Title
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
Phase
Phase 4Lead Sponsor
Saint-Joseph UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Obstetric PainIntervention/Treatment
intrathecal morphine Ropivacaine (Ropivacaina Molteni®) ...Study Participants
60Cesarean 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.
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.
Cesarean section was conducted under spinal anesthesia in both groups
Intrathecal morphine was administered during spinal anesthesia in the placebo group but not in the ropivacaine group
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.
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.
Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
Ropivacaine group parturients will receive spinal anesthesia without intrathecal morphine and will have continuous ropivacaine (Ropivacaina Molteni®) wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
Inclusion Criteria: women. age between 18 and 50 years. gestational age 37 to 42 weeks. body mass index ranging from 18.0 to 30.0 kg/m2 American Society of Anesthesiology (ASA) physical status I or II elective cesarean delivery with a Pfannenstiel incision spinal anesthesia. Exclusion Criteria: history of chronic opioid use. Allergy to opioids and or local anesthetics. absolute or relative contraindication to neuraxial anesthesia. fever or any other sign of infection. Diabetes Mellitus under insulin therapy physical separation of patients from the neonate during the postoperative period.
