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

NCT ID: NCT05737394

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

Although pain in laparoscopic procedures has been demonstrated to be inferior to that of laparotomic ones, it is still produced because of rapid distension of peritoneum, visceral manipulation, irritation and traction of vessels and phrenic nerves, presence of residual gas and inflammatory mediators.

Analgesia can be achieved with multimodal techniques, which include oral or intravenous drugs as well as loco-regional anesthesia techniques.

The abdominal wall has three muscle layers: external and internal obliques, and transversus abdominis. They are innervated by mixed somatic nerves that course between the transversus abdominis and the internal oblique muscles.

Transversus Abdominis Plane Block is a regional analgesia technique which consists of injecting local anaesthetics between the transversus abdominis and internal oblique muscles, providing analgesia to the parietal peritoneum, skin and muscles of the anterior abdominal wall. It can provide benefit in both open and laparoscopic procedures and it is a safe technique, with a very low reported rate of complications.

Three major techniques are used to perform the Transversus Abdominis Plane (TAP) block-a landmark-based, an ultrasound-guided, and a surgical- placed TAP block.

Although the landmark technique is easy to perform, it might be complicated by inadvertent intraperitoneal organ damage.

Surgically administered Transversus Abdominis Plane (TAP) blocks have been performed by surgeons intraoperatively using the transperitoneal approach, accessing the Transversus Abdominis Plane (TAP) from the inside of the abdominal wall. Direct visualization of the needle and local anaesthetic spread may help to increase the accuracy as well as eliminating the risk of intraabdominal organ injury and is technically less difficult. It is however necessarily placed after incision and pneumoperitoneum establishment.

Ultrasound-guided Transversus Abdominis Plane (TAP) block on the other side can be performed prior to incision and pneumoperitoneum, thus avoiding nociception from the very beginning.

Aim of the present prospective, randomised, single center controlled study is to compare postoperative analgesic efficacy of laparo-assisted vs ultrasound-guided Transversus Abdominis Plane (TAP) block in pediatric laparoscopic procedures. Primary outcome will be the comparison of pain scores between groups upon arrival to Post-Anesthesia Care Unit (PACU).

Secondary outcomes are:

• pain scores at 1 and 6 hours after surgery
• general anesthesia requirements, as defined by Minimum Alveolar Concentration-hour (MAC_hour)
• intraoperative opiod consumption
• complication rates
• time to block completion

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Laparoscopy-guided TAP Block

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

Group Type: EXPERIMENTAL

Laparoscopic-guided TAP Block

Intervention Type: PROCEDURE

Laparoscopically-assisted placement of block

Ultrasound-guided TAP Block

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

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided TAP Block

Intervention Type: PROCEDURE

Ultrasound-assisted placement of block

Interventions

Laparoscopic-guided TAP Block

Laparoscopically-assisted placement of block

Intervention Type: PROCEDURE

Ultrasound-guided TAP Block

Ultrasound-assisted placement of block

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vittore Buzzi Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anna Camporesi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vittore Buzzi Children's Hospital

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Anna Camporesi, M.D.

Role: CONTACT

anna.camporesi@gmail.com

+393355793744

Facility Contacts

Anna Camporesi, MD

Role: primary

anna.camporesi@asst-fbf-sacco.it

+393355793744

Ugo Maria Pierucci, MD

Role: backup

ugomaria.pierucci@asst-fbf-sacco.it

Other Identifiers

2022/ST/264

Identifier Type: -

Identifier Source: org_study_id