Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section

Study Overview
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Brief Summary
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Many drugs with various mechanisms of action are used for postcaesarean pain relief. Although the response to pain relief is sometimes believed to be individual, it is very important to establish the most effective with the least adverse effects type of oral analgesia for women after caesarean section. Optimal pain control post-caesarean section will benefit not only the mother and her baby, but also a healthcare system. Optimal pain control may shorten the time spent in hospital after caesarean section and, therefore, reduce healthcare costs.

Detailed Description
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Pain after cesarean section (CS), usually described as strong, is an obstacle to good mother-child interaction and post-operative rehabilitation. Its management is important for a quick recovery and allow the mother to take care and link with her newborn. Currently, intrathecal opioids are the most commonly used technique and provide the foundation for post-cesarean analgesia. This technique combined with multimodal analgesia reduces the doses of morphine consumed, including these side effects. Spinal anesthesia is the standard anesthetic technique for caesarean section; it offers several advantages including the possibility of prescribing oral analgesics. An ideal analgesic protocol is one that is simple to implement, cost-effective, and has minimal impact on the work staff. It would have a good safety profile, a low incidence of side effects and complications, and respond to wide inter-patient variability. It relieves the mother of high quality pain while having minimal interference with her, newborn care and anesthesia while allowing safe breastfeeding. The aim of this work is to compare the quality of an multimodal oral analgesia with intravenous analgesia and to demonstrate non-inferiority of the oral route pain relieve in postoperative caesarean section period. The secondary objectives was to evaluate the maternal tolerance of the drugs (piroxicam, nefopam, paracetamol) used postoperatively of a caesarean section.

Official Title
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Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section Oral vs Intravenous

Conditions
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Cesarean Section; Complications, Wound, Infection (Following Delivery), Postoperative Pain, Spinal Anaesthesia During the Puerperium

Intervention / Treatment
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* Drug: Nefopam 20 MG/ML
* Drug: Nefopam (Acupan) 20 MG/ML Injectable Solution
* Drug: Acetaminophen, (paracetamol) 500Mg Tab
* Drug: (Acetaminophen paracetamol) IV Soln 10 MG/ML
* Drug: (Piroxicam piroxan) 20 MG Oral Tablet
* Drug: (Piroxicam piroxan) 20Mg/1mL Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant in singleton pregnancy with gestational age > 34 weeks American society of anesthesiologists (ASA) physical status I-II. Exclusion Criteria: history of gastrointestinal disorders predisposing to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis, an active peptic ulcer, an inflammatory gastrointestinal disorder or a gastrointestinal haemorrhage, parturients who present preeclampsia, premature delivery (<32 weeks), constitutional or acquired coagulopathy, An antecedent of hemorrhage of the delivery, a hemorrhagic complication postoperatively, Anemia (hemoglobin less than 8g / 100ml), conversion of spinal anesthesia into general anesthesia, women with severe medical conditions: renal failure (preoperative creatinine clearance <30ml / min), heart or liver failure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Group<br>received in post operative period oral analgesia ( nefopam (Acupan) 20mg/6h, piroxicam (piroxan) 40mg/24h, Acetaminophen (paracetamol) 1g/6h) | Drug: Nefopam 20 MG/ML<br>* given by Oral route the dose of 20mg every 6 hours.<br>* Other names: 2 ampoule;Drug: Acetaminophen, (paracetamol) 500Mg Tab<br>* 2 tablets of Acetaminophen (paracetamol) 500Mg Tab administrated orally every 6 hours.<br>* Other names: 2 tablets;Drug: (Piroxicam piroxan) 20 MG Oral Tablet<br>* 2 tablets of piroxicam (piroxan) administrated orally once per 24 hours.<br>* Other names: 2 tablets;|
| Active Comparator: Intravenous group<br>received in post operative period intravenous analgesia ( nefopam (Acupan) 20mg/6h, piroxicam (piroxan) 40mg/24h, Acetaminophen (paracetamol) 1g/6h) | Drug: Nefopam (Acupan) 20 MG/ML Injectable Solution<br>* given by intravenous route at the dose of 20mg every 6 hours.<br>* Other names: 2 ampoule;Drug: (Acetaminophen paracetamol) IV Soln 10 MG/ML<br>* Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.<br>* Other names: 1 ampoule: 1g;Drug: (Piroxicam piroxan) 20Mg/1mL Injection<br>* 2 ampoules of (piroxicam piroxan) administrated intravenously once per 24 hours.<br>* Other names: 2 ampoules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) pain | from 0 - 10 (with 0 being no pain and 10 being the most severe pain imaginable) at rest and coughing or mobilization | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption | morphine consumption | 24 hours postoperative | 
| sides effects | the occurrence of any undesirable effects related to the administration of any of the 3 drugs (nausea, vomiting, diarrhea, malaise, hypotension, sweating, convulsion, dryness of the mouth, tachycardia, palpitations, vertigo, allergic reactions) | 24 hours postoperative | 
| postoperative complications | The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc). | 24 hours post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, multimodal, analgesia, postoperative, cesarean section, obstetric, Agents, Physiological effects of drugs, opioid, Paracetamol, NSAIDs