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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003299-38-SE

Enrollment

220

Registered

2019-10-18

Start date

2019-11-29

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer stage III-IV MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Ropivacain 2 mg/ml Product Name: Ropivacain 2 mg/ml Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intraperitoneal use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): • Post-operative complications • Post-operative morbidity • Quality of recovery • Cardiac and renal impairment • Overall survival at 3 and 5-years ;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	—

Countries

Sweden

Contacts

Public ContactDepartment of Pelvic Cancer

Karolinska University Hospital

sahar.salehi@sll.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026