Lap-guided vs Us-guided TAP Block in Pediatric Laparoscopy

NCT05737394 | Recruiting

• 1 other identifier: 2022/ST/264
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Transversus Abdominis Plane (TAP) block is commonly used to control pain in laparoscopic procedures. It is usually administered with ultrasound guide but it can be also administered with laparoscopic assistance under direct visualization. Aim of the present study is determining if the lap-assisted TAP is superior to the us-guided TAP Block in pain control in the immediate postoperative phase as well at 1 and 6 hours post surgery.

Conditions

Postoperative Pain

Keywords

tap block; laparoscopy; pediatric surgery

Outcome Measures

Primary Outcomes (1)

• Pain scores in PACU

  Pain will be measured with FLACC scale (0-10 points; 0 no pain, 10 maximal pain) by operators blinded to the TAP technique

  Post-Anesthesia Care Unit - immediately after end of surgery

Secondary Outcomes (4)

• Pain scores at 1 and 6 hours post-op

  first 6 hours post - op

• Intraoperative opioids requirements

  Intraoperative

• General anesthetic requirements

  Intraoperative

• Time to Block completion

  Intraoperative

Study Arms (2)

Laparoscopy-guided TAP Block

EXPERIMENTAL

Patients will receive surgically-placed TAP block right after pneumoperitoneum induction and before Trocar insertion with levobupivacaine 0.25%, 0.5 ml/kg.

Procedure: Laparoscopic-guided TAP Block

Ultrasound-guided TAP Block

ACTIVE COMPARATOR

Patients will receive ultrasound-guided TAP block performed after anesthetic induction and before surgical incision with levobupivacaine 0.25%, 0.5 ml/kg.

Procedure: Ultrasound-guided TAP Block

Interventions

Laparoscopic-guided TAP Block PROCEDURE

Laparoscopically-assisted placement of block

Laparoscopy-guided TAP Block

Ultrasound-guided TAP Block PROCEDURE

Ultrasound-assisted placement of block

Ultrasound-guided TAP Block

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age\<= 18 yrs
• Elective or urgent laparoscopic surgical procedures including hernia repair, appendectomy, cholecystectomy, piloromyotomy, Nissen fundoplication, varicocelectomy
• ASA Status I and II

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vittore Buzzi Children's Hospital: lead

Study Sites (1)

Vittore Buzzi Children's Hospital

Milan, 20154, Italy

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Anna Camporesi, M.D.

CONTACT

+393355793744; anna.camporesi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: June 1, 2024
• Primary Completion: October 28, 2024
• Study Completion: December 31, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)