Comparing two methods of pain relief in pediatric laparoscopic surgery
Laparoscopy-guided Versus Ultrasound-guided Transversus Abdominis Plane (TAP) Block in Pediatric Laparoscopy: a Randomized, Controlled Trial
This study is testing which of two ways to give a pain relief shot works better for kids after laparoscopic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | Vittore Buzzi Children's Hospital Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05737394 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of laparoscopic-guided Transversus Abdominis Plane (TAP) block versus ultrasound-guided TAP block in managing postoperative pain in children undergoing laparoscopic surgery. The research will assess pain control immediately after surgery and at 1 and 6 hours post-operation. By utilizing two different techniques for administering the TAP block, the study seeks to determine which method provides superior analgesia. The TAP block is a regional anesthesia technique that targets specific nerves to alleviate pain in the abdominal area.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 18 years or younger who are scheduled for elective or urgent laparoscopic surgeries.
Not a fit: Patients with significant comorbidities (ASA Status III-VI) or those requiring prolonged surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for pediatric patients undergoing laparoscopic procedures.
How similar studies have performed: Previous studies have shown promising results with TAP blocks in various surgical settings, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age\<= 18 yrs * Elective or urgent laparoscopic surgical procedures including hernia repair, appendectomy, cholecystectomy, piloromyotomy, Nissen fundoplication, varicocelectomy * ASA Status I and II Exclusion Criteria: * absence of parental consent * ASA Status III-VI * Presence of neurological disability affecting spontaneous mobility * Previous surgical procedures on the abdominal wall (e.g. gastroschisis repair) * Foreseen surgical duration bigger than 4 hours * Conversion to laparotomy * Use of concomitant other regional anesthesia technique (e.g. neuraxial or peripheral)
Where this trial is running
Milan
- Vittore Buzzi Children's Hospital — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Anna Camporesi, M.D.
- Email: anna.camporesi@gmail.com
- Phone: +393355793744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.