Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section

Study Overview
=================
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.

Official Title
-----------------
Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section. Controlled Comparative Study.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous wound infiltration alone<br>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. | Drug: Ropivacaine<br>* Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)<br>|
| Active Comparator: Intrathecal moprhine alone<br>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. | Drug: Morphine<br>* Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period<br>|
| Experimental: Intrathecal morphine&wound infiltration<br>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. | Drug: Ropivacaine<br>* Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)<br>Drug: Morphine<br>* Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption during the first 48 postoperative hours |  | at the 48th hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest and at mobilization | 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 | Every 4 hours during the first 48 postoperative hours | 
| 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 | 
| Number of patients that required local anesthetic rescue dose through the catheter |  | At the 24th and 48th hour | 
| Postoperative rehabilitation survey |  | At the 48th hour | 
| Occurrence of side effect | Itching, nausea and vomiting, drowsiness, urinary retention, hypoventilation, other will be assessed with a questionnaire | During the first 48 hours | 
| Postoperative residual pain (DN4 survey) |  | At 3 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean section, spinal anesthesia, continuous wound infiltration, intrathecal morphine, oral morphine