Kidney DiseasesESP-QLB-PedsNCT07346417
Erector Spinae Plane Block Versus Quadratus Lumborum Block
A study testing Quadratus lumborum block teqnique and Erector spinae plane block Technique in people with Kidney Diseases, run by Assiut University.
Trial summary
To compare the efficacy and safety of ultrasound-guided ESPB versus QLB for post-operative analgesia in children undergoing kidney surgery. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Quadratus lumborum block teqnique and Erector spinae plane block Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2025to 30 Mar 2028
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of both sexes, aged 2-12 years, with ASA physical status I-II scheduled for elective unilateral kidney surgery will be eligible.
Who cannot join
- Infection at the site of needle insertion
- Allergy to local anesthetics
- Parental refusal of consent
About this study
Official title: Erector Spinae Plane Block Versus Quadratus Lumborum Block for Post Operative Analgesia in Pediatric Kidney Surgery
To compare the efficacy and safety of ultrasound-guided ESPB versus QLB for post-operative analgesia in children undergoing kidney surgery.
Read the detailed description
The management of postoperative pain in pediatric kidney surgery is a critical component of enhanced recovery and improved patient outcomes. Effective analgesia minimizes opioid consumption and their associated side effects, facilitating early mobilization and discharge. Regional anesthesia techniques have gained prominence as opioid-sparing modalities in pediatric patients, with the erector spinae plane block (ESPB) and quadratus lumborum block (QLB) increasingly used in abdominal and renal surgeries.
The erector spinae plane block is a fascial plane block targeting the dorsal rami of spinal nerves, providing extensive analgesia for thoracic and abdominal procedures. It is considered relatively easy and safe to perform under ultrasound guidance and has been associated with effective postoperative analgesia and reduced opioid requirements in pediatric renal surgery. Additional advantages include shorter block performance time and a lower incidence of postoperative nausea and vomiting compared with other regional techniques.
The quadratus lumborum block involves local anesthetic deposition near the quadratus lumborum muscle and can be performed using different approaches, such as anterior and transmuscular techniques. These approaches provide both somatic and visceral analgesia for lower abdominal and renal surgeries. Continuous quadratus lumborum block has demonstrated effective postoperative pain control, reduced need for rescue analgesia, and minimal adverse events in pediatric renal procedures. It is also recognized for its favorable safety profile and its contribution to improved quality of recovery.
Although both ESPB and QLB are effective regional techniques for pediatric postoperative analgesia, studies comparing their efficacy have reported variable results. Some investigations have shown comparable pain scores and opioid consumption between the two blocks, while others suggest potential advantages of one technique over the other in terms of analgesic duration, side-effect profile, or patient satisfaction.
Pain assessment in pediatric patients remains challenging because of differences in age, cognitive development, and communication abilities. This necessitates the use of objective pain scoring systems and careful perioperative analgesic planning. Consequently, evaluating and comparing the analgesic efficacy and safety of these two regional blocks in pediatric kidney surgery is of particular clinical importance.
The rationale of this study is to provide direct comparative evidence on the effectiveness and safety of ultrasound-guided ESPB versus QLB for postoperative analgesia in pediatric kidney surgery. Clarifying which technique offers superior analgesic control with fewer side effects may help optimize perioperative pain management protocols and improve postoperative outcomes. This study aims to assess postoperative pain scores, opioid consumption, block-related complications, and recovery quality in order to guide anesthetic decision-making in pediatric renal surgery
- Conditions
- Kidney Diseases
- Being tested
- Quadratus lumborum block teqnique, Erector spinae plane block Technique
- Keywords
- Pediatric- kidney-surgery
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum block teqniqueProcedure or surgery
All blocks were performed under ultrasound guidance. A high-frequency linear probe was positioned in the mid-axillary line cranial to the iliac crest to identify the abdominal wall muscles (external oblique, internal oblique, and transversus abdominis). The probe was then moved dorsally until the transversus abdominis muscle became aponeurotic, which was followed medially to visualize the quadratus lumborum (QL) muscle at its attachment to the L4 transverse process adjacent to the psoas muscle.
Using an in-plane anterior-to-posterior approach, the block needle was advanced toward the anterior border of the QL muscle. After confirming the needle tip position with a 1 ml saline test injection, 0.5 ml/kg of 0.25% bupivacaine was administered. Bilateral injections were performed for midline incisions, while unilateral injections were used for paramedian incisions.
Erector spinae plane block TechniqueProcedure or surgery
Ultrasound-guided erector spinae plane block performed at the thoracic level using a single-shot technique in pediatric patients undergoing kidney surgery to provide postoperative analgesia. Local anesthetic is injected deep to the erector spinae muscle over the transverse process with expected craniocaudal spread.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block | Experimental | Ultrasound-guided erector spinae plane block performed at the thoracic level using a multi-shot technique after completion of surgery and before extubation for pediatric kidney surgery to provide postoperative analgesia. Receives: Procedure: Quadratus lumborum block teqnique; Procedure: Erector spinae plane block Technique |
| Quadratus lumborum block | Active comparator | Ultrasound-guided quadratus lumborum block performed using a multi-shot technique, after completion of surgery and before extubation of anesthesia for pediatric kidney surgery to provide postoperative analgesia. Receives: Procedure: Quadratus lumborum block teqnique; Procedure: Erector spinae plane block Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia
measured from extubation until the first request/administration of analgesia, in hours
Measured: 24 hours
Secondary outcomes (6)
Total analgesic consumption
Total 24-hour postoperative analgesic consumption (mg/kg paracetamol, µg/kg fentanyl).
Measured: 24 hours
Postoperative pain score
FLACC pain score assessed at 0, 1, 2, 6, 12, and 24 hours postoperatively.
Measured: 24 hours
Incidence of postoperative nausea and vomiting
Incidence of PONV within 24 hours postoperatively.
Measured: 24 hours
Block-related complications
Incidence of block-related complications.
Measured: 24 hours
Postoperative hemodynamic stability
Changes in heart rate and blood pressure >20% from baseline.
Measured: 24 hours
Parent satisfaction
Parent satisfaction measured using a 5-point Likert scale.
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 posted16 Jan 2026
- Study start25 Dec 2025 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr omar abdulrazzaq omar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346417
- Sponsor's protocol ID
- Pediatric-Block-Study-2025
- Acronym
- ESP-QLB-Peds
- Status last verified
- Jan 2026
- First submitted
- 25 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu X, He H, Zhao L, Zeng Z, Yuan J. Case Report: Gastric cancer with chondromyxoid matrix similar matrix-producing metaplastic breast carcinoma: report of an undescribed entity. Front Oncol. 2023 May 19;13:1087241. doi: 10.3389/fonc.2023.1087241. eCollection 2023.
PubMed 37274268Sac G, Ozulug M, Geiger MF, Freyhof J. Pseudophoxinus cilicicus, a new spring minnow from southern Anatolia (Teleostei: Leuciscidae). Zootaxa. 2019 Sep 16;4671(1):zootaxa.4671.1.8. doi: 10.11646/zootaxa.4671.1.8.
PubMed 31716597Aksu C, Gurkan Y. Ultrasound guided erector spinae block for postoperative analgesia in pediatric nephrectomy surgeries. J Clin Anesth. 2018 Mar;45:35-36. doi: 10.1016/j.jclinane.2017.12.021. Epub 2017 Dec 20. No abstract available.
PubMed 29274546Wu L, Zhang W, Wei Y, Zhang D. Comparison of the analgesic effects of ultrasound-guided erector spinae plane block and quadratus lumborum block: a systematic review and meta-analysis. Front Pharmacol. 2025 Aug 1;16:1640135. doi: 10.3389/fphar.2025.1640135. eCollection 2025.
PubMed 40822461Aksoy M, Aksoy AN, Yilmaz EPT, Senocak GNC, Dostbil A, Ozkan H. The effectiveness of erector spina plane, quadratus lumborum blocks, and intrathecal morphine for analgesia after cesarean: a randomized study. Rev Assoc Med Bras (1992). 2023 Nov 13;69(12):e20230867. doi: 10.1590/1806-9282.20230867. eCollection 2023.
PubMed 37971133Zhang M, Zhao S, Song S, Zhou H, Li M, Su P, Xu G. Comparative analgesic efficacy of erector spinae plane block versus quadratus lumborum block in laparoscopic renal cancer surgery: a double-blind randomized trial. Transl Androl Urol. 2025 Jul 30;14(7):2029-2042. doi: 10.21037/tau-2025-71. Epub 2025 Jul 28.
PubMed 40800097An Y, Li L, Li Z, Lan F, Wang T, Ou T, Liang C, Wang P, Jia X, Song H, Cui K, Luo H, Zhao L. Anterior quadratus lumborum block is superior to erector spinae plane block for analgesia after renal transplantation: a randomized controlled trial. BMC Anesthesiol. 2025 Jul 10;25(1):343. doi: 10.1186/s12871-025-03209-5.
PubMed 40640721Wu H, Huang J. Quadratus lumborum block versus caudal block in paediatric surgeries: a protocol for systematic review and meta-analysis. BMJ Open. 2025 May 28;15(5):e100085. doi: 10.1136/bmjopen-2025-100085.
PubMed 40441771Kayumova PM, Giyasov SI, Krasnenkova MB, Musabaev AN. Erector Spinae Plane block: evaluation of its efficacy as a component of multimodal anaesthesia in open kidney surgery. Urology Herald. 2024;12(1):36-44.
Kambey BI, Ramlan AAW, Rahendra R, Selene NB. Ultrasonogram-Guided Continuous Quadratus Lumborum Block as Pain Management in Pediatric Kidney Transplant Recipients: A Case Series. Exp Clin Transplant. 2025 Jan;23(1):72-77. doi: 10.6002/ect.2024.0205.
PubMed 39918196Capuano P, Burgio G, Abbate S, Ranucci G, Bici K, Cintorino D, Arcadipane A, Martucci G. Continuous Erector Spinae Plane Block for Pain Management in a Pediatric Kidney Transplant Recipient: A Case Report and Review of the Current Literature. J Clin Med. 2024 Feb 17;13(4):1128. doi: 10.3390/jcm13041128.
PubMed 38398441
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Quadratus Lumborum Block for Post Operative Analgesia in Pediatric Kidney Surgery
- ClinicalTrials.gov ID
- NCT07346417
- Acronym / sponsor ID
- ESP-QLB-Peds / Pediatric-Block-Study-2025
- Conditions
- Kidney Diseases
- Keywords
- Pediatric- kidney-surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 16 Jan 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.
To compare the efficacy and safety of ultrasound-guided ESPB versus QLB for post-operative analgesia in children undergoing kidney surgery.
Detailed description
The management of postoperative pain in pediatric kidney surgery is a critical component of enhanced recovery and improved patient outcomes. Effective analgesia minimizes opioid consumption and their associated side effects, facilitating early mobilization and discharge. Regional anesthesia techniques have gained prominence as opioid-sparing modalities in pediatric patients, with the erector spinae plane block (ESPB) and quadratus lumborum block (QLB) increasingly used in abdominal and renal surgeries.
The erector spinae plane block is a fascial plane block targeting the dorsal rami of spinal nerves, providing extensive analgesia for thoracic and abdominal procedures. It is considered relatively easy and safe to perform under ultrasound guidance and has been associated with effective postoperative analgesia and reduced opioid requirements in pediatric renal surgery. Additional advantages include shorter block performance time and a lower incidence of postoperative nausea and vomiting compared with other regional techniques.
The quadratus lumborum block involves local anesthetic deposition near the quadratus lumborum muscle and can be performed using different approaches, such as anterior and transmuscular techniques. These approaches provide both somatic and visceral analgesia for lower abdominal and renal surgeries. Continuous quadratus lumborum block has demonstrated effective postoperative pain control, reduced need for rescue analgesia, and minimal adverse events in pediatric renal procedures. It is also recognized for its favorable safety profile and its contribution to improved quality of recovery.
Although both ESPB and QLB are effective regional techniques for pediatric postoperative analgesia, studies comparing their efficacy have reported variable results. Some investigations have shown comparable pain scores and opioid consumption between the two blocks, while others suggest potential advantages of one technique over the other in terms of analgesic duration, side-effect profile, or patient satisfaction.
Pain assessment in pediatric patients remains challenging because of differences in age, cognitive development, and communication abilities. This necessitates the use of objective pain scoring systems and careful perioperative analgesic planning. Consequently, evaluating and comparing the analgesic efficacy and safety of these two regional blocks in pediatric kidney surgery is of particular clinical importance.
The rationale of this study is to provide direct comparative evidence on the effectiveness and safety of ultrasound-guided ESPB versus QLB for postoperative analgesia in pediatric kidney surgery. Clarifying which technique offers superior analgesic control with fewer side effects may help optimize perioperative pain management protocols and improve postoperative outcomes. This study aims to assess postoperative pain scores, opioid consumption, block-related complications, and recovery quality in order to guide anesthetic decision-making in pediatric renal surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block | Experimental | Procedure: Quadratus lumborum block teqnique, Procedure: Erector spinae plane block TechniqueUltrasound-guided erector spinae plane block performed at the thoracic level using a multi-shot technique after completion of surgery and before extubation for pediatric kidney surgery to provide postoperative analgesia. |
| Quadratus lumborum block | Active comparator | Procedure: Quadratus lumborum block teqnique, Procedure: Erector spinae plane block TechniqueUltrasound-guided quadratus lumborum block performed using a multi-shot technique, after completion of surgery and before extubation of anesthesia for pediatric kidney surgery to provide postoperative analgesia. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children of both sexes, aged 2-12 years, with ASA physical status I-II scheduled for elective unilateral kidney surgery will be eligible.
Key exclusion criteria (3 listed)
- Infection at the site of needle insertion
- Allergy to local anesthetics
- Parental refusal of consent
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 |
|---|---|---|
| Quadratus lumborum block teqniqueAll blocks were performed under ultrasound guidance. A high-frequency linear probe was positioned in the mid-axillary line cranial to the iliac crest to identify the abdominal wall muscles (external oblique, internal oblique, and transversus abdominis). The probe was then moved dorsally until the transversus abdominis muscle became aponeurotic, which was followed medially to visualize the quadratus lumborum (QL) muscle at its attachment to the L4 transverse process adjacent to the psoas muscle. Using an in-plane anterior-to-posterior approach, the block needle was advanced toward the anterior border of the QL muscle. After confirming the needle tip position with a 1 ml saline test injection, 0.5 ml/kg of 0.25% bupivacaine was administered. Bilateral injections were performed for midline incisions, while unilateral injections were used for paramedian incisions. | Procedure or surgery | Erector spinae plane block, Quadratus lumborum block |
| Erector spinae plane block TechniqueUltrasound-guided erector spinae plane block performed at the thoracic level using a single-shot technique in pediatric patients undergoing kidney surgery to provide postoperative analgesia. Local anesthetic is injected deep to the erector spinae muscle over the transverse process with expected craniocaudal spread. | Procedure or surgery | Erector spinae plane block, Quadratus lumborum block |
Primary outcome
Time to first rescue analgesia
Time frame: 24 hours
measured from extubation until the first request/administration of analgesia, in hours
6 secondary outcomes
Total analgesic consumption
Time frame: 24 hours
Postoperative pain score
Time frame: 24 hours
Incidence of postoperative nausea and vomiting
Time frame: 24 hours
Block-related complications
Time frame: 24 hours
Postoperative hemodynamic stability
Time frame: 24 hours
Parent satisfaction
Time frame: 24 hours
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 16 Jan 2026.
- Results publication: PubMed 37274268Wu X, He H, Zhao L, Zeng Z, Yuan J. Case Report: Gastric cancer with chondromyxoid matrix similar matrix-producing metaplastic breast carcinoma: report of an undescribed entity. Front Oncol. 2023 May 19;13:1087241. doi: 10.3389/fonc.2023.1087241. eCollection 2023.
- Results publication: PubMed 31716597Sac G, Ozulug M, Geiger MF, Freyhof J. Pseudophoxinus cilicicus, a new spring minnow from southern Anatolia (Teleostei: Leuciscidae). Zootaxa. 2019 Sep 16;4671(1):zootaxa.4671.1.8. doi: 10.11646/zootaxa.4671.1.8.
- Results publication: PubMed 29274546Aksu C, Gurkan Y. Ultrasound guided erector spinae block for postoperative analgesia in pediatric nephrectomy surgeries. J Clin Anesth. 2018 Mar;45:35-36. doi: 10.1016/j.jclinane.2017.12.021. Epub 2017 Dec 20. No abstract available.
- Results publication: PubMed 40822461Wu L, Zhang W, Wei Y, Zhang D. Comparison of the analgesic effects of ultrasound-guided erector spinae plane block and quadratus lumborum block: a systematic review and meta-analysis. Front Pharmacol. 2025 Aug 1;16:1640135. doi: 10.3389/fphar.2025.1640135. eCollection 2025.
- Results publication: PubMed 37971133Aksoy M, Aksoy AN, Yilmaz EPT, Senocak GNC, Dostbil A, Ozkan H. The effectiveness of erector spina plane, quadratus lumborum blocks, and intrathecal morphine for analgesia after cesarean: a randomized study. Rev Assoc Med Bras (1992). 2023 Nov 13;69(12):e20230867. doi: 10.1590/1806-9282.20230867. eCollection 2023.
- Results publication: PubMed 40800097Zhang M, Zhao S, Song S, Zhou H, Li M, Su P, Xu G. Comparative analgesic efficacy of erector spinae plane block versus quadratus lumborum block in laparoscopic renal cancer surgery: a double-blind randomized trial. Transl Androl Urol. 2025 Jul 30;14(7):2029-2042. doi: 10.21037/tau-2025-71. Epub 2025 Jul 28.
- Results publication: PubMed 40640721An Y, Li L, Li Z, Lan F, Wang T, Ou T, Liang C, Wang P, Jia X, Song H, Cui K, Luo H, Zhao L. Anterior quadratus lumborum block is superior to erector spinae plane block for analgesia after renal transplantation: a randomized controlled trial. BMC Anesthesiol. 2025 Jul 10;25(1):343. doi: 10.1186/s12871-025-03209-5.
- Results publication: PubMed 40441771Wu H, Huang J. Quadratus lumborum block versus caudal block in paediatric surgeries: a protocol for systematic review and meta-analysis. BMJ Open. 2025 May 28;15(5):e100085. doi: 10.1136/bmjopen-2025-100085.
- Results publicationKayumova PM, Giyasov SI, Krasnenkova MB, Musabaev AN. Erector Spinae Plane block: evaluation of its efficacy as a component of multimodal anaesthesia in open kidney surgery. Urology Herald. 2024;12(1):36-44.
- Results publication: PubMed 39918196Kambey BI, Ramlan AAW, Rahendra R, Selene NB. Ultrasonogram-Guided Continuous Quadratus Lumborum Block as Pain Management in Pediatric Kidney Transplant Recipients: A Case Series. Exp Clin Transplant. 2025 Jan;23(1):72-77. doi: 10.6002/ect.2024.0205.
- Results publication: PubMed 38398441Capuano P, Burgio G, Abbate S, Ranucci G, Bici K, Cintorino D, Arcadipane A, Martucci G. Continuous Erector Spinae Plane Block for Pain Management in a Pediatric Kidney Transplant Recipient: A Case Report and Review of the Current Literature. J Clin Med. 2024 Feb 17;13(4):1128. doi: 10.3390/jcm13041128.
Related trials for Kidney Diseases
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
RecruitingObservational study
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Chronic Kidney Disease
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
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 Quadratus lumborum block teqnique and Erector spinae plane block Technique in people with Kidney Diseases, 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 1 inclusion and 3 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 16 Jan 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 rescue analgesia (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 NCT07346417, which also lists 11 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 16 Jan 2026.