Postoperative PainNCT07918521
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
A study testing Combined Costoclavicular and Suprascapular Nerve Block with Magnesium Sulfate and Interscalene Brachial Plexus Block with Magnesium Sulfate in people with Postoperative Pain and Shoulder Arthroscopy, run by Assiut University.
Trial summary
Shoulder arthroscopy is a common outpatient procedure that can cause moderate to severe pain during the first 24 to 48 hours after surgery. An interscalene brachial plexus block (ISB) is widely used to provide pain relief, but it frequently causes temporary weakness or paralysis of the diaphragm (the main breathing… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Shoulder Arthroscopy, Hemidiaphragmatic Paresis
- What is being tested?
- Combined Costoclavicular and Suprascapular Nerve Block with Magnesium Sulfate and Interscalene Brachial Plexus Block with Magnesium Sulfate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18-65 years.
- American Society of Anesthesiologists (ASA) physical status class I or II.
- Scheduled for elective outpatient shoulder arthroscopy under general anesthesia.
- Ability to understand the study procedures and provide written informed consent.
- Ability to understand and utilize the Numeric Rating Scale (NRS) for postoperative pain assessment.
Who cannot join
- Refusal to participate or withdrawal of informed consent.
- Known allergy or hypersensitivity to bupivacaine, magnesium sulfate, or any components of the study medications.
- Coagulopathy or ongoing anticoagulant therapy contraindicating regional anesthesia.
- Local infection or anatomic contraindication at the planned block puncture sites.
- Pre-existing peripheral neuropathy, neuromuscular disease, or neurological deficit involving the operative upper limb.
- Severe pulmonary disease or respiratory insufficiency.
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- Body mass index (BMI) > 40 kg/m².
- Chronic opioid use or pre-existing chronic pain syndromes that may interfere with postoperative pain evaluation.
- Pregnancy or lactation.
- Inability to communicate adequately or complete postoperative pain and follow-up assessments.
About this study
Official title: Magnesium Sulphate as an Adjuvant in Both Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Ambulatory Shoulder Arthroscopy
Shoulder arthroscopy is a common outpatient procedure that can cause moderate to severe pain during the first 24 to 48 hours after surgery. An interscalene brachial plexus block (ISB) is widely used to provide pain relief, but it frequently causes temporary weakness or paralysis of the diaphragm (the main breathing muscle) by blocking the phrenic nerve, which can lead to shortness of breath. A combined costoclavicular and suprascapular nerve block (CCB-SSNB) has emerged as an alternative approach that numbs the shoulder while potentially preserving normal breathing and diaphragmatic function. Additionally, adding magnesium sulfate as an adjuvant medication to local anesthetics can help prolong and enhance pain relief.
The primary purpose of this study is to compare the pain-relieving efficacy and respiratory safety of ultrasound-guided combined CCB-SSNB versus standard ISB, both administered with magnesium sulfate as an adjuvant, in adult patients undergoing elective outpatient shoulder arthroscopy under general anesthesia.
Read more
Participants will be randomly assigned to one of two groups prior to surgery:
- Group A (Combined CCB-SSNB): Participants will receive an ultrasound-guided suprascapular nerve block (10 mL of 0.5% bupivacaine with 100 mg magnesium sulfate) and an ultrasound-guided costoclavicular block (10 mL of 0.5% bupivacaine with 100 mg magnesium sulfate).
- Group B (ISB): Participants will receive an ultrasound-guided interscalene block (20 mL of 0.5% bupivacaine with 200 mg magnesium sulfate).
The primary outcome is the duration of pain relief, measured as the time from the end of surgery until the patient first requests rescue pain medication. Secondary outcomes include total opioid consumption during the first 24 hours postoperatively, pain scores at rest and during movement up to 48 hours, ultrasound evaluation of diaphragmatic movement to detect hemidiaphragmatic paresis, recovery time in the post-anesthesia care unit (PACU), patient satisfaction, and any block-related side effects or complications.
- Being tested
- Combined Costoclavicular and Suprascapular Nerve Block with Magnesium Sulfate, Interscalene Brachial Plexus Block with Magnesium Sulfate
- Keywords
- Costoclavicular block, Suprascapular nerve block, Interscalene brachial plexus block, Magnesium sulfate, Diaphragmatic excursion, Ambulatory surgery, Opioid-sparing analgesia, Ultrasound-guided regional anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Costoclavicular and Suprascapular Nerve Block with Magnesium SulfateProcedure or surgery
Under ultrasound guidance and sterile technique, patients receive a single-shot suprascapular nerve block (SSNB) with 10 mL of 0.5% bupivacaine and 100 mg magnesium sulfate, followed by a costoclavicular brachial plexus block (CCB) with 10 mL of 0.5% bupivacaine and 100 mg magnesium sulfate (total volume: 20 mL bupivacaine 0.5% + 200 mg magnesium sulfate) administered prior to general anesthesia induction.
Interscalene Brachial Plexus Block with Magnesium SulfateProcedure or surgery
Under ultrasound guidance and sterile technique, patients receive a single-shot interscalene brachial plexus block (ISB) with 20 mL of 0.5% bupivacaine and 200 mg magnesium sulfate administered prior to general anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Combined CCB-SSNB with Magnesium Sulfate | Experimental | Patients receive a single-shot ultrasound-guided suprascapular nerve block (SSNB) with 10 mL of 0.5% bupivacaine and 100 mg magnesium sulfate, followed by an ultrasound-guided costoclavicular brachial plexus block (CCB) with 10 mL of 0.5% bupivacaine and 100 mg magnesium sulfate prior to induction of general anesthesia. Receives: Procedure: Combined Costoclavicular and Suprascapular Nerve Block with Magnesium Sulfate |
| Group B: Interscalene Block with Magnesium Sulfate | Active comparator | Patients receive a single-shot ultrasound-guided interscalene brachial plexus block (ISB) with 20 mL of 0.5% bupivacaine and 200 mg magnesium sulfate prior to induction of general anesthesia. Receives: Procedure: Interscalene Brachial Plexus Block with Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Postoperative Rescue Analgesic Request
Measured as the time (in hours) from the end of surgery (tracheal extubation) until the first administration of rescue analgesia, triggered when the patient requests pain relief or when the Numeric Rating Scale (NRS) pain score is >= 4 out of 10. Rescue analgesia consists of intravenous morphine.
Measured: Up to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wasseem Farah Ezzat Fawzy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918521
- Sponsor's protocol ID
- MgSO4 in CCB+SSNB vs ISB
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulphate as an Adjuvant in Both Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Ambulatory Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT07918521
- Acronym / sponsor ID
- MgSO4 in CCB+SSNB vs ISB
- Keywords
- Costoclavicular block, Suprascapular nerve block, Interscalene brachial plexus block, Magnesium sulfate, Diaphragmatic excursion, Ambulatory surgery, Opioid-sparing analgesia, Ultrasound-guided regional anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Nov 2026 (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.
Shoulder arthroscopy is a common outpatient procedure that can cause moderate to severe pain during the first 24 to 48 hours after surgery. An interscalene brachial plexus block (ISB) is widely used to provide pain relief, but it frequently causes temporary weakness or paralysis of the diaphragm (the main breathing muscle) by blocking the phrenic nerve, which can lead to shortness of breath. A combined costoclavicular and suprascapular nerve block (CCB-SSNB) has emerged as an alternative approach that numbs the shoulder while potentially preserving normal breathing and diaphragmatic function. Additionally, adding magnesium sulfate as an adjuvant medication to local anesthetics can help prolong and enhance pain relief.
The primary purpose of this study is to compare the pain-relieving efficacy and respiratory safety of ultrasound-guided combined CCB-SSNB versus standard ISB, both administered with magnesium sulfate as an adjuvant, in adult patients undergoing elective outpatient shoulder arthroscopy under general anesthesia.
Participants will be randomly assigned to one of two groups prior to surgery:
- Group A (Combined CCB-SSNB): Participants will receive an ultrasound-guided suprascapular nerve block (10 mL of 0.5% bupivacaine with 100 mg magnesium sulfate) and an ultrasound-guided costoclavicular block (10 mL of 0.5% bupivacaine with 100 mg magnesium sulfate).
- Group B (ISB): Participants will receive an ultrasound-guided interscalene block (20 mL of 0.5% bupivacaine with 200 mg magnesium sulfate).
The primary outcome is the duration of pain relief, measured as the time from the end of surgery until the patient first requests rescue pain medication. Secondary outcomes include total opioid consumption during the first 24 hours postoperatively, pain scores at rest and during movement up to 48 hours, ultrasound evaluation of diaphragmatic movement to detect hemidiaphragmatic paresis, recovery time in the post-anesthesia care unit (PACU), patient satisfaction, and any block-related side effects or complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Combined CCB-SSNB with Magnesium Sulfate | Experimental | Procedure: Combined Costoclavicular and Suprascapular Nerve Block with Magnesium SulfatePatients receive a single-shot ultrasound-guided suprascapular nerve block (SSNB) with 10 mL of 0.5% bupivacaine and 100 mg magnesium sulfate, followed by an ultrasound-guided costoclavicular brachial plexus block (CCB) with 10 mL of 0.5% bupivacaine and 100 mg magnesium sulfate prior to induction of general anesthesia. |
| Group B: Interscalene Block with Magnesium Sulfate | Active comparator | Procedure: Interscalene Brachial Plexus Block with Magnesium SulfatePatients receive a single-shot ultrasound-guided interscalene brachial plexus block (ISB) with 20 mL of 0.5% bupivacaine and 200 mg magnesium sulfate prior to 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 (5 listed)
- Age 18-65 years.
- American Society of Anesthesiologists (ASA) physical status class I or II.
- Scheduled for elective outpatient shoulder arthroscopy under general anesthesia.
- Ability to understand the study procedures and provide written informed consent.
- Ability to understand and utilize the Numeric Rating Scale (NRS) for postoperative pain assessment.
Key exclusion criteria (10 listed)
- Refusal to participate or withdrawal of informed consent.
- Known allergy or hypersensitivity to bupivacaine, magnesium sulfate, or any components of the study medications.
- Coagulopathy or ongoing anticoagulant therapy contraindicating regional anesthesia.
- Local infection or anatomic contraindication at the planned block puncture sites.
- Pre-existing peripheral neuropathy, neuromuscular disease, or neurological deficit involving the operative upper limb.
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 |
|---|---|---|
| Combined Costoclavicular and Suprascapular Nerve Block with Magnesium SulfateUnder ultrasound guidance and sterile technique, patients receive a single-shot suprascapular nerve block (SSNB) with 10 mL of 0.5% bupivacaine and 100 mg magnesium sulfate, followed by a costoclavicular brachial plexus block (CCB) with 10 mL of 0.5% bupivacaine and 100 mg magnesium sulfate (total volume: 20 mL bupivacaine 0.5% + 200 mg magnesium sulfate) administered prior to general anesthesia induction. | Procedure or surgery | Group A: Combined CCB-SSNB with Magnesium Sulfate |
| Interscalene Brachial Plexus Block with Magnesium SulfateUnder ultrasound guidance and sterile technique, patients receive a single-shot interscalene brachial plexus block (ISB) with 20 mL of 0.5% bupivacaine and 200 mg magnesium sulfate administered prior to general anesthesia induction. | Procedure or surgery | Group B: Interscalene Block with Magnesium Sulfate |
Primary outcome
Time to First Postoperative Rescue Analgesic Request
Time frame: Up to 48 hours postoperatively
Measured as the time (in hours) from the end of surgery (tracheal extubation) until the first administration of rescue analgesia, triggered when the patient requests pain relief or when the Numeric Rating Scale (NRS) pain score is >= 4 out of 10. Rescue analgesia consists of intravenous morphine.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Costoclavicular and Suprascapular Nerve Block with Magnesium Sulfate and Interscalene Brachial Plexus Block with Magnesium Sulfate in people with Postoperative Pain and Shoulder Arthroscopy, run by Assiut University.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Postoperative Rescue Analgesic Request (time frame: Up to 48 hours postoperatively). 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 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.