Post-operative PainPhase 2NCT07418671
Ultrasound Guided Lumbar Erector Spinae Block Using Bupivacaine - Magnesium Sulphate Versus Bupivacaine - Dexamethasone in Total Hip Replacement Surgery
A Phase 2 study testing Bupivacaine-Magnesium Sulphate, Bupivacaine-Dexamethasone and Bupivacaine-Saline in people with Post-operative Pain and Total Hip Arthroplasty (THA), run by Ain Shams University at 1 site in Egypt.
Trial summary
The current study was done to evaluate the effect of adding dexamethasone and magnesium sulfate to bupivacaine as adjuvants in an ultrasound-guided erector spinae block for patients undergoing total hip arthroplasty (THA), and to assess their impact on the timing of the first request for analgesia and on overall… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Post-operative Pain, Total Hip Arthroplasty (THA), Erector Spinae Plane Block
- What is being tested?
- Bupivacaine-Magnesium Sulphate, Bupivacaine-Dexamethasone and Bupivacaine-Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 25 Nov 2025
- Phase
- Phase 2
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical status: ASA 1 or 2.
- Age > 21
- Height 160 to 190 cm.
- Body Mass Index (BMI) < 40.
Who cannot join
- Refusing to participate in the study.
- Coagulopathy.
- Patients with history of drug allergies to study drugs.
- Inability to cooperate.
- Local disease as inflammation or infections at the site of puncture.
- Uncontrolled diabetes, significant cardiopulmonary disease, and mental illness.
Trial locations and contacts
1 site in 1 country.
About this study
The current study was done to evaluate the effect of adding dexamethasone and magnesium sulfate to bupivacaine as adjuvants in an ultrasound-guided erector spinae block for patients undergoing total hip arthroplasty (THA), and to assess their impact on the timing of the first request for analgesia and on overall postoperative analgesic requirements.
Read the detailed description
This study aimed to appraise the addition of dexamethasone and magnesium sulfate to bupivacaine as adjuvants by ultrasound-guided ESP block in patients having undergone total hip arthroplasty (THA) and its effect on the first analgesic request, total analgesic requirements.
This study was a prospective clinical study carried out to improve pain control after total hip arthroplasty (THA), which is a major orthopedic surgery often associated with significant postoperative discomfort. It is done to determine whether adding two commonly available medications-dexamethasone and magnesium sulfate-to the standard local anesthetic drug bupivacaine could enhance the effectiveness of the erector spinae plane (ESP) block.
The study included adult patients scheduled for elective total hip replacement surgery. All participants were carefully evaluated before enrollment to ensure they met specific inclusion criteria, such as appropriate age range, general health status, and absence of contraindications to regional anesthesia. Patients with conditions like known allergy to study drugs, severe coagulation problems, local infection at the injection site, or major systemic illness were excluded in order to maintain safety and reliability.
Participants were randomly divided into three groups. Each group received an ESP block under ultrasound guidance at the lumbar level at the end of surgery. Ultrasound was used to accurately identify the muscles, bones, and nerves of the lower back so that the anesthetic solution could be injected in the correct tissue plane. The groups are:
One group received bupivacaine plus saline (control group). A second group received bupivacaine with dexamethasone. A third group received bupivacaine with magnesium sulfate.
Following completion of the ESP block, patients were placed in a comfortable supine position and were subjected to continuous clinical observation to detect any procedure-related immediate complications. In the postoperative period, all study groups received the same standardized analgesic protocol and routine perioperative management to ensure uniformity of care and minimize bias. Assessment of pain severity was performed at predetermined regular intervals using validated scoring systems such as the Visual Analogue Scale. The precise duration of analgesia was determined by documenting the time to first postoperative analgesic request for each patient. Nursing staff recorded all additional analgesic medications administered during the first 24 hours after surgery, including total opioid consumption and rescue non-opioid analgesic requirements. Hemodynamic parameters, level of sedation, and possible adverse effects-such as postoperative nausea and vomiting, dizziness, local discomfort, hematoma formation, or signs of infection at the puncture site-were carefully monitored and documented. All collected clinical and laboratory data were subsequently coded and prepared for detailed statistical analysis in order to compare the efficacy of the different bupivacaine-adjuvant combinations in enhancing postoperative pain control after total hip arthroplasty.
- Being tested
- Bupivacaine-Magnesium Sulphate, Bupivacaine-Dexamethasone, Bupivacaine-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.
Bupivacaine-Magnesium SulphateCombination product
Bupivacaine plus Magnesium Sulphate (MgSO4) as adjuvant
Bupivacaine-DexamethasoneCombination product
Bupivacaine plus Dexamethasone as adjuvant
Bupivacaine-SalineCombination product
Bupivacaine plus Saline as control
| Study group | Role | What they receive |
|---|---|---|
| Group BS (Bupivacaine-Saline): control | Active comparator | Group BS: The group will receive 30 ml 0.25% bupivacaine plus 5 ml normal saline. Receives: Combination Product: Bupivacaine-Saline |
| Group BM (Bupivacaine-Magnesium) | Active comparator | the group will receive 30 mL 0.25% bupivacaine plus 5ml of 10% MgSO4 Receives: Combination Product: Bupivacaine-Magnesium Sulphate |
| Group BD (Bupivacaine-Dexamethasone) | Active comparator | The group will receive 30 mL 0.25% bupivacaine plus 5 ml normal saline containing 8 mg dexamethasone. Receives: Combination Product: Bupivacaine-Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative analgesia duration
Post-operative analgesia duration, which is measured as the time to the first analgesic request by the patient
Measured: 24-HOURS
Secondary outcomes (5)
Total postoperative opioid consumption
the total dose of pethidine required by the patient within the first 12 hours after surgery
Measured: 12 HOURS
Pain Intensity using Visual Analogue Pain Scale (VAS)
Assessment of pain levels using the Visual Analogue Pain Scale every 2 hours for a total of 24 hours
Measured: 24-HOURS
Hemodynamic stability
Monitoring for any adverse effects on heart rate
Measured: 24-HOURS
Hemodynamic stability
Monitoring for any adverse effects on mean arterial blood pressure
Measured: 24-HOURS
Postoperative complications
Monitoring for issues such as bleeding, hematoma, or local anesthetic toxicity over the first 24 hours
Measured: 24-HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 May 2025
- Primary completion1 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf A Abouslemah, PhD, Study chair, Ain Shams UniversityAhmed F Abdelraouf, PhD, Study director, Ain Shams UniversitySameh A Hosny, MSc, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418671
- Sponsor's protocol ID
- MS 222/2025
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Farahata TEM, El-Bahnasawy NS, Heikal O, El-Mohaimen A. Efficacy of adding dexamethasone to levobupivacaine in erector spinae block for total hip arthroplasty. Egypt J Hosp Med. 2022;87(1):2184-2189.
Reysner T, Kowalski G, Resyner M, Geisler-Wojciechowska A, Grochowicka M, et al. Erector spinae plane block for pain management after total hip arthroplasty: a systematic review and meta-analysis. Chir Narzadow Ruchu Ortop Pol. 2024;89(4):170-177.
Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study. Anesth Essays Res. 2018 Oct-Dec;12(4):825-831. doi: 10.4103/aer.AER_142_18.
PubMed 30662115Hines K, Davis E, O'Shea K, Vogl K. Rehabilitation after total hip arthroplasty. In: Essentials in Total Hip Arthroplasty. Boca Raton (FL): CRC Press; 2024. p. 269-275.
Ahmed Mostafa Aref F, Abdelaziz NM, Elazazzi HM, Fahmy NG. Effect of addition of magnesium sulfate and dexamethasone versus plain bupivacaine in ultrasound-guided erector spinae plane block in pediatrics undergoing repair of inguinal hernia. Egypt J Anaesth. 2023;39(1):906-911.
Abd El Rahman A, Mohamed M, Hassan A, Mohammed H. Comparative study between dexamethasone-bupivacaine versus magnesium sulfate-bupivacaine for postoperative analgesia. Sohag Med J. 2017;21(3):589-595.
Desai N, Kirkham KR, Albrecht E. Local anaesthetic adjuncts for peripheral regional anaesthesia: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1:100-109. doi: 10.1111/anae.15245.
PubMed 33426668Ban G, Long J, Yan K, Li Q, Huang X, Wei X, Xie F. A New Nanocomposite for Inducing Demineralized Dentin Remineralization. Int J Nanomedicine. 2025 Feb 1;20:1335-1349. doi: 10.2147/IJN.S500283. eCollection 2025.
PubMed 39911261Ratnaparkhi R, Javellana M, Jewell A, Spoozak L. Evaluation of Homologous Recombination Deficiency in Ovarian Cancer. Curr Treat Options Oncol. 2024 Feb;25(2):237-260. doi: 10.1007/s11864-024-01176-6. Epub 2024 Feb 1.
PubMed 38300479Zhang Y, Dong C, Zheng C, Lv Z, Tian RN, Wang M, Chen J, Wang D, Zhang X, Mao Z. Soft-in-Rigid Strategy Promoting Rapid and High-Capacity Lithium Storage by Chemical Scissoring. Inorg Chem. 2024 Jun 17;63(24):11406-11415. doi: 10.1021/acs.inorgchem.4c01493. Epub 2024 Jun 4.
PubMed 38835144Ingendahl M, Vogel T, Topolinski S. The articulatory in-out effect: replicable, but inexplicable. Trends Cogn Sci. 2022 Jan;26(1):8-10. doi: 10.1016/j.tics.2021.10.008. Epub 2021 Oct 30.
PubMed 34728149Wisniewska A, Czepiel K, Stachowicz A, Pomierny B, Kus K, Kiepura A, Stachyra K, Surmiak M, Madej J, Olszanecki R, Suski M. The antiatherosclerotic action of 1G244 - An inhibitor of dipeptidyl peptidases 8/9 - is mediated by the induction of macrophage death. Eur J Pharmacol. 2023 Apr 5;944:175566. doi: 10.1016/j.ejphar.2023.175566. Epub 2023 Feb 3.
PubMed 36739078de la Garza CGV, Narvaez WEV, Rodriguez LDS, Fomine S. Novel 2D allotropic forms and nanoflakes of silicon, phosphorus, and germanium: a computational study. J Mol Model. 2021 Apr 28;27(5):142. doi: 10.1007/s00894-021-04775-4.
PubMed 33909167Chen IY, Chang CW, Fittschen C, Luo PL. Accurate Kinetic Studies of OH + HO2 Radical-Radical Reaction through Direct Measurement of Precursor and Radical Concentrations with High-Resolution Time-Resolved Dual-Comb Spectroscopy. J Phys Chem Lett. 2024 Apr 11;15(14):3733-3739. doi: 10.1021/acs.jpclett.4c00494. Epub 2024 Mar 28.
PubMed 38547368Miele E, Abballe L, Spinelli GP, Besharat ZM, Catanzaro G, Chiacchiarini M, Vacca A, Po A, Capalbo C, Ferretti E. BRAF mutant colorectal cancer: ErbB2 expression levels as predictive factor for the response to combined BRAF/ErbB inhibitors. BMC Cancer. 2020 Feb 17;20(1):129. doi: 10.1186/s12885-020-6586-0.
PubMed 32066410
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Lumbar Erector Spinae Block Using Bupivacaine - Magnesium Sulphate Versus Bupivacaine - Dexamethasone in Total Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT07418671
- Acronym / sponsor ID
- MS 222/2025
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 18 Feb 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.
The current study was done to evaluate the effect of adding dexamethasone and magnesium sulfate to bupivacaine as adjuvants in an ultrasound-guided erector spinae block for patients undergoing total hip arthroplasty (THA), and to assess their impact on the timing of the first request for analgesia and on overall postoperative analgesic requirements.
Detailed description
This study aimed to appraise the addition of dexamethasone and magnesium sulfate to bupivacaine as adjuvants by ultrasound-guided ESP block in patients having undergone total hip arthroplasty (THA) and its effect on the first analgesic request, total analgesic requirements.
This study was a prospective clinical study carried out to improve pain control after total hip arthroplasty (THA), which is a major orthopedic surgery often associated with significant postoperative discomfort. It is done to determine whether adding two commonly available medications-dexamethasone and magnesium sulfate-to the standard local anesthetic drug bupivacaine could enhance the effectiveness of the erector spinae plane (ESP) block.
The study included adult patients scheduled for elective total hip replacement surgery. All participants were carefully evaluated before enrollment to ensure they met specific inclusion criteria, such as appropriate age range, general health status, and absence of contraindications to regional anesthesia. Patients with conditions like known allergy to study drugs, severe coagulation problems, local infection at the injection site, or major systemic illness were excluded in order to maintain safety and reliability.
Participants were randomly divided into three groups. Each group received an ESP block under ultrasound guidance at the lumbar level at the end of surgery. Ultrasound was used to accurately identify the muscles, bones, and nerves of the lower back so that the anesthetic solution could be injected in the correct tissue plane. The groups are:
One group received bupivacaine plus saline (control group). A second group received bupivacaine with dexamethasone. A third group received bupivacaine with magnesium sulfate.
Following completion of the ESP block, patients were placed in a comfortable supine position and were subjected to continuous clinical observation to detect any procedure-related immediate complications. In the postoperative period, all study groups received the same standardized analgesic protocol and routine perioperative management to ensure uniformity of care and minimize bias. Assessment of pain severity was performed at predetermined regular intervals using validated scoring systems such as the Visual Analogue Scale. The precise duration of analgesia was determined by documenting the time to first postoperative analgesic request for each patient. Nursing staff recorded all additional analgesic medications administered during the first 24 hours after surgery, including total opioid consumption and rescue non-opioid analgesic requirements. Hemodynamic parameters, level of sedation, and possible adverse effects-such as postoperative nausea and vomiting, dizziness, local discomfort, hematoma formation, or signs of infection at the puncture site-were carefully monitored and documented. All collected clinical and laboratory data were subsequently coded and prepared for detailed statistical analysis in order to compare the efficacy of the different bupivacaine-adjuvant combinations in enhancing postoperative pain control after total hip arthroplasty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group BS (Bupivacaine-Saline): control | Active comparator | Combination Product: Bupivacaine-SalineGroup BS: The group will receive 30 ml 0.25% bupivacaine plus 5 ml normal saline. |
| Group BM (Bupivacaine-Magnesium) | Active comparator | Combination Product: Bupivacaine-Magnesium Sulphatethe group will receive 30 mL 0.25% bupivacaine plus 5ml of 10% MgSO4 |
| Group BD (Bupivacaine-Dexamethasone) | Active comparator | Combination Product: Bupivacaine-DexamethasoneThe group will receive 30 mL 0.25% bupivacaine plus 5 ml normal saline containing 8 mg dexamethasone. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physical status: ASA 1 or 2.
- Age > 21
- Height 160 to 190 cm.
- Body Mass Index (BMI) < 40.
Key exclusion criteria (6 listed)
- Refusing to participate in the study.
- Coagulopathy.
- Patients with history of drug allergies to study drugs.
- Inability to cooperate.
- Local disease as inflammation or infections at the site of puncture.
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 SulphateBupivacaine plus Magnesium Sulphate (MgSO4) as adjuvant | Combination product | Group BM (Bupivacaine-Magnesium) |
| Bupivacaine-DexamethasoneBupivacaine plus Dexamethasone as adjuvant | Combination product | Group BD (Bupivacaine-Dexamethasone) |
| Bupivacaine-SalineBupivacaine plus Saline as control | Combination product | Group BS (Bupivacaine-Saline): control |
Primary outcome
Post-operative analgesia duration
Time frame: 24-HOURS
Post-operative analgesia duration, which is measured as the time to the first analgesic request by the patient
5 secondary outcomes
Total postoperative opioid consumption
Time frame: 12 HOURS
Pain Intensity using Visual Analogue Pain Scale (VAS)
Time frame: 24-HOURS
Hemodynamic stability
Time frame: 24-HOURS
Hemodynamic stability
Time frame: 24-HOURS
Postoperative complications
Time frame: 24-HOURS
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 18 Feb 2026.
- Results publicationFarahata TEM, El-Bahnasawy NS, Heikal O, El-Mohaimen A. Efficacy of adding dexamethasone to levobupivacaine in erector spinae block for total hip arthroplasty. Egypt J Hosp Med. 2022;87(1):2184-2189.
- Results publicationReysner T, Kowalski G, Resyner M, Geisler-Wojciechowska A, Grochowicka M, et al. Erector spinae plane block for pain management after total hip arthroplasty: a systematic review and meta-analysis. Chir Narzadow Ruchu Ortop Pol. 2024;89(4):170-177.
- Results publication: PubMed 30662115Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study. Anesth Essays Res. 2018 Oct-Dec;12(4):825-831. doi: 10.4103/aer.AER_142_18.
- Results publicationHines K, Davis E, O'Shea K, Vogl K. Rehabilitation after total hip arthroplasty. In: Essentials in Total Hip Arthroplasty. Boca Raton (FL): CRC Press; 2024. p. 269-275.
- Results publicationAhmed Mostafa Aref F, Abdelaziz NM, Elazazzi HM, Fahmy NG. Effect of addition of magnesium sulfate and dexamethasone versus plain bupivacaine in ultrasound-guided erector spinae plane block in pediatrics undergoing repair of inguinal hernia. Egypt J Anaesth. 2023;39(1):906-911.
- Results publicationAbd El Rahman A, Mohamed M, Hassan A, Mohammed H. Comparative study between dexamethasone-bupivacaine versus magnesium sulfate-bupivacaine for postoperative analgesia. Sohag Med J. 2017;21(3):589-595.
- Results publication: PubMed 33426668Desai N, Kirkham KR, Albrecht E. Local anaesthetic adjuncts for peripheral regional anaesthesia: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1:100-109. doi: 10.1111/anae.15245.
- Results publication: PubMed 39911261Ban G, Long J, Yan K, Li Q, Huang X, Wei X, Xie F. A New Nanocomposite for Inducing Demineralized Dentin Remineralization. Int J Nanomedicine. 2025 Feb 1;20:1335-1349. doi: 10.2147/IJN.S500283. eCollection 2025.
- Results publication: PubMed 38300479Ratnaparkhi R, Javellana M, Jewell A, Spoozak L. Evaluation of Homologous Recombination Deficiency in Ovarian Cancer. Curr Treat Options Oncol. 2024 Feb;25(2):237-260. doi: 10.1007/s11864-024-01176-6. Epub 2024 Feb 1.
- Results publication: PubMed 38835144Zhang Y, Dong C, Zheng C, Lv Z, Tian RN, Wang M, Chen J, Wang D, Zhang X, Mao Z. Soft-in-Rigid Strategy Promoting Rapid and High-Capacity Lithium Storage by Chemical Scissoring. Inorg Chem. 2024 Jun 17;63(24):11406-11415. doi: 10.1021/acs.inorgchem.4c01493. Epub 2024 Jun 4.
- Results publication: PubMed 34728149Ingendahl M, Vogel T, Topolinski S. The articulatory in-out effect: replicable, but inexplicable. Trends Cogn Sci. 2022 Jan;26(1):8-10. doi: 10.1016/j.tics.2021.10.008. Epub 2021 Oct 30.
- Results publication: PubMed 36739078Wisniewska A, Czepiel K, Stachowicz A, Pomierny B, Kus K, Kiepura A, Stachyra K, Surmiak M, Madej J, Olszanecki R, Suski M. The antiatherosclerotic action of 1G244 - An inhibitor of dipeptidyl peptidases 8/9 - is mediated by the induction of macrophage death. Eur J Pharmacol. 2023 Apr 5;944:175566. doi: 10.1016/j.ejphar.2023.175566. Epub 2023 Feb 3.
- 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.
Ashraf A Abouslemah, PhD study chair
Ain Shams University
Ahmed F Abdelraouf, PhD study director
Ain Shams University
Sameh A Hosny, MSc principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine-Magnesium Sulphate, Bupivacaine-Dexamethasone and Bupivacaine-Saline in people with Post-operative Pain and Total Hip Arthroplasty (THA), run by Ain Shams 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 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: finished, as of the sponsor's last update on 18 Feb 2026. 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 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.
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?
Post-operative analgesia duration (time frame: 24-HOURS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07418671, which also lists 24 linked publications.
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 18 Feb 2026.