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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometriosis; Peritoneum, Postoperative Pain

Intervention / Treatment
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* Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTAP<br>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<br>* Postoperative pain management<br>|
| Active Comparator: Local wound analgesia<br>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<br>* Postoperative pain management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | 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) | 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) | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, postoperative pain management, laparoscopic surgery, gynecological surgery