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

NCT04575233 | Completed

• 1 other identifier: TAP block
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

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

Conditions

Laparoscopic Colectomy; Pain, Postoperative

Keywords

Transversus Abdominis Plane (TAP) Block; Local Anesthetic Infiltrations

Outcome Measures

Primary Outcomes (1)

• Opioids consumption

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

  24 hours from surgery

Secondary Outcomes (4)

• Opioid consumption within the first 48 hours after the operation

  48 hours from surgery

• postoperative pain

  at 3, 6, 12, 24 hours from surgery

• length of hospital stay

  during hospitalization,approximately 6 days

• Time required to perform the (Transversus Abdominis Plane) TAP block

  during procedure

Study Arms (2)

Laparoscopic Transversus Abdominis Plane (L-TAP) group

EXPERIMENTAL

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; Drug: Ropivacaine

Ultrasound Transversus Abdominis Plane (U-TAP) group

ACTIVE COMPARATOR

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

Procedure: ultrasound-assisted Transversus Abdominis Plane (TAP) block; Drug: Ropivacaine

Interventions

laparoscopic-assisted Transversus Abdominis Plane (TAP) block PROCEDURE

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.

Laparoscopic Transversus Abdominis Plane (L-TAP) group

ultrasound-assisted Transversus Abdominis Plane (TAP) block PROCEDURE

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.

Ultrasound Transversus Abdominis Plane (U-TAP) group

Ropivacaine DRUG

a solution of 15 ml of Ropivacaine (0.2%) is injected for the treatment of post-operative pain after minimally invasive surgery (TAP block)

Laparoscopic Transversus Abdominis Plane (L-TAP) group; Ultrasound Transversus Abdominis Plane (U-TAP) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients candidates to laparoscopic colorectal surgery
• Signed informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Davide La Regina: lead

Study Sites (2)

Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale

Bellinzona, Switzerland

Location

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

Lugano, 6900, Switzerland

Location

Related Publications (1)

• La Regina D, Popeskou SG, Saporito A, Gaffuri P, Tasciotti E, Dossi R, Christoforidis D, Mongelli F. Laparoscopic versus ultrasound-guided transversus abdominis plane block in colorectal surgery: a non-inferiority, multicentric randomized double-blinded clinical trial. Colorectal Dis. 2023 Sep;25(9):1921-1928. doi: 10.1111/codi.16689. Epub 2023 Jul 31.

  PMID: 37525414 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Bites and Stings

Interventions

Dental Occlusion; Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Davide La Regina, MD

  Ente Ospedaliero Cantonale (EOC)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 5, 2020
• Study Start: January 15, 2018
• Primary Completion: January 11, 2022
• Study Completion: January 11, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)