NCT04735770

LTAP Block in Endometriosis Surgery - a Randomised Controlled Double-blind Trial

Laparoscopically Inserted Transversus Abdominis Plane Block Versus Wound Local Anesthesia in Laparoscopic Endometriosis Surgery: a Prospective Randomized Controlled Double-blinded LTAP-trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Oulu University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of laparoscopically inserted transversus abdominis plane block (LTAP) in comparison to local wound analgesia in laparoscopic surgery due to suspected or diagnosed peritoneal endometriosis.

Detailed description

The LTAP-trial is a prospective randomized controlled double-blinded study comparing the efficacy and safety of LTAP with local wound analgesia in laparoscopic endometriosis surgery. Patients are randomized to receive LTAP with levobupivacain and wound infiltration with placebo or wound infiltration with levobupivacain and LTAP with placebo. The primary outcome is postoperative opioid consumption measured by Patient Controlled Analgesia -pump (PCA). Secondly, subjective postoperative pain up to 24 h postoperatively will be measured by Numeric Rating Scale (NRS). Additional outcome measures are factors related to recovery and length of stay in the hospital as well as a 6 month follow-up survey regarding pain and general wellbeing after surgery. A total of 46 patients will be randomized in a proportion of 1:1.

Conditions

• Endometriosis; Peritoneum
• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine	Postoperative pain management

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-12-22
• Completion: 2023-12-22
• First posted: 2021-02-03
• Last updated: 2024-01-11

Locations

1 site across 1 country: Finland