NCT03502642

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

Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery : A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Saint-Joseph University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Cesarean delivery is one of the most common surgical procedures, performed at an increasingly high rate. It is associated with intense postoperative pain that may hamper the rehabilitation process and interfere with patient satisfaction and care provided to the newborn. Therefore, control of perioperative pain with multimodal regimens using local anesthetic may be important in short- and long-term convalescence after surgery. Opioid-based regimens are the "gold standard" of cesarean delivery analgesia. However, spinal and epidural opioids have a ceiling effect. Wound infiltration with local anesthetics has been used widely in the multimodal approach of pain relief. Continuous wound infusion with local anesthetic through a multiorifice catheter increases the duration of action and efficacy of local surgical wound infiltration compared with a one-time wound injection of local anesthetic. After cesarean delivery, Local anesthetic continuous wound infusion would be associated with better reduction in pain scores when compared to intrathecal morphine . Therefore, an assessor and patient blinded, randomized study that aimed to compare the efficacy and side effects of these analgesia techniques was conducted.

Conditions

• Obstetric Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-29
• Primary completion: 2018-05-29
• Completion: 2018-06-29
• First posted: 2018-04-19
• Last updated: 2018-10-09

Locations

1 site across 1 country: Lebanon