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

January 10, 2024 updated by: Anna Terho, Oulu University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Oulu, Finland
        • Oulu mUniversity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LTAP
Patients receive laparoscopically inserted TAP block with levobupivacain and local wound anesthesia injections with saline.
Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine
Postoperative pain management
Active Comparator: Local wound analgesia
Patients receive laparoscopically inserted TAP block with saline and local wound anesthesia injections with levobupivacaine.
Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine
Postoperative pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: 24 hours
Oxicodone consumption measured via PCA-pump in Morphine equivalents
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain assessed by NRS (numeric rating scale)
Time Frame: 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
Recovery room immediately postoperatively; on ward 6, 12 and 24 hours postoperatively
Pain at six months postoperatively; assessed by NRS (numeric rating scale), (questionnaires sent to the patients)
Time Frame: 6 months postop
NRS (numeric rating scale) with 0 (minimum) meaning no pain and 10 (maximum) meaning the worst imaginable pain
6 months postop
Quality of life at six months postoperatively; assessed by EHP-30 (endometriosis-related health profile) (questionnaires sent to the patients)
Time Frame: 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
6 months postop
Intra- or postoperative complications
Time Frame: 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)
Up to 6 months postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oulu University Hospital

Investigators

  • Principal Investigator: Sari Koivurova, MD, PhD, Oulu University Hospital, Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

December 22, 2023

Study Completion (Actual)

December 22, 2023

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OuluUH/Urogyn

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymised data can be shared upon reasonable request to the authors.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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