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

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Laparoscopic-guided TAP Block
Ultrasound-guided TAP Block
Sponsored by
Vittore Buzzi Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring tap block, laparoscopy, pediatric surgery

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vittore Buzzi Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopy-guided TAP Block

Ultrasound-guided TAP Block

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Intraoperative opioids requirements
Comparison of need for additional boluses of intraoperative opioids if HR raises more than 10% of baseline
General anesthetic requirements
Comparison of MAC-hour in the two groups
Time to Block completion
Comparison of time needed to place the block between two groups

Full Information

First Posted
February 9, 2023
Last Updated
February 18, 2023
Sponsor
Vittore Buzzi Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05737394
Brief Title
Lap-guided vs Us-guided TAP Block in Pediatric Laparoscopy
Official Title
Laparoscopy-guided Versus Ultrasound-guided Transversus Abdominis Plane (TAP) Block in Pediatric Laparoscopy: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vittore Buzzi Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Transversus Abdomens Plance (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 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 TAP blocks have been performed by surgeons intraoperatively using the transperitoneal approach, accessing the 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 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
tap block, laparoscopy, pediatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopy-guided TAP Block
Arm Type
Experimental
Arm Description
Patients will receive surgically-placed TAP block right after pneumoperitoneum induction and before Trocar insertion with levobupivacaine 0.25%, 0.5 ml/kg.
Arm Title
Ultrasound-guided TAP Block
Arm Type
Active Comparator
Arm Description
Patients will receive ultrasound-guided TAP block performed after anesthetic induction and before surgical incision with levobupivacaine 0.25%, 0.5 ml/kg.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic-guided TAP Block
Intervention Description
Laparoscopically-assisted placement of block
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided TAP Block
Intervention Description
Ultrasound-assisted placement of block
Primary Outcome Measure Information:
Title
Pain scores in PACU
Description
Pain will be measured with FLACC scale (0-10 points; 0 no pain, 10 maximal pain) by operators blinded to the TAP technique
Time Frame
Post-Anesthesia Care Unit - immediately after end of surgery
Secondary Outcome Measure Information:
Title
Pain scores at 1 and 6 hours post-op
Description
Comparison of pain scores measured with FLACC scale (0-10 points; 0 no pain, 10 maximal pain)by operators blinded to the TAP technique
Time Frame
first 6 hours post - op
Title
Intraoperative opioids requirements
Description
Comparison of need for additional boluses of intraoperative opioids if HR raises more than 10% of baseline
Time Frame
Intraoperative
Title
General anesthetic requirements
Description
Comparison of MAC-hour in the two groups
Time Frame
Intraoperative
Title
Time to Block completion
Description
Comparison of time needed to place the block between two groups
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Vittore Buzzi Children's Hospital
City
Milano
ZIP/Postal Code
20154
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Camporesi, MD
Email
anna.camporesi@asst-fbf-sacco.it
First Name & Middle Initial & Last Name & Degree
Ugo Maria Pierucci, MD
Email
ugomaria.pierucci@asst-fbf-sacco.it

12. IPD Sharing Statement

Plan to Share IPD
No

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

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