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 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)

Diastolic arterial blood pressureAt 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 rateAt 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
The degree of nausea and vomitingFor 24 hours after surgery

Nausea will be measured using a numerical rating system (none= 0; mild= 1; moderate= 2; severe= 3)

Sedation scoresat 1 hour, 2 hours, and 6 hours postoperatively

Sedation: will be assessed using a sedation scale (awake and alert= 0; quietly awake= 1; asleep but easily roused= 2; deep asleep= 3).

Trial Locations

Locations (1)

Mansoura University

🇪🇬

Mansourah, DK, Egypt

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