Postoperative Pain
Conditions
Keywords
cesarean section, spinal anesthesia, continuous wound infiltration, intrathecal morphine, oral morphine
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.
Interventions
DRUGRopivacaine
Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)
DRUGMorphine
Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period
Sponsors
Maternite Regionale Universitaire
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Elective Cesarean section * Spinal anesthesia * Singleton * ASA ( Physical status score) 1 to 3
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morphine consumption during the first 48 postoperative hours | at the 48th hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to restoration of bowel function | within the first 48 postoperative hours | — |
| 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 | — |
| 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 | — |
| 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 | — |
| Number of patients that required local anesthetic rescue dose through the catheter | At the 24th and 48th hour | — |
Countries
France
Contacts
Primary ContactFlorence VIAL, MD
Backup ContactPhilippe GUERCI, MD
Outcome results
None listed