Inguinal HerniaNCT07916233
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
A study testing Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB) and Ultrasound-guided Transversus Abdominis Plane (TAP) Block in people with Inguinal Hernia and Postoperative Pain, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This study evaluates two ultrasound-guided nerve block techniques-Erector Spinae Plane Block (ESPB) and Transversus Abdominis Plane (TAP) block-for pain relief in children undergoing elective open inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Inguinal Hernia, Postoperative Pain
- What is being tested?
- Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB) and Ultrasound-guided Transversus Abdominis Plane (TAP) Block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to May 2027
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 to 8 years at the time of enrollment.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective unilateral open inguinal hernia repair as day-case or short-stay surgery.
- Body weight between 10 kg and 35 kg (to ensure local anesthetic dosing remains within predefined safe exposure limits).
- Written informed consent provided by parents or legal guardians, and age-appropriate assent from children where developmentally feasible.
Who cannot join
- Refusal of trial participation by parents or legal guardians.
- Known allergy, hypersensitivity, or contraindication to amide local anesthetics, paracetamol, or ibuprofen.
- Coagulopathy, bleeding disorder, or current anticoagulant/antiplatelet therapy.
- Active localized infection at or near either planned injection site (paraspinal or lateral abdominal wall).
- Pre-existing neurological, neuromuscular, or spinal disease affecting the lower limbs or trunk.
- Significant hepatic, renal, or cardiac dysfunction.
Show all 9Show fewer
- Severe cerebral palsy, developmental delay, or neurobehavioral disorders resulting in abnormal baseline tone or movement that would render behavioral pain scoring (FLACC) unreliable.
- Bilateral inguinal hernia repair (due to bilateral block considerations).
- Previous participation in this clinical trial.
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 Lumbar Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children Undergoing Open Inguinal Hernia Repair: A Randomized Double-Blind Controlled Trial
This study evaluates two ultrasound-guided nerve block techniques-Erector Spinae Plane Block (ESPB) and Transversus Abdominis Plane (TAP) block-for pain relief in children undergoing elective open inguinal hernia repair.
Children aged 2 to 8 years scheduled for unilateral open inguinal hernia surgery under general anesthesia will be randomly assigned to receive either a lumbar ESP block or a TAP block before surgery begins. Both groups will receive standardized pain management with non-opioid pain relievers (paracetamol and ibuprofen).
The main goal of the study is to compare how long each nerve block provides effective pain relief before the child requires additional pain medication (rescue opioid) within the first 24 hours after surgery. The study will also assess overall pain scores, total opioid consumption, postoperative recovery, and safety.
Read the detailed description
Effective postoperative analgesia is essential in pediatric open inguinal hernia repair to attenuate the surgical stress response, facilitate early ambulation, and enable same-day discharge. While caudal epidural block has traditionally served as the standard regional technique in pediatric lower abdominal surgery, concerns regarding motor block, urinary retention, and rare neuraxial complications have driven interest toward peripheral ultrasound-guided fascial plane blocks.
Ultrasound-guided Transversus Abdominis Plane (TAP) block provides somatic analgesia to the anterolateral abdominal wall by targeting the anterior rami of lower thoracolumbar spinal nerves (T10-L1). Recent meta-analyses demonstrate that TAP block prolongs analgesia duration and reduces rescue opioid requirements compared to caudal blockade.
Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB) is an interfascial plane technique where local anesthetic deposited deep to the erector spinae muscle at the L1 transverse process produces craniocaudal spread, blocking dorsal and ventral rami. Recent trials suggest lumbar ESPB provides effective somatic analgesia, but the degree of visceral inguinal coverage via genitofemoral and ilioinguinal pathways remains debated.
Direct, prospective head-to-head comparisons between ultrasound-guided lumbar ESPB and TAP block in pediatric open inguinal hernia repair remain limited-particularly studies utilizing a double-blind methodology, standardized multimodal analgesia, and identical local anesthetic dosing.
This prospective, randomized, double-blind controlled trial aims to compare the duration and quality of postoperative analgesia provided by ultrasound-guided lumbar ESPB versus TAP block using bupivacaine 0.25% (0.5 mL/kg, maximum 20 mL) in children aged 2-8 years undergoing elective unilateral open inguinal hernia repair under general anesthesia. The primary hypothesis is that lumbar ESPB is non-inferior to TAP block with respect to time to first rescue analgesia within 24 hours postoperatively.
- Conditions
- Inguinal Hernia, Postoperative Pain
- Being tested
- Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB), Ultrasound-guided Transversus Abdominis Plane (TAP) Block
- Keywords
- Erector Spinae Plane Block, Transversus Abdominis Plane Block, Regional Anesthesia, Pediatric Anesthesia, Ultrasonography, Interventional, Bupivacaine, Herniorrhaphy, Acute Pain Management
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB)Procedure or surgery
Also called L-ESPB
Single-shot ultrasound-guided lumbar ESP block performed at the L1 transverse process level using bupivacaine 0.25% at 0.5 mL/kg (maximum 20 mL, total dose 1.25 mg/kg) deposited deep to the erector spinae muscle. Administered after general anesthesia induction and before surgical incision. Standardized multimodal background analgesia (IV paracetamol 15 mg/kg q6h ± oral/IV ibuprofen 10 mg/kg q8h) is co-administered postoperatively.
Ultrasound-guided Transversus Abdominis Plane (TAP) BlockProcedure or surgery
Also called TAP block
Single-shot ultrasound-guided TAP block performed between the internal oblique and transversus abdominis muscles at the mid-axillary line using bupivacaine 0.25% at 0.5 mL/kg (maximum 20 mL, total dose 1.25 mg/kg). Administered after general anesthesia induction and before surgical incision. Standardized multimodal background analgesia (IV paracetamol 15 mg/kg q6h ± oral/IV ibuprofen 10 mg/kg q8h) is co-administered postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Group E: Lumbar Erector Spinae Plane Block (ESPB) | Experimental | Children in Group E receive an ultrasound-guided lumbar erector spinae plane block (ESPB) performed in the lateral decubitus position prior to surgical incision following general anesthesia induction. A 22-gauge 50-mm echogenic needle is advanced in-plane to contact the L1 transverse process deep to the erector spinae muscle. After negative aspiration and hydrodissection verification with 1-2 mL saline, bupivacaine 0.25% at a volume of 0.5 mL/kg (maximum 20 mL; total dose 1.25 mg/kg) is injected incrementally. Identical sterile dressings are applied over both the paraspinal and abdominal block sites to maintain blinding. Receives: Procedure: Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB) |
| Group T: Transversus Abdominis Plane (TAP) Block | Active comparator | Children in Group T receive an ultrasound-guided transversus abdominis plane (TAP) block performed in the supine position prior to surgical incision following general anesthesia induction. A 22-gauge 50-mm echogenic needle is advanced in-plane into the fascial plane between the internal oblique and transversus abdominis muscles at the mid-axillary line. After negative aspiration and hydrodissection verification with 1-2 mL saline, bupivacaine 0.25% at a volume of 0.5 mL/kg (maximum 20 mL; total dose 1.25 mg/kg) is injected incrementally. Identical sterile dressings are applied over both the paraspinal and abdominal block sites to maintain blinding. Receives: Procedure: Ultrasound-guided Transversus Abdominis Plane (TAP) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Postoperative Rescue Analgesia Request
Measured as the duration (in hours) from the end of general anesthesia (tracheal extubation) until the first administration of rescue opioid. Rescue analgesia is triggered when a trained blinded observer records a Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain score greater than 3 on two consecutive assessments separated by 15 minutes.
Measured: Up to 24 hours postoperatively
Secondary outcomes (11)
Postoperative FLACC Pain Scores
Assessed using the validated Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale (total score range: 0 to 10; higher scores indicate greater pain intensity). Recorded at discrete in-hospital time points.
Measured: At PACU arrival (0 hours), 1, 2, 4, and 6 hours postoperatively
Area Under the Curve (AUC) of Postoperative FLACC Pain Scores
Calculated using the trapezoidal rule from serial FLACC pain scores (range 0-10) recorded over the first 6 post-anesthesia hours to derive cumulative pain exposure (score·hours).
Measured: From PACU arrival (0 hours) through 6 hours postoperatively
Percentage of Participants Requiring Postoperative Rescue Opioids
Measured as the proportion of participants in each group who receive at least one dose of rescue opioid analgesia within the observation window.
Measured: Up to 24 hours postoperatively
Total Cumulative 24-Hour Postoperative Opioid Consumption
Cumulative intravenous and oral rescue opioid consumption converted to standard Morphine Milligram Equivalents per kilogram of body weight (MME/kg).
Measured: 24 hours postoperatively
Total Intraoperative Fentanyl Consumption
Total dose of intravenous fentanyl administered intraoperatively for rescue hemodynamic responses (heart rate or mean arterial pressure > 20% above baseline), expressed in micrograms per kilogram (µg/kg).
Measured: Intraoperatively (from surgical incision to skin closure)
Incidence of Postoperative Nausea and Vomiting (PONV)
Percentage of participants experiencing at least one episode of postoperative nausea or vomiting requiring antiemetic treatment.
Measured: Up to 24 hours postoperatively
Time to First Mobilization
Measured in hours from the end of anesthesia to first unassisted/age-appropriate ambulation
Measured: Up to 24 hours postoperatively
Parental Satisfaction Score at 24 Hours
Assessed via structured telephone follow-up using a 5-point Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied; higher scores indicate greater satisfaction).
Measured: 24 hours postoperatively
Incidence of Block-Related and Anesthetic Adverse Events
Percentage of participants experiencing block-related or systemic complications, including local anesthetic systemic toxicity (LAST), vascular puncture, hematoma, local infection, pneumothorax, or urinary retention requiring catheterization.
Measured: Up to 24 hours postoperatively
Incidence of Postoperative Lower Extremity Motor Blockade
Assessed using a modified Bromage scale or age-appropriate motor strength score (ability to flex knees and ankles) prior to discharge to confirm complete absence of lower limb motor weakness.
Measured: At PACU arrival, 2 hours postoperatively, and prior to discharge (up to 24 hours)
Time to Hospital Discharge Readiness
Measured as the time duration (in hours) from the end of general anesthesia (extubation) until achievement of standard discharge criteria (Modified Aldrete score ≥ 9, stable vital signs for ≥ 1 hour, FLACC pain score ≤ 3 on scheduled non-opioid analgesics alone, adequate oral fluid intake without intractable nausea or vomiting, and absence of active surgical or regional block complications
Measured: Up to 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 posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerollos Moneer Neseem Mikhael, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916233
- Sponsor's protocol ID
- FMBSUREC/07062026/ Mikhael
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the trial, including baseline demographic characteristics, primary outcome measurements (time to first rescue analgesia), serial FLACC pain scores, cumulative opioid consumption, and recorded adverse events, will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children Undergoing Open Inguinal Hernia Repair: A Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07916233
- Acronym / sponsor ID
- FMBSUREC/07062026/ Mikhael
- Conditions
- Inguinal Hernia, Postoperative Pain
- Keywords
- Erector Spinae Plane Block, Transversus Abdominis Plane Block, Regional Anesthesia, Pediatric Anesthesia, Ultrasonography, Interventional, Bupivacaine, Herniorrhaphy, Acute Pain Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Nov 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.
This study evaluates two ultrasound-guided nerve block techniques-Erector Spinae Plane Block (ESPB) and Transversus Abdominis Plane (TAP) block-for pain relief in children undergoing elective open inguinal hernia repair.
Children aged 2 to 8 years scheduled for unilateral open inguinal hernia surgery under general anesthesia will be randomly assigned to receive either a lumbar ESP block or a TAP block before surgery begins. Both groups will receive standardized pain management with non-opioid pain relievers (paracetamol and ibuprofen).
The main goal of the study is to compare how long each nerve block provides effective pain relief before the child requires additional pain medication (rescue opioid) within the first 24 hours after surgery. The study will also assess overall pain scores, total opioid consumption, postoperative recovery, and safety.
Detailed description
Effective postoperative analgesia is essential in pediatric open inguinal hernia repair to attenuate the surgical stress response, facilitate early ambulation, and enable same-day discharge. While caudal epidural block has traditionally served as the standard regional technique in pediatric lower abdominal surgery, concerns regarding motor block, urinary retention, and rare neuraxial complications have driven interest toward peripheral ultrasound-guided fascial plane blocks.
Ultrasound-guided Transversus Abdominis Plane (TAP) block provides somatic analgesia to the anterolateral abdominal wall by targeting the anterior rami of lower thoracolumbar spinal nerves (T10-L1). Recent meta-analyses demonstrate that TAP block prolongs analgesia duration and reduces rescue opioid requirements compared to caudal blockade.
Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB) is an interfascial plane technique where local anesthetic deposited deep to the erector spinae muscle at the L1 transverse process produces craniocaudal spread, blocking dorsal and ventral rami. Recent trials suggest lumbar ESPB provides effective somatic analgesia, but the degree of visceral inguinal coverage via genitofemoral and ilioinguinal pathways remains debated.
Direct, prospective head-to-head comparisons between ultrasound-guided lumbar ESPB and TAP block in pediatric open inguinal hernia repair remain limited-particularly studies utilizing a double-blind methodology, standardized multimodal analgesia, and identical local anesthetic dosing.
This prospective, randomized, double-blind controlled trial aims to compare the duration and quality of postoperative analgesia provided by ultrasound-guided lumbar ESPB versus TAP block using bupivacaine 0.25% (0.5 mL/kg, maximum 20 mL) in children aged 2-8 years undergoing elective unilateral open inguinal hernia repair under general anesthesia. The primary hypothesis is that lumbar ESPB is non-inferior to TAP block with respect to time to first rescue analgesia within 24 hours postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E: Lumbar Erector Spinae Plane Block (ESPB) | Experimental | Procedure: Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB)Children in Group E receive an ultrasound-guided lumbar erector spinae plane block (ESPB) performed in the lateral decubitus position prior to surgical incision following general anesthesia induction. A 22-gauge 50-mm echogenic needle is advanced in-plane to contact the L1 transverse process deep to the erector spinae muscle. After negative aspiration and hydrodissection verification with 1-2 mL saline, bupivacaine 0.25% at a volume of 0.5 mL/kg (maximum 20 mL; total dose 1.25 mg/kg) is injected incrementally. Identical sterile dressings are applied over both the paraspinal and abdominal block sites to maintain blinding. |
| Group T: Transversus Abdominis Plane (TAP) Block | Active comparator | Procedure: Ultrasound-guided Transversus Abdominis Plane (TAP) BlockChildren in Group T receive an ultrasound-guided transversus abdominis plane (TAP) block performed in the supine position prior to surgical incision following general anesthesia induction. A 22-gauge 50-mm echogenic needle is advanced in-plane into the fascial plane between the internal oblique and transversus abdominis muscles at the mid-axillary line. After negative aspiration and hydrodissection verification with 1-2 mL saline, bupivacaine 0.25% at a volume of 0.5 mL/kg (maximum 20 mL; total dose 1.25 mg/kg) is injected incrementally. Identical sterile dressings are applied over both the paraspinal and abdominal block sites to maintain blinding. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 2 to 8 years at the time of enrollment.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective unilateral open inguinal hernia repair as day-case or short-stay surgery.
- Body weight between 10 kg and 35 kg (to ensure local anesthetic dosing remains within predefined safe exposure limits).
- Written informed consent provided by parents or legal guardians, and age-appropriate assent from children where developmentally feasible.
Key exclusion criteria (9 listed)
- Refusal of trial participation by parents or legal guardians.
- Known allergy, hypersensitivity, or contraindication to amide local anesthetics, paracetamol, or ibuprofen.
- Coagulopathy, bleeding disorder, or current anticoagulant/antiplatelet therapy.
- Active localized infection at or near either planned injection site (paraspinal or lateral abdominal wall).
- Pre-existing neurological, neuromuscular, or spinal disease affecting the lower limbs or trunk.
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 |
|---|---|---|
| Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB)Also: L-ESPBSingle-shot ultrasound-guided lumbar ESP block performed at the L1 transverse process level using bupivacaine 0.25% at 0.5 mL/kg (maximum 20 mL, total dose 1.25 mg/kg) deposited deep to the erector spinae muscle. Administered after general anesthesia induction and before surgical incision. Standardized multimodal background analgesia (IV paracetamol 15 mg/kg q6h ± oral/IV ibuprofen 10 mg/kg q8h) is co-administered postoperatively. | Procedure or surgery | Group E: Lumbar Erector Spinae Plane Block (ESPB) |
| Ultrasound-guided Transversus Abdominis Plane (TAP) BlockAlso: TAP blockSingle-shot ultrasound-guided TAP block performed between the internal oblique and transversus abdominis muscles at the mid-axillary line using bupivacaine 0.25% at 0.5 mL/kg (maximum 20 mL, total dose 1.25 mg/kg). Administered after general anesthesia induction and before surgical incision. Standardized multimodal background analgesia (IV paracetamol 15 mg/kg q6h ± oral/IV ibuprofen 10 mg/kg q8h) is co-administered postoperatively. | Procedure or surgery | Group T: Transversus Abdominis Plane (TAP) Block |
Primary outcome
Time to First Postoperative Rescue Analgesia Request
Time frame: Up to 24 hours postoperatively
Measured as the duration (in hours) from the end of general anesthesia (tracheal extubation) until the first administration of rescue opioid. Rescue analgesia is triggered when a trained blinded observer records a Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain score greater than 3 on two consecutive assessments separated by 15 minutes.
11 secondary outcomes
Postoperative FLACC Pain Scores
Time frame: At PACU arrival (0 hours), 1, 2, 4, and 6 hours postoperatively
Area Under the Curve (AUC) of Postoperative FLACC Pain Scores
Time frame: From PACU arrival (0 hours) through 6 hours postoperatively
Percentage of Participants Requiring Postoperative Rescue Opioids
Time frame: Up to 24 hours postoperatively
Total Cumulative 24-Hour Postoperative Opioid Consumption
Time frame: 24 hours postoperatively
Total Intraoperative Fentanyl Consumption
Time frame: Intraoperatively (from surgical incision to skin closure)
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: Up to 24 hours postoperatively
Time to First Mobilization
Time frame: Up to 24 hours postoperatively
Parental Satisfaction Score at 24 Hours
Time frame: 24 hours postoperatively
Incidence of Block-Related and Anesthetic Adverse Events
Time frame: Up to 24 hours postoperatively
Incidence of Postoperative Lower Extremity Motor Blockade
Time frame: At PACU arrival, 2 hours postoperatively, and prior to discharge (up to 24 hours)
Time to Hospital Discharge Readiness
Time frame: Up to 24 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 4 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the trial, including baseline demographic characteristics, primary outcome measurements (time to first rescue analgesia), serial FLACC pain scores, cumulative opioid consumption, and recorded adverse events, will be made available upon reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB) and Ultrasound-guided Transversus Abdominis Plane (TAP) Block in people with Inguinal Hernia and Postoperative Pain, run by Beni-Suef 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 5 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: opening soon, as of the sponsor's last update on 4 Nov 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.
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 Kerollos Moneer Neseem Mikhael, MD (00201288549959, Kmnmk87@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Postoperative Rescue Analgesia Request (time frame: Up to 24 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 4 Nov 2026.