Pain Score ReductionPhase 2/3Mgso4NCT06956950
Magnesium Sulfate in Addition to Bupivacaine in Ultrasound-guided Transmuscular Quadratus Lumborum Block for Post-Operative Analgesia After Total Hip Arthroplasty
A Phase 2/3 study testing Bupivacaine + Magnesium sulfate and Bupivacaine + saline in people with Pain Score Reduction, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this clinical trial is to evaluate the efficacy of adding magnesium sulfate to bupivacaine in ultrasound-guided transmuscular quadratus lumborum block for postoperative analgesia in adult patients underdoing hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Score Reduction
- What is being tested?
- Bupivacaine + Magnesium sulfate and Bupivacaine + saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- May 2025to Nov 2025
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- American Society of Anesthesiology (ASA) class I-III
- Undergoing hip arthroplasty .
Who cannot join
- Patient refusal.
- Body mass index (BMI) > 40 Kg/m2.
- Allergy to local anesthetics or magnesium sulphate.
- coexisting coagulopathy.
- Local infection at puncture site.
- Severe renal impairment ( eGFR < 30 ml/min)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine
Tanta, El-Gharbia, 31527
Mohammed Hussain Mahmoud, professor, +20403317236, tanta_unv@unv.tanta.edu.eg
Mostafa Mohammad Abdelsattar Elbagoury, MD
About this study
Official title: Efficacy of Adding Magnesium Sulfate to Bupivacaine in Ultrasound-guided Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Patients Underdoing Hip Arthroplasty
The aim of this clinical trial is to evaluate the efficacy of adding magnesium sulfate to bupivacaine in ultrasound-guided transmuscular quadratus lumborum block for postoperative analgesia in adult patients underdoing hip arthroplasty. The main questions it aims to answer are:
- Does Magnesium sulphate lower Pain score (VAS) postoperatively.
- Does Magnesium sulphate lowerTotal opioid consumption postoperatively. and What side effects do participants have when taking Magnesium sulphate? Researchers will compare Magnesium sulphate to a placebo (a look-alike substance that contains no drug) to see if Magnesium sulphate works to lower pain score.
Read more
Participants will:
- Take with have ultrasound-guided transmuscular quadratus lumborum block after surgery using bupivacaine with Magnesium sulphate or with placebo
- Followed up 48 hours postoperatively to monitor pain score or any reported side effect.
Read the detailed description
The quadratus lumborum block (QLB) is an abdominal wall fascial block plane block described for providing perioperative analgesia for abdominal, hip and lower limb surgeries . Opioid-sparing analgesic treatments for hip arthroplasty such as lumbar plexus and femoral nerve blocks, are effective but they carry a high risk of undesirable lower limb motor or muscle weakness. Fascia iliaca block, on the other hand, does not consistently provide adequate pain relief. Quadratus lumborum (QL) block is a relatively new truncal regional block technique that provides effective pain control after upper and lower abdominal surgeries. ersalis fascia laterally. The anterior QL block was also classified as transmuscular approach (in between QL and PM muscles) in earlier studies . Local anesthetic injected between the QL muscle and anterior layer of the thoracolumbar fascia can potentially spread to the thoracic paravertebral (PVB) space.
Magnesium plays an important role in the physiological function of the human body. A large number of studies have reported the safetyand effectiveness of adding magnesium sulfate in various regional anesthesia techniques . Therefore, this prospective randomized controlled study to compare the analgesic efficacy of combining magnesium sulfate with bupivacaine in QLB.
- Conditions
- Pain Score Reduction
- Being tested
- Bupivacaine + Magnesium sulfate, Bupivacaine + saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine + Magnesium sulfateDrug
ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml 10% magnesium sulfate
Bupivacaine + salineDrug
ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml normal saline
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine /MgSo4 | Active comparator | patients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus MgSo4 after surgery Receives: Drug: Bupivacaine + Magnesium sulfate |
| bupivacaine/saline | Active comparator | patients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus saline after surgery Receives: Drug: Bupivacaine + saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
postopeative pain Score
The degree of pain will be assessed after surgery by Visual Analogue Score (score for the severity of pain in the range 0-10, where 0 = no pain and 10 = severe pain) at 6 , 12 , 24 , 48 hours postoperatively.
Measured: 48 hours postoperatively
Secondary outcomes (2)
Total opioid consumption
total morphine consumption after surgery
Measured: 48 hours postoperatively
Time to first rescue analgsic request
Measured: 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 posted4 May 2025
- Study startMay 2025 (estimated)
- Primary completion9 Oct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Score ReductionStudies of the same condition, open and under way.
- More trials run by Tanta 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml 10% magnesium sulfate
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohammad Abdelsattar Elbagoury, Tanta University
- Investigators
- Mostafa Mohammad Abdelsattar Elbagoury, MD, Principal investigator, lecturer of anesthesia and surgical ICU and pain medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956950
- Sponsor's protocol ID
- 36264PR1128/3/25
- Acronym
- Mgso4
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Magnesium Sulfate to Bupivacaine in Ultrasound-guided Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Patients Underdoing Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06956950
- Acronym / sponsor ID
- Mgso4 / 36264PR1128/3/25
- Conditions
- Pain Score Reduction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- 9 Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 4 May 2025 (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.
The aim of this clinical trial is to evaluate the efficacy of adding magnesium sulfate to bupivacaine in ultrasound-guided transmuscular quadratus lumborum block for postoperative analgesia in adult patients underdoing hip arthroplasty. The main questions it aims to answer are:
- Does Magnesium sulphate lower Pain score (VAS) postoperatively.
- Does Magnesium sulphate lowerTotal opioid consumption postoperatively. and What side effects do participants have when taking Magnesium sulphate? Researchers will compare Magnesium sulphate to a placebo (a look-alike substance that contains no drug) to see if Magnesium sulphate works to lower pain score.
Participants will:
- Take with have ultrasound-guided transmuscular quadratus lumborum block after surgery using bupivacaine with Magnesium sulphate or with placebo
- Followed up 48 hours postoperatively to monitor pain score or any reported side effect.
Detailed description
The quadratus lumborum block (QLB) is an abdominal wall fascial block plane block described for providing perioperative analgesia for abdominal, hip and lower limb surgeries . Opioid-sparing analgesic treatments for hip arthroplasty such as lumbar plexus and femoral nerve blocks, are effective but they carry a high risk of undesirable lower limb motor or muscle weakness. Fascia iliaca block, on the other hand, does not consistently provide adequate pain relief. Quadratus lumborum (QL) block is a relatively new truncal regional block technique that provides effective pain control after upper and lower abdominal surgeries. ersalis fascia laterally. The anterior QL block was also classified as transmuscular approach (in between QL and PM muscles) in earlier studies . Local anesthetic injected between the QL muscle and anterior layer of the thoracolumbar fascia can potentially spread to the thoracic paravertebral (PVB) space.
Magnesium plays an important role in the physiological function of the human body. A large number of studies have reported the safetyand effectiveness of adding magnesium sulfate in various regional anesthesia techniques . Therefore, this prospective randomized controlled study to compare the analgesic efficacy of combining magnesium sulfate with bupivacaine in QLB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- ultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml 10% magnesium sulfate
| Arm | Type | Receives |
|---|---|---|
| bupivacaine /MgSo4 | Active comparator | Drug: Bupivacaine + Magnesium sulfatepatients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus MgSo4 after surgery |
| bupivacaine/saline | Active comparator | Drug: Bupivacaine + salinepatients will receive ipsilateral single-shot of ultrasound-guided transmuscular quadratus lumborum block using bupivacaine plus saline after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- American Society of Anesthesiology (ASA) class I-III
- Undergoing hip arthroplasty .
Key exclusion criteria (6 listed)
- Patient refusal.
- Body mass index (BMI) > 40 Kg/m2.
- Allergy to local anesthetics or magnesium sulphate.
- coexisting coagulopathy.
- Local infection at puncture site.
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 |
|---|---|---|
| Bupivacaine + Magnesium sulfateultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml 10% magnesium sulfate | Drug | bupivacaine /MgSo4 |
| Bupivacaine + salineultrasound-guided transmuscular quadratus lumborum block using 25 ml of 0.25% bupivacaine + 5 ml normal saline | Drug | bupivacaine/saline |
Primary outcome
postopeative pain Score
Time frame: 48 hours postoperatively
The degree of pain will be assessed after surgery by Visual Analogue Score (score for the severity of pain in the range 0-10, where 0 = no pain and 10 = severe pain) at 6 , 12 , 24 , 48 hours postoperatively.
2 secondary outcomes
Total opioid consumption
Time frame: 48 hours postoperatively
Time to first rescue analgsic request
Time frame: 48 hours postoperatively
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 11 May 2025.
- Individual participant dataSharing planned: No
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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.
Mostafa Mohammad Abdelsattar Elbagoury, MD principal investigator
lecturer of anesthesia and surgical ICU and pain medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bupivacaine + Magnesium sulfate and Bupivacaine + saline in people with Pain Score Reduction, run by Tanta 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 May 2025. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Mostafa Mohammad Abdelsattar Elbagoury, MD (+201116297741, mostafa.elbagoury@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postopeative pain Score (time frame: 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 11 May 2025.