Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section Oral vs Intravenous
Overview
- Phase
- Phase 2
- Intervention
- Nefopam 20 MG/ML
- Conditions
- Cesarean Section; Complications, Wound, Infection (Following Delivery)
- Sponsor
- Centre de Maternité de Monastir
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS) pain
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Fethi Jebali
Medical doctor, clinical professor of Anesthesiology and intensive care medecine
Centre de Maternité de Monastir
Eligibility Criteria
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,
Arms & Interventions
Oral Group
received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Intervention: Nefopam 20 MG/ML
Oral Group
received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Intervention: "Acetaminophen, (paracetamol)" 500Mg Tab
Oral Group
received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Intervention: (Piroxicam "piroxan") 20 MG Oral Tablet
Intravenous group
received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Intervention: "Nefopam (Acupan)" 20 MG/ML Injectable Solution
Intravenous group
received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Intervention: (Acetaminophen "paracetamol") IV Soln 10 MG/ML
Intravenous group
received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Intervention: (Piroxicam "piroxan") 20Mg/1mL Injection
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS) pain
Time Frame: 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 Outcomes
- morphine consumption(24 hours postoperative)
- sides effects(24 hours postoperative)
- postoperative complications(24 hours post operative)