Laparoscopically Inserted Transversus Abdominis Plane Block Versus Wound Local Anesthesia in Laparoscopic Endometriosis Surgery: a Prospective Randomized Controlled Double-blinded LTAP-trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Oulu University Hospital
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Postoperative opioid consumption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
LTAP
Patients receive laparoscopically inserted TAP block with levobupivacain and local wound anesthesia injections with saline.
Intervention: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine (Procedure)
Local wound analgesia
Patients receive laparoscopically inserted TAP block with saline and local wound anesthesia injections with levobupivacaine.
Intervention: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine (Procedure)
Outcomes
Primary Outcomes
Postoperative opioid consumption
Time Frame: 24 hours
Oxicodone consumption measured via PCA-pump in Morphine equivalents
Secondary Outcomes
- Pain at six months postoperatively; assessed by NRS (numeric rating scale), (questionnaires sent to the patients)(6 months postop)
- Postoperative pain assessed by NRS (numeric rating scale)(Recovery room immediately postoperatively; on ward 6, 12 and 24 hours postoperatively)
- Quality of life at six months postoperatively; assessed by EHP-30 (endometriosis-related health profile) (questionnaires sent to the patients)(6 months postop)
- Intra- or postoperative complications(Up to 6 months postop)
Investigators
Anna Terho
Principal Investigator
Oulu University Hospital