Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 29, 2017

Primary Completion Date

May 29, 2018

Study Completion Date

June 29, 2018

Conditions
Obstetric Pain
Interventions
DEVICE

wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)

After peritoneum closure a 16cm multiorifice perforated catheter (Dosi-Pain® Kit, LEVENTON SAU, Spain) was inserted by the surgeon below the fascia used for normal saline continuous infusion in the Placebo group and for continuous ropivacaine infusion (Ropivacaina Molteni®, MOLTENI FARMACEUTICI, Italy) in the ropivacaine group.

PROCEDURE

Spinal Anesthesia

Cesarean section was conducted under spinal anesthesia in both groups

DRUG

intrathecal morphine

Intrathecal morphine was administered during spinal anesthesia in the placebo group but not in the ropivacaine group

DRUG

Ropivacaine (Ropivacaina Molteni®)

A10ml bolus of ropivacaine 7.5mg/ml were administered in the wound catheter after skin closure then an infusion of ropivacaine 2mg/ml at the rate of 5ml/h was administered as wound infusion via the Dosi-Pain® Kit for 48hours.

DRUG

Normal saline

A10ml bolus of normal saline were administered in the wound catheter after skin closure then an infusion of normal saline at the rate of 5ml/h was administered as wound infusion via the Dosi-Pain® Kit for 48hours.

Trial Locations (1)

166830

Hotel Dieu de France Hospital, Beirut

All Listed Sponsors
collaborator

LEVENTON

UNKNOWN

lead

Saint-Joseph University

OTHER

NCT03502642 - Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery | Biotech Hunter | Biotech Hunter