Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section
- Conditions
- Postoperative PainSpinal Anaesthesia During the PuerperiumCesarean Section; Complications, Wound, Infection (Following Delivery)
- Interventions
- Drug: "Nefopam (Acupan)" 20 MG/ML Injectable SolutionDrug: (Acetaminophen "paracetamol") IV Soln 10 MG/MLDrug: "Acetaminophen, (paracetamol)" 500Mg TabDrug: (Piroxicam "piroxan") 20 MG Oral TabletDrug: (Piroxicam "piroxan") 20Mg/1mL Injection
- Registration Number
- NCT03626753
- Lead Sponsor
- Centre de Maternité de Monastir
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
- Pregnant in singleton pregnancy with gestational age > 34 weeks
- American society of anesthesiologists (ASA) physical status I-II.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous group (Acetaminophen "paracetamol") IV Soln 10 MG/ML received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h) Oral Group Nefopam 20 MG/ML received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h) Oral Group "Acetaminophen, (paracetamol)" 500Mg Tab received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h) Oral Group (Piroxicam "piroxan") 20 MG Oral Tablet received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h) Intravenous group "Nefopam (Acupan)" 20 MG/ML Injectable Solution received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h) Intravenous group (Piroxicam "piroxan") 20Mg/1mL Injection received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
- Primary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) pain 24 hours postoperative from 0 - 10 (with 0 being no pain and 10 being the most severe pain imaginable) at rest and coughing or mobilization
- Secondary Outcome Measures
Name Time Method morphine consumption 24 hours postoperative morphine consumption
sides effects 24 hours postoperative 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)
postoperative complications 24 hours post operative The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc).
Trial Locations
- Locations (1)
Centre de Maternité de Monastir
🇹🇳Monastir, Tunisia