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Completed

NCT Number: NCT04735770

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

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Key information

Conditions

Endometriosis; Peritoneum Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oulu mUniversity Hospital

Oulu, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine

Procedure

Postoperative pain management

Primary outcomes

  1. Postoperative opioid consumption

    Time frame: 24 hours

    Oxicodone consumption measured via PCA-pump in Morphine equivalents

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2021
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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