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CompletedNCT04575233Updated Jul 14, 2022

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

An interventional study of laparoscopic-assisted Transversus Abdominis Plane (TAP) block and ultrasound-assisted Transversus Abdominis Plane (TAP) block in Laparoscopic Colectomy and Pain, Postoperative, sponsored by Davide La Regina. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by Davide La Regina · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Jan 2018, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Laparoscopic Colectomy
  • Pain, Postoperative

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Keywords

  • Transversus Abdominis Plane (TAP) Block
  • Local Anesthetic Infiltrations
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In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 116 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

This is the only study on the registry with Davide La Regina as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients candidates to laparoscopic colorectal surgery
  • Signed informed consent

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
116 participants (actual)

Study arms

  • 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 · Drug: Ropivacaine

  • 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

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

Interventions

  • Procedurelaparoscopic-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.

  • Procedureultrasound-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.

  • DrugRopivacaine

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

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What researchers measure

Primary outcomes

  1. Opioids consumption

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

    Time frame: 24 hours from surgery

Secondary outcomes

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

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

    Time frame: 48 hours from surgery

  2. 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.

    Time frame: at 3, 6, 12, 24 hours from surgery

  3. length of hospital stay

    number of days the participant is being hospitalized

    Time frame: during hospitalization,approximately 6 days

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

    Time frame: during procedure

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Study locations

2 sites
  • Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale
    Bellinzona, Switzerland
  • Ospedale Regionale di Lugano, Civico e Italiano - Ente Ospedaliero Cantonale
    Lugano, 6900, Switzerland
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04575233
Lead sponsor
Davide La Regina
Responsible party
Davide La Regina (Principal Investigator, Ente Ospedaliero Cantonale, Bellinzona) — Sponsor-investigator
First posted
Oct 5, 2020
Start date
Jan 15, 2018
Primary completion
Jan 11, 2022
Completion
Jan 11, 2022
Last update
Jul 14, 2022

Study contacts

Davide La Regina, MD
study chair · Ente Ospedaliero Cantonale (EOC)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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