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Completed

NCT Number: NCT04575233

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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)

Primary outcomes

  1. Opioids consumption

    Time frame: 24 hours from surgery

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

Secondary outcomes

  1. Opioid consumption within the first 48 hours after the operation

    Time frame: 48 hours from surgery

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

  2. postoperative pain

    Time frame: 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.

  3. length of hospital stay

    Time frame: during hospitalization,approximately 6 days

    number of days the participant is being hospitalized

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

    Time frame: during procedure

Sponsors and collaborators

Lead sponsor

Davide La Regina

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2020
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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