Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section
- Registration Number
- NCT02279628
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
The cesarean section is considered as a painful surgery during the post operative period. Mothers may need to move immediately after the surgery to take care of their babies. This may increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is required so that mothers do not experience pain in caring for their baby. Currently, several techniques have been developed to manage postoperative pain related to c-section scar such as intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound infiltration. The comparison between anesthetic techniques has never been performed and it is still not know if the combination of intrathecal morphine plus continuous pre-peritoneal wound infiltration provide a synergistic or additional effect on pain relief.
- Detailed Description
The aim of this study is to compare the efficacy of continuous wound infiltration versus intrathecal morphine for postoperative analgesia after scheduled cesarean section. The primary endpoint is morphine consumption during the first 48 postoperative hours.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 150
- Elective Cesarean section
- Spinal anesthesia
- Singleton
- ASA ( Physical status score) 1 to 3
- Age <18yrs
- BMI ≥ 45 kg/m2 or weight < 45 kg
- Refusal to consent
- Urgent cesarean section
- Allergy to a medication used in the protocol
- Impaired hemostasis ou current infection
- Contra indication or failure of spinal anesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous wound infiltration alone Ropivacaine Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 1 ml sodium chloride 0.9% (without morphine). Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter. Intrathecal morphine&wound infiltration Morphine Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter. Intrathecal morphine&wound infiltration Ropivacaine Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter. Intrathecal moprhine alone Morphine Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of sodium chloride 0.9% 8 ml/H via a preperitoneal catheter.
- Primary Outcome Measures
Name Time Method Morphine consumption during the first 48 postoperative hours at the 48th hour
- Secondary Outcome Measures
Name Time Method Time to restoration of bowel function within the first 48 postoperative hours Pain at rest and at mobilization Every 4 hours during the first 48 postoperative hours The pain at rest and at mobilization will be evaluated with both Visual Analog scale and Verbal pain scale. The patient should describe the worst pain felt during the previous 4 hours in a lying position and at mobilization
Postoperative rehabilitation survey At the 48th hour Verbal and Visual analog pain scores in the first standing position at day 1 Number of patients that required oral morphine At the 24th and 48th hour Number of patients that required local anesthetic rescue dose through the catheter At the 24th and 48th hour Occurrence of side effect During the first 48 hours Itching, nausea and vomiting, drowsiness, urinary retention, hypoventilation, other will be assessed with a questionnaire
Postoperative residual pain (DN4 survey) At 3 months postoperatively
Trial Locations
- Locations (1)
Maternité Régionale Universitaire (MRU)
🇫🇷Nancy, Lorraine, France