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

Laparoscopic- Vs Ultrasound-guided Transversus Abdominis Plane Block in Laparoscopic Colectomy: a Prospective Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Laparoscopic Colectomy
• Intervention / Treatment: Procedure: laparoscopic-assisted Transversus Abdominis Plane (TAP) block; Drug: Ropivacaine; Procedure: ultrasound-assisted Transversus Abdominis Plane (TAP) block

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bellinzona, Switzerland
    • Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale
  • Lugano, Switzerland, 6900
    • Ospedale Regionale di Lugano, Civico e Italiano - Ente Ospedaliero Cantonale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laparoscopic Transversus Abdominis Plane (L-TAP) group; 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	Procedure: laparoscopic-assisted Transversus Abdominis Plane (TAP) block; 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.; Drug: Ropivacaine; a solution of 15 ml of Ropivacaine (0.2%) is injected for the treatment of post-operative pain after minimally invasive surgery (TAP block)
ACTIVE_COMPARATOR: Ultrasound Transversus Abdominis Plane (U-TAP) group; 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	Drug: Ropivacaine; a solution of 15 ml of Ropivacaine (0.2%) is injected for the treatment of post-operative pain after minimally invasive surgery (TAP block); Procedure: ultrasound-assisted Transversus Abdominis Plane (TAP) block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioids consumption	Opioid consumption measured in morphine milligram equivalents (MME) per day	24 hours from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption within the first 48 hours after the operation	Opioid consumption measured in morphine milligram equivalents (MME) per day	48 hours from surgery
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.	at 3, 6, 12, 24 hours from surgery
length of hospital stay	number of days the participant is being hospitalized	during hospitalization,approximately 6 days
Time required to perform the (Transversus Abdominis Plane) TAP block		during procedure

Collaborators and Investigators

• Sponsor: Davide La Regina
• Investigators: Study Chair: Davide La Regina, MD, Ente Ospedaliero Cantonale (EOC)

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2018
• Primary Completion (ACTUAL): January 11, 2022
• Study Completion (ACTUAL): January 11, 2022

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (ACTUAL): October 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Transversus Abdominis Plane (TAP) Block; Local Anesthetic Infiltrations
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: TAP Block

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