Arthroscopic Shoulder SurgeryNCT03602469
Postoperative Analgesia of Magnesium Sulfate in Suprascapular Nerve Block Following Shoulder Arthroscopy
A study testing Bupivacaine, Bupivacaine-magnesium and Propofol in people with Arthroscopic Shoulder Surgery, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthroscopic Shoulder Surgery
- What is being tested?
- Bupivacaine, Bupivacaine-magnesium and Propofol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2018to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III
Who cannot join
- Patient's refusal
- Significant cardiac diseases
- Significant hepatic diseases
- Significant renal diseases (serum creatinine ˃ 1.5 mg/dl)
- Cardiac conduction abnormalities
- Drug abuse
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University
Al Mansurah, DK, 050
Hanaa M Elbendary, MD, 00201005781768, hanaa_elbendary@yahoo.com
Samah El Kenany, MD, 00201002262557, sk_20022000@yahoo.com
About this study
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
- 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
Read the 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
- Being tested
- Bupivacaine, Bupivacaine-magnesium, Propofol, Ultrasound, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Ultrasound-guided suprascapular nerve block will be performed using 7 mL of 0.5% bupivacaine plus 3 mL of 0.9% saline
Bupivacaine-magnesiumDrug
Ultrasound-guided suprascapular nerve block will be performed using 7 mL of 0.5% bupivacaine plus magnesium sulfate 10% (3 ml) (total 10mL)
PropofolDrug
Using propofol 1.5-2.5 mg/kg
UltrasoundDevice
Ultrasound-guided suprascapular nerve block
SevofluraneDrug
Sevoflurane 0.7-1.5 MAC in 40% oxygen
RocuroniumDrug
Rocuronium 0.6 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | Ultrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia Receives: Drug: Bupivacaine; Drug: Propofol; Device: Ultrasound; Drug: Sevoflurane; Drug: Rocuronium |
| Bupivacaine-magnesium | Active comparator | Ultrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia Receives: Drug: Bupivacaine-magnesium; Drug: Propofol; Device: Ultrasound; Drug: Sevoflurane; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative analgesia
time from administering the study solution in the suprascapular block till the time for the first rescue morphine request
Measured: For 8 hours after suprascapular nerve block
Secondary outcomes (11)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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)
Measured: For 24 hours after surgery
Number of vomiting episodes
Measured: For 24 hours after surgery
Number of antiemetics received
Measured: For 24 hours after surgery
Postoperative cumulative morphine consumption
Measured: For 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startJul 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanaa M Elbendary, MD, Study chair, Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602469
- Sponsor's protocol ID
- R ∕18.04.172
- Status last verified
- Jun 2018
- First submitted
- 20 Jun 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03602469
- Acronym / sponsor ID
- R ∕18.04.172
- Conditions
- Arthroscopic Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: Bupivacaine, Drug: Propofol, Device: Ultrasound, Drug: Sevoflurane, Drug: RocuroniumUltrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia |
| Bupivacaine-magnesium | Active comparator | Drug: Bupivacaine-magnesium, Drug: Propofol, Device: Ultrasound, Drug: Sevoflurane, Drug: RocuroniumUltrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I-III
Key exclusion criteria (18 listed)
- Patient's refusal
- Significant cardiac diseases
- Significant hepatic diseases
- Significant renal diseases (serum creatinine ˃ 1.5 mg/dl)
- Cardiac conduction abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineUltrasound-guided suprascapular nerve block will be performed using 7 mL of 0.5% bupivacaine plus 3 mL of 0.9% saline | Drug | Bupivacaine |
| Bupivacaine-magnesiumUltrasound-guided suprascapular nerve block will be performed using 7 mL of 0.5% bupivacaine plus magnesium sulfate 10% (3 ml) (total 10mL) | Drug | Bupivacaine-magnesium |
| PropofolUsing propofol 1.5-2.5 mg/kg | Drug | Bupivacaine, Bupivacaine-magnesium |
| UltrasoundUltrasound-guided suprascapular nerve block | Device | Bupivacaine, Bupivacaine-magnesium |
| SevofluraneSevoflurane 0.7-1.5 MAC in 40% oxygen | Drug | Bupivacaine, Bupivacaine-magnesium |
| RocuroniumRocuronium 0.6 mg/kg | Drug | Bupivacaine, Bupivacaine-magnesium |
Primary outcome
Duration of postoperative analgesia
Time frame: For 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
11 secondary outcomes
Pain score at rest
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: For 5 hours after suprascapular nerve block
Sedation scores
Time frame: at 1 hour, 2 hours, and 6 hours postoperatively
The degree of nausea and vomiting
Time frame: For 24 hours after surgery
Number of vomiting episodes
Time frame: For 24 hours after surgery
Number of antiemetics received
Time frame: For 24 hours after surgery
Postoperative cumulative morphine consumption
Time frame: For 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanaa M Elbendary, MD study chair
Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine, Bupivacaine-magnesium and Propofol in people with Arthroscopic Shoulder Surgery, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanaa M Elbendary, MD (00201005781768, hanaa_elbendary@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of postoperative analgesia (time frame: For 8 hours after suprascapular nerve block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.