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

Laparoscopy-guided Versus Ultrasound-guided Transversus Abdominis Plane (TAP) Block in Pediatric Laparoscopy: a Randomized, Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Laparoscopic-guided TAP Block; Procedure: Ultrasound-guided TAP Block

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

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Camporesi, M.D.; Phone Number: +393355793744; Email: anna.camporesi@gmail.com

Study Locations

• Italy
  • Milano, Italy, 20154
    • Recruiting
    • Vittore Buzzi Children's Hospital
    • Contact: Anna Camporesi, MD; Phone Number: +393355793744; Email: anna.camporesi@asst-fbf-sacco.it
    • Contact: Ugo Maria Pierucci, MD; Email: ugomaria.pierucci@asst-fbf-sacco.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Laparoscopic-guided TAP Block; Laparoscopically-assisted placement of block
Active Comparator: 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.	Procedure: Ultrasound-guided TAP Block; Ultrasound-assisted placement of block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores at 1 and 6 hours post-op	Comparison of pain scores measured with FLACC scale (0-10 points; 0 no pain, 10 maximal pain)by operators blinded to the TAP technique	first 6 hours post - op
Intraoperative opioids requirements	Comparison of need for additional boluses of intraoperative opioids if HR raises more than 10% of baseline	Intraoperative
General anesthetic requirements	Comparison of MAC-hour in the two groups	Intraoperative
Time to Block completion	Comparison of time needed to place the block between two groups	Intraoperative

Collaborators and Investigators

• Sponsor: Vittore Buzzi Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 18, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: laparoscopy; pediatric surgery; tap block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2022/ST/264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No