Post Operative PainPhase 3NCT06520475
Efficacy of Bupivacaine-magnesium Combination Versus Bupivacaine Alone in Genicular Nerve Block
A Phase 3 study testing genicular nerve block using bupivacaine and magnesium and genicular nerve block using bupivacaine and normal saline in people with Post Operative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
It is proved that the addition of magnesium sulfate to local anesthetics for neuraxial anesthesia improves the quality of analgesia and prolongs the duration of anesthesia . In-vitro and in-vivo studies have demonstrated that magnesium enhances the local anesthetics effect on peripheral nerves . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- genicular nerve block using bupivacaine and magnesium and genicular nerve block using bupivacaine and normal saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 7 Oct 2025
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist (ASA) I or II physical status.
- Between 18 and 70 years of age.
- Both genders.
- Patients undergoing total knee replacement surgery.
Who cannot join
- Patient refusal.
- ASA Ⅲ and Ⅳ patients.
- Known allergy to the study drugs.
- Hypermagnesemia.
- Central or peripheral neurological disease.
- Pregnancy.
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- Drug or alcohol abuse.
- Localized infection at the site of the block.
- Bleeding disorder (platelets count less than 100,000 or international normalized ratio more than 1.4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Bupivacaine-magnesium Combination Versus Bupivacaine Alone in Genicular Nerve Block in Total Knee Replacement Surgeries: a Randomized Controlled Study
It is proved that the addition of magnesium sulfate to local anesthetics for neuraxial anesthesia improves the quality of analgesia and prolongs the duration of anesthesia . In-vitro and in-vivo studies have demonstrated that magnesium enhances the local anesthetics effect on peripheral nerves .
No previous studies were conducted on magnesium sulfate as an adjuvant to the local anesthetic in genicular nerve block. Hence, this study will be conducted to assess analgesic efficacy of magnesium sulfate when added to bupivacaine in ultrasound guided genicular nerve block
- Conditions
- Post Operative Pain
- Being tested
- genicular nerve block using bupivacaine and magnesium, genicular nerve block using bupivacaine and normal saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genicular nerve block using bupivacaine and magnesiumProcedure or surgery
The patients will receive 13 ml of 0.5% bupivacaine and 2 ml of 10% magnesium sulfate
genicular nerve block using bupivacaine and normal salineProcedure or surgery
The patients will receive 13 ml of 0.5% bupivacaine and 2 ml of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine + Magnesium | Active comparator | Not described Receives: Procedure: genicular nerve block using bupivacaine and magnesium |
| Bupivacaine + Normal saline | Placebo comparator | Not described Receives: Procedure: genicular nerve block using bupivacaine and normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
Pain will be assessed with Numerical Rating Scale. Patients will be asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.
Measured: 24 hours post-operatively
Secondary outcomes (3)
First request for analgesia
Measured: 24 hours post-operatively
Total opioid consumption
Measured: 24 hours post-operatively
Patient satisfaction
Patient satisfaction will be assessed at 48 h postoperatively (0 = very dissatisfied, 2 = somewhat dissatisfied, 3 = somewhat satisfied, 4 = very satisfied)
Measured: 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Aug 2024
- Primary completion15 Sep 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElKhalik Mahmoud Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520475
- Sponsor's protocol ID
- N-157-2024
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bupivacaine-magnesium Combination Versus Bupivacaine Alone in Genicular Nerve Block in Total Knee Replacement Surgeries: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06520475
- Acronym / sponsor ID
- N-157-2024
- Conditions
- Post Operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 25 Jul 2024 (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.
It is proved that the addition of magnesium sulfate to local anesthetics for neuraxial anesthesia improves the quality of analgesia and prolongs the duration of anesthesia . In-vitro and in-vivo studies have demonstrated that magnesium enhances the local anesthetics effect on peripheral nerves .
No previous studies were conducted on magnesium sulfate as an adjuvant to the local anesthetic in genicular nerve block. Hence, this study will be conducted to assess analgesic efficacy of magnesium sulfate when added to bupivacaine in ultrasound guided genicular nerve block
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine + Magnesium | Active comparator | Procedure: genicular nerve block using bupivacaine and magnesium |
| Bupivacaine + Normal saline | Placebo comparator | Procedure: genicular nerve block using bupivacaine and normal saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologist (ASA) I or II physical status.
- Between 18 and 70 years of age.
- Both genders.
- Patients undergoing total knee replacement surgery.
Key exclusion criteria (9 listed)
- Patient refusal.
- ASA Ⅲ and Ⅳ patients.
- Known allergy to the study drugs.
- Hypermagnesemia.
- Central or peripheral neurological disease.
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 |
|---|---|---|
| genicular nerve block using bupivacaine and magnesiumThe patients will receive 13 ml of 0.5% bupivacaine and 2 ml of 10% magnesium sulfate | Procedure or surgery | Bupivacaine + Magnesium |
| genicular nerve block using bupivacaine and normal salineThe patients will receive 13 ml of 0.5% bupivacaine and 2 ml of normal saline | Procedure or surgery | Bupivacaine + Normal saline |
Primary outcome
Numerical Rating Scale
Time frame: 24 hours post-operatively
Pain will be assessed with Numerical Rating Scale. Patients will be asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.
3 secondary outcomes
First request for analgesia
Time frame: 24 hours post-operatively
Total opioid consumption
Time frame: 24 hours post-operatively
Patient satisfaction
Time frame: 24 hours post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing genicular nerve block using bupivacaine and magnesium and genicular nerve block using bupivacaine and normal saline in people with Post Operative Pain, run by Cairo 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 17 Nov 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical Rating Scale (time frame: 24 hours post-operatively). 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 17 Nov 2025.