A randomized double blind, multicenter trial to assess time-interval between cytoreductive surgery and adjuvant chemotherapy after administration of local anesthetic intraperitoneally/perioperatively in advanced epithelial ovarian cancer - IPLA-OVCA
Phase 1
- Conditions
- Advanced epithelial ovarian cancer stage III-IVMedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507732-20-00
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
Women > 18 years, ASA I-III, Scheduled for upfront cytoreductive surgery for stage III or IV epithelial ovarian cancer, Signed written informed consent
Exclusion Criteria
Contraindication to epidural anesthesia, Allergy to any component drugs used during epidural or intraperitoneal anesthesia (Ropivacaine, Sufentanil), Uncontrolled renal, liver, heart failure or ischemic heart disease, Speech, language or cognitive difficulties, Women in whom cytoreductive surgery is not attempted at time of upfront laparotomy due to extent of disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether Ropivacaine 0.2% administered intraperitoneally during surgery and intermittently thereafter for up to 72 h in patients with stage III-IV epithelial ovarian cancer undergoing cytoreductive surgery leads to earlier start of adjuvant chemotherapy.;Secondary Objective: To evaluate postoperative complications and morbidity, quality of recovery and overall survival.;Primary end point(s): Time (days) to start of adjuvant chemotherapy after cytoreductive surgery
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Postoperative complications, postoperative morbidity, quality of recovery, cardiac and renal impairment and overall survival