Endometriosis; Peritoneum, Postoperative Pain
Conditions
Keywords
endometriosis, postoperative pain management, laparoscopic surgery, gynecological surgery
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.
Interventions
PROCEDUREPostoperative pain management: LTAP block or local wound anesthesia with levobupivacaine
Postoperative pain management
Sponsors
Oulu University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative opioid consumption | 24 hours | Oxicodone consumption measured via PCA-pump in Morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
Countries
Finland
Outcome results
None listed