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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTAP | Experimental | Patients receive laparoscopically inserted TAP block with levobupivacain and local wound anesthesia injections with saline. |
|
| Local wound analgesia | Active Comparator | Patients receive laparoscopically inserted TAP block with saline and local wound anesthesia injections with levobupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine | Procedure | Postoperative pain management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative opioid consumption | Oxicodone consumption measured via PCA-pump in Morphine equivalents | 24 hours |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sari Koivurova, MD, PhD | Oulu University Hospital, Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu mUniversity Hospital | Oulu | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42062238 | Derived | Terho AM, Puhto T, Laru J, Uimari O, Ohtonen P, Rautio T, Koivurova S. Laparoscopically guided transversus abdominis plane block versus local wound infiltration analgesia in laparoscopic surgery for peritoneal endometriosis: A prospective randomized controlled double-blinded LTAP-trial. Acta Obstet Gynecol Scand. 2026 Jun;105(6):1032-1042. doi: 10.1111/aogs.70220. Epub 2026 Apr 30. | |
| 35042563 |
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Anonymised data can be shared upon reasonable request to the authors.
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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 |
| Derived |
| Terho A, Puhto T, Laru J, Uimari O, Ohtonen P, Rautio T, Koivurova S. Laparoscopically guided transversus abdominis plane block versus local wound analgesia in laparoscopic surgery for peritoneal endometriosis: study protocol for a prospective randomized controlled double-blinded LTAP-trial. Trials. 2022 Jan 18;23(1):55. doi: 10.1186/s13063-022-06004-6. |
| D000091662 | Genital Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |