Laparoscopic-guided TAP Block vs Epidural Analgesia

Not Applicable

Recruiting

• Conditions: Post Operative Pain

• Registration Number: NCT05214261
• Lead Sponsor: Oulu University Hospital

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.

Study Timeline

• Study First Submitted: 2021-11-16
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-17
• Last Update Submitted: 2022-01-17
• Study First Posted: 2022-01-28
• Last Update Posted: 2022-01-28
• Study Start: 2022-02-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Length of post-operative hospital stay after elective laparoscopic colorectal surgery.	Up to 1 month	The primary endpoint in this study is the length of post-operative hospital stay after elective laparoscopic colorectal surgery

Secondary Outcome Measures

Name	Time	Method
Time to first flatus	Up to 1 month	Post-operative flatus
Overall benefit of analgesia score (OBAS)	Up to 1 month	The scores range 0 - 24. Low OBAS socre indicates high benefit of analgesia
Overall operating theatre time	Up to 10 hours	Overall operating theatre time
Post-operative morphine milligram equivalents recruitments	Up to 1 month	Post-operative morphine recruiments
Time to post-operative mobilization	Up to 1 month	Post-operative mobilization
Visual analogue scale	Up to 1 month	The scores range 1 to 10. Higher scores indicates worse outcome in the treatment of anelgesia.
Hospital readmission	30 and 90-day	Post-operative readmissions
Overall cost-effectiveness	Up to 6 months	Overall cost-effectiveness
Time to first bowel movement	Up to 1 month	Post-operative bowel movement
Post-operative complications related to interventions according to Clavien-Dindo classification	30 and 90-day	Post-operative complications

Trial Locations

Locations (1)

Surgery and Intensive Care Research Unit; 🇫🇮 Oulu, Finland