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A Study to Compare Laparoscopic to Echographic Assisted Transversus Abdominis Plane Block in Laparoscopic Colectomy

Primary Purpose

Laparoscopic Colectomy, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
laparoscopic-assisted Transversus Abdominis Plane (TAP) block
ultrasound-assisted Transversus Abdominis Plane (TAP) block
Ropivacaine
Sponsored by
Davide La Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Colectomy focused on measuring Transversus Abdominis Plane (TAP) Block, Local Anesthetic Infiltrations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients candidates to laparoscopic colorectal surgery
  • Signed informed consent

Exclusion Criteria:

  • Age < 18 years old
  • Pregnancy
  • Allergy to local anaesthetics
  • Spinal or epidural analgesia
  • Acute inflammatory abdominal pathologies
  • Chronic pain syndrome
  • Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDS)

Sites / Locations

  • Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale
  • Ospedale Regionale di Lugano, Civico e Italiano - Ente Ospedaliero Cantonale

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic Transversus Abdominis Plane (L-TAP) group

Ultrasound Transversus Abdominis Plane (U-TAP) group

Arm Description

Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under laparoscopic control

Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under ultrasound control

Outcomes

Primary Outcome Measures

Opioids consumption
Opioid consumption measured in morphine milligram equivalents (MME) per day

Secondary Outcome Measures

Opioid consumption within the first 48 hours after the operation
Opioid consumption measured in morphine milligram equivalents (MME) per day
postoperative pain
Postoperative pain on the visual analogue scale (VAS) at 3, 6, 12, 24 hours. This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.
length of hospital stay
number of days the participant is being hospitalized
Time required to perform the (Transversus Abdominis Plane) TAP block

Full Information

First Posted
September 18, 2020
Last Updated
July 13, 2022
Sponsor
Davide La Regina
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1. Study Identification

Unique Protocol Identification Number
NCT04575233
Brief Title
A Study to Compare Laparoscopic to Echographic Assisted Transversus Abdominis Plane Block in Laparoscopic Colectomy
Official Title
Laparoscopic- Vs Ultrasound-guided Transversus Abdominis Plane Block in Laparoscopic Colectomy: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
January 11, 2022 (Actual)
Study Completion Date
January 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Davide La Regina

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
The purpose of this study is to compare the postoperative pain, the time needed and other clinical outcomes in patients who, during laparoscopic colectomy, will be injected with a local anesthetic (Ropivacaine) through an ultrasound guided technique performed by the anaesthesiologist or throught a laparoscopic assisted technique performed by the surgeon

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Colectomy, Pain, Postoperative
Keywords
Transversus Abdominis Plane (TAP) Block, Local Anesthetic Infiltrations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic Transversus Abdominis Plane (L-TAP) group
Arm Type
Experimental
Arm Description
Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under laparoscopic control
Arm Title
Ultrasound Transversus Abdominis Plane (U-TAP) group
Arm Type
Active Comparator
Arm Description
Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under ultrasound control
Intervention Type
Procedure
Intervention Name(s)
laparoscopic-assisted Transversus Abdominis Plane (TAP) block
Intervention Description
The anterior axillary line is used as landmarks. After insertion of the optic trocar, the peritoneum is visualized. A 14 Gauge needle is inserted 2 cm cranially respect the taken landmark through the skin until the penetration of the internal and external oblique fascias, identified as sudden lowering of resistance. A solution of 15 ml of Ropivacaine (0.2%) is then injected. The procedure is performed then 2 cm caudal to the first landmark on the same side. The procedure is than repeated identically on the contralateral side.
Intervention Type
Procedure
Intervention Name(s)
ultrasound-assisted Transversus Abdominis Plane (TAP) block
Intervention Description
Whilst the patient is in the supine position, a high frequency ultrasound probe is placed transverse to the abdominal wall between the costal margin and iliac crest. The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles. Then 15 ml of local anaesthetic solution is injected. The needle is than retracted until its tip is positioned in the fascial plane between the internal and the external oblique muscles and a second bolus of 15 ml of local anaesthetic is injected. The procedure is than repeated identically on the contralateral side.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
a solution of 15 ml of Ropivacaine (0.2%) is injected for the treatment of post-operative pain after minimally invasive surgery (TAP block)
Primary Outcome Measure Information:
Title
Opioids consumption
Description
Opioid consumption measured in morphine milligram equivalents (MME) per day
Time Frame
24 hours from surgery
Secondary Outcome Measure Information:
Title
Opioid consumption within the first 48 hours after the operation
Description
Opioid consumption measured in morphine milligram equivalents (MME) per day
Time Frame
48 hours from surgery
Title
postoperative pain
Description
Postoperative pain on the visual analogue scale (VAS) at 3, 6, 12, 24 hours. This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.
Time Frame
at 3, 6, 12, 24 hours from surgery
Title
length of hospital stay
Description
number of days the participant is being hospitalized
Time Frame
during hospitalization,approximately 6 days
Title
Time required to perform the (Transversus Abdominis Plane) TAP block
Time Frame
during procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients candidates to laparoscopic colorectal surgery Signed informed consent Exclusion Criteria: Age < 18 years old Pregnancy Allergy to local anaesthetics Spinal or epidural analgesia Acute inflammatory abdominal pathologies Chronic pain syndrome Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDS)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davide La Regina, MD
Organizational Affiliation
Ente Ospedaliero Cantonale (EOC)
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale
City
Bellinzona
Country
Switzerland
Facility Name
Ospedale Regionale di Lugano, Civico e Italiano - Ente Ospedaliero Cantonale
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Compare Laparoscopic to Echographic Assisted Transversus Abdominis Plane Block in Laparoscopic Colectomy

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