An interventional study of Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine in Endometriosis; Peritoneum and Postoperative Pain, sponsored by Oulu University Hospital. Completed at 1 site in Finland. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by Oulu University Hospital · Not applicable, Interventional, and Treatment
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.
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 46 is below the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Oulu University Hospital is the lead sponsor of 39 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Postoperative opioid consumption
Oxicodone consumption measured via PCA-pump in Morphine equivalents
Time frame: 24 hours
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Up to 6 months postop
Plan to share: No — Anonymised data can be shared upon reasonable request to the authors.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Oulu University Hospital