Bilateral Inguinal Hernia RepairNCT07853586
Ultrasound-guided Quadratus Lumborum Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Children Undergoing Elective Open Lower Abdominal Surgeries
A study testing ultrasound guided anterior oudratus lumborum block and Ultrasound guided erector spinae plane block in people with Bilateral Inguinal Hernia Repair and Open Upper Abdominal Surgeries, run by Menoufia University at 1 site in Egypt.
Trial summary
To compare the postoperative analgesic efficacy of ultrasound-guided Quadratus Lumborum Block (anterior approach) versus Erector Spinae Plane Block (T10-T12 level), both performed bilaterally with 0.25% bupivacaine (0.5 mL/kg per side), in the first 24 hours postoperatively in children undergoing elective open lower… Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Bilateral Inguinal Hernia Repair, Open Upper Abdominal Surgeries
- What is being tested?
- ultrasound guided anterior oudratus lumborum block and Ultrasound guided erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Jul 2027
- Phase
- Interventional
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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 2 to 7 years.
- ASA Physical Status Classification I or II .
- Scheduled for elective minor open lower abdominal surgery (bilateral inguinal hernia repair, orchiopexy, circumcision, bilateral hydrocele repair), pyeloplasty and ureteric reimplantation.
- Weight between 10 and 25 kg.
Who cannot join
- Known allergy or hypersensitivity to local anesthetics (amide class).
- Contraindications to regional anesthesia: coagulopathy (INR > 1.5, platelets < 80,000/mm³), local infection at the injection site, or raised intracranial pressure.
- Pre-existing neurological, neuromuscular, or spinal disorders.
- Significant hepatic dysfunction (Child-Pugh Class B or C) or severe renal impairment (eGFR < 30 mL/min/1.73 m²).
- Previous abdominal or retroperitoneal surgery which likely to distort fascial planes at the injection site.
- Emergency or redo surgical procedures.
- Inability to assess postoperative pain due to pre-existing developmental or cognitive impairment preventing validated pain scale use.
- Intraoperative conversion from open to laparoscopic approach (post-randomization exclusion criterion).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasound-guided Quadratus Lumborum Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Children Undergoing Elective Open Lower Abdominal Surgeries: a Randomized Comparative Clinical Trial
To compare the postoperative analgesic efficacy of ultrasound-guided Quadratus Lumborum Block (anterior approach) versus Erector Spinae Plane Block (T10-T12 level), both performed bilaterally with 0.25% bupivacaine (0.5 mL/kg per side), in the first 24 hours postoperatively in children undergoing elective open lower abdominal surgery under general anesthesia.
- Being tested
- ultrasound guided anterior oudratus lumborum block, Ultrasound guided erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided anterior oudratus lumborum blockProcedure or surgery
A high-frequency linear probe will be used to visualize the structures and a 22G, 80-mm echogenic needle will be inserted to deposit the drug. The probe will be placed above the iliac crest, and Petit's triangle will be identified. The three abdominal muscles (i.e., the external oblique, internal oblique, and transversus abdominus muscles) will be identified and will follow posteriorly until the layers of the Thoracolumbar Fascia (TLF) appeared as a bright hyper-echogenic line. The needle will be inserted in-plane along the posterior edge of the probe in anteromedial direction targeting the plane between the quadratus lumborum and psoas major muscle. After confirming the correct needle tip position and negative aspiration for blood, 0.5 mL/kg of 0.25% bupivacaine will be injected incrementally under real-time ultrasound guidance. The procedure will be repeated on the contralateral side.
Ultrasound guided erector spinae plane blockProcedure or surgery
The patient will be placed in the prone or lateral decubitus position. The ultrasound probe will be positioned para-sagittally approximately 2-3 cm lateral to the midline at the T10-T12 vertebral level. The T11 transverse process will be identified deep to the erector spinae muscle complex.
Using an in-plane caudal-to-cranial approach, a 22-gauge echogenic needle will be advanced until the tip contacts the transverse process. Following confirmation of correct plane by injection of 0.5-1 mL saline creating hydrodissection between the erector spinae and transverse process, 0.5 mL/kg of 0.25% bupivacaine will be injected incrementally. The procedure will be repeated contralaterally ].
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided anterior quadratus lumborum block | Active comparator | Not described Receives: Procedure: ultrasound guided anterior oudratus lumborum block |
| ultrasound guided erector spinae block | Active comparator | Not described Receives: Procedure: Ultrasound guided erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of first analgesic request
Measured: in the first 24 hours
Secondary outcomes (2)
total opioid (fentanyl equivalent) consumption /ug
Measured: the first 24 hours postoperatively
postoperative pain intensity using the FLACC Scale (Face, Legs, Activity, Cry, Consolability) this scale range from 0to10 where 0 means no pain while 10 means worest untolerable pain
Interpreting the Score
- 0: Relaxed and comfortable
- 1-3: Mild discomfort
- 4-6: Moderate pain
- 7-10: Severe pain or discomfort
Measured: 0, 30 minutes, 1, 2, 4, 6, 12, and 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Inguinal Hernia RepairStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevine Mostafa Soliman, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853586
- Sponsor's protocol ID
- 7/2026ANET47
- Status last verified
- Jul 2026
- First submitted
- 26 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided