Clinical trial NCT04735770: LTAP Block in Endometriosis Surgery - a Randomised Controlled Double-blind Trial
Official title: Laparoscopically Inserted Transversus Abdominis Plane Block Versus Wound Local Anesthesia in Laparoscopic Endometriosis Surgery: a Prospective Randomized Controlled Double-blinded LTAP-trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis; Peritoneum
Postoperative Pain
Keywords: endometriosis
postoperative pain management
laparoscopic surgery
gynecological surgery
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative pain assessed by NRS (numeric rating scale)
timeFrame: Recovery room immediately postoperatively; on ward 6, 12 and 24 hours postoperatively
measure: Pain at six months postoperatively; assessed by NRS (numeric rating scale), (questionnaires sent to the patients)
timeFrame: 6 months postop
measure: Quality of life at six months postoperatively; assessed by EHP-30 (endometriosis-related health profile) (questionnaires sent to the patients)
timeFrame: 6 months postop
measure: Intra- or postoperative complications
timeFrame: Up to 6 months postop
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu mUniversity Hospital
Study officials:
affiliation: Oulu University Hospital, Department of Obstetrics and Gynecology
name: Sari Koivurova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.