Can local anesthetics given inside the abdominal cavity during and up to 72 h after surgery reduce the time to start of chemotherapy after sugery

Phase 1

Conditions: Ovarian cancer stage III-IV
MedDRA version: 20.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2019-003299-38-SE

Lead Sponsor: Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

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 from surgery to start of adjuvant chemotherapy (days);Timepoint(s) of evaluation of this end point: Number of days after surgery when adjuvant chemotherapy is first initiated

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Post-operative complications <br>•Post-operative morbidity<br>•Quality of recovery <br>•Cardiac and renal impairment<br>•Overall survival at 3 and 5-years<br>;Timepoint(s) of evaluation of this end point: Continuously during hospital stay or at re-admission for primary surgery and at 3 and 5 years after surgery