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Clinical Trials/NCT05214261
NCT05214261
Recruiting
Not Applicable

Laparoscopic-Guided Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colorectal Laparoscopic Surgery. A Protocol for a Randomized Clinical Trial

Oulu University Hospital1 site in 1 country210 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Operative Pain
Sponsor
Oulu University Hospital
Enrollment
210
Locations
1
Primary Endpoint
Length of post-operative hospital stay after elective laparoscopic colorectal surgery.
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

The LAPTAP trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery.

Detailed Description

In most previous studies TAP-block has been inserted by anesthesiologist under ultrasound guidance. TAP blockade can alternatively be performed by a surgeon with laparoscopic visual guidance during trocar placement by aiming injection into fascial plane between the internal oblique and transversus abdominis in the midaxillary line and repeated on the contralateral side. There is lack in studies comparing laparoscopic guided TAP-blockade versus epidural pain analgesia in elective laparoscopic colon surgery exist.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
December 31, 2025
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heikki Huhta

Gastointestinal Surgeon, Adjunct Professor

Oulu University Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Length of post-operative hospital stay after elective laparoscopic colorectal surgery.

Time Frame: Up to 1 month

The primary endpoint in this study is the length of post-operative hospital stay after elective laparoscopic colorectal surgery

Secondary Outcomes

  • Time to first flatus(Up to 1 month)
  • Overall benefit of analgesia score (OBAS)(Up to 1 month)
  • Overall operating theatre time(Up to 10 hours)
  • Post-operative morphine milligram equivalents recruitments(Up to 1 month)
  • Time to post-operative mobilization(Up to 1 month)
  • Visual analogue scale(Up to 1 month)
  • Hospital readmission(30 and 90-day)
  • Overall cost-effectiveness(Up to 6 months)
  • Time to first bowel movement(Up to 1 month)
  • Post-operative complications related to interventions according to Clavien-Dindo classification(30 and 90-day)

Study Sites (1)

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