Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
NCT07916233, Not applicable, Not yet recruiting, Beni-Suef University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair | ClinicalTrials.gov |
| NCT number | NCT07916233 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beni-Suef University | ClinicalTrials.gov |
| Conditions | Inguinal Hernia, Postoperative Pain | ClinicalTrials.gov |
| Interventions | Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB), Ultrasound-guided Transversus Abdominis Plane (TAP) Block | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Time to First Postoperative Rescue Analgesia Request | 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. | ClinicalTrials.gov |
| Secondary | Postoperative FLACC Pain Scores | At PACU arrival (0 hours), 1, 2, 4, and 6 hours postoperatively | 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. | ClinicalTrials.gov |
| Secondary | Area Under the Curve (AUC) of Postoperative FLACC Pain Scores | From PACU arrival (0 hours) through 6 hours postoperatively | 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). | ClinicalTrials.gov |
| Secondary | Percentage of Participants Requiring Postoperative Rescue Opioids | Up to 24 hours postoperatively | Measured as the proportion of participants in each group who receive at least one dose of rescue opioid analgesia within the observation window. | ClinicalTrials.gov |
| Secondary | Total Cumulative 24-Hour Postoperative Opioid Consumption | 24 hours postoperatively | Cumulative intravenous and oral rescue opioid consumption converted to standard Morphine Milligram Equivalents per kilogram of body weight (MME/kg). | ClinicalTrials.gov |
| Secondary | Total Intraoperative Fentanyl Consumption | Intraoperatively (from surgical incision to skin closure) | 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). | ClinicalTrials.gov |
| Secondary | Incidence of Postoperative Nausea and Vomiting (PONV) | Up to 24 hours postoperatively | Percentage of participants experiencing at least one episode of postoperative nausea or vomiting requiring antiemetic treatment. | ClinicalTrials.gov |
| Secondary | Time to First Mobilization | Up to 24 hours postoperatively | Measured in hours from the end of anesthesia to first unassisted/age-appropriate ambulation | ClinicalTrials.gov |
| Secondary | Parental Satisfaction Score at 24 Hours | 24 hours postoperatively | Assessed via structured telephone follow-up using a 5-point Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied; higher scores indicate greater satisfaction). | ClinicalTrials.gov |
| Secondary | Incidence of Block-Related and Anesthetic Adverse Events | Up to 24 hours postoperatively | 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. | ClinicalTrials.gov |
| Secondary | Incidence of Postoperative Lower Extremity Motor Blockade | At PACU arrival, 2 hours postoperatively, and prior to discharge (up to 24 hours) | 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. | ClinicalTrials.gov |
| Secondary | Time to Hospital Discharge Readiness | Up to 24 hours postoperatively | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)