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Clinical Trials/NCT04575233
NCT04575233
Completed
Not Applicable

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

Davide La Regina2 sites in 1 country116 target enrollmentJanuary 15, 2018

Overview

Phase
Not Applicable
Intervention
laparoscopic-assisted Transversus Abdominis Plane (TAP) block
Conditions
Laparoscopic Colectomy
Sponsor
Davide La Regina
Enrollment
116
Locations
2
Primary Endpoint
Opioids consumption
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 15, 2018
End Date
January 11, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Davide La Regina
Responsible Party
Sponsor Investigator
Principal Investigator

Davide La Regina

Principal Investigator

Ente Ospedaliero Cantonale, Bellinzona

Eligibility Criteria

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)

Arms & Interventions

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

Intervention: laparoscopic-assisted Transversus Abdominis Plane (TAP) block

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

Intervention: Ropivacaine

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

Intervention: ultrasound-assisted Transversus Abdominis Plane (TAP) block

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

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Opioids consumption

Time Frame: 24 hours from surgery

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

Secondary Outcomes

  • 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)
  • postoperative pain(at 3, 6, 12, 24 hours from surgery)
  • length of hospital stay(during hospitalization,approximately 6 days)

Study Sites (2)

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