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

Not Applicable

Completed

• Conditions: Laparoscopic Colectomy; Pain, Postoperative
• Interventions: Procedure: laparoscopic-assisted Transversus Abdominis Plane (TAP) block; Procedure: ultrasound-assisted Transversus Abdominis Plane (TAP) block; Drug: Ropivacaine

• Registration Number: NCT04575233
• Lead Sponsor: Davide La Regina

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-05
• Primary Completion: 2022-01-11
• Study Completion: 2022-01-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Transversus Abdominis Plane (L-TAP) group	laparoscopic-assisted Transversus Abdominis Plane (TAP) block	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
Ultrasound Transversus Abdominis Plane (U-TAP) group	ultrasound-assisted Transversus Abdominis Plane (TAP) block	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
Laparoscopic Transversus Abdominis Plane (L-TAP) group	Ropivacaine	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
Ultrasound Transversus Abdominis Plane (U-TAP) group	Ropivacaine	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

Primary Outcome Measures

Name	Time	Method
Opioids consumption	24 hours from surgery	Opioid consumption measured in morphine milligram equivalents (MME) per day

Secondary Outcome Measures

Name	Time	Method
Time required to perform the (Transversus Abdominis Plane) TAP block	during procedure
Opioid consumption within the first 48 hours after the operation	48 hours from surgery	Opioid consumption measured in morphine milligram equivalents (MME) per day
postoperative pain	at 3, 6, 12, 24 hours from surgery	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	during hospitalization,approximately 6 days	number of days the participant is being hospitalized

Trial Locations

Locations (2)

Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale; 🇨🇭 Bellinzona, Switzerland

Ospedale Regionale di Lugano, Civico e Italiano - Ente Ospedaliero Cantonale; 🇨🇭 Lugano, Switzerland