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

Not Applicable

Completed

• Conditions: Endometriosis; Peritoneum; Postoperative Pain

• Registration Number: NCT04735770
• Lead Sponsor: Oulu University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-03
• Study Start: 2021-05-01
• Primary Completion: 2023-12-22
• Study Completion: 2023-12-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

• Surgery indicated because of pain caused by diagnosed or suspected peritoneal endometriosis
• ASA class 1-3
• Patient is capable of giving informed consent

Exclusion Criteria

• Obstructive sleep apnea
• ASA class >4
• Other significant risks associated with opioid use
• Contraindications for local anesthetics or NSAIDs
• Regular opioid consumption before operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	24 hours	Oxicodone consumption measured via PCA-pump in Morphine equivalents

Secondary Outcome Measures

Name	Time	Method
Pain at six months postoperatively; assessed by NRS (numeric rating scale), (questionnaires sent to the patients)	6 months postop	NRS (numeric rating scale) with 0 (minimum) meaning no pain and 10 (maximum) meaning the worst imaginable pain
Postoperative pain assessed by NRS (numeric rating scale)	Recovery room immediately postoperatively; on ward 6, 12 and 24 hours postoperatively	NRS (numeric rating scale) with 0 (minimum) meaning no pain and 10 (maximum) meaning the worst imaginable pain
Quality of life at six months postoperatively; assessed by EHP-30 (endometriosis-related health profile) (questionnaires sent to the patients)	6 months postop	EHP-30 (endometriosis health profile) with 0% meaning no effect on quality of life and 100% meaning maximum worsening effect on quality of life
Intra- or postoperative complications	Up to 6 months postop	Blood loss (millilitres for each participant), Reoperation (number of participants; yes/no), Hospital stay (hours/days for each participant), Readmission (number of participants for each study group), complications according to Clavien Dindo classification (Grade I meaning any deviation from the normal postoperative course; up to grade V meaning death of patient)

Trial Locations

Locations (1)

Oulu mUniversity Hospital; 🇫🇮 Oulu, Finland