NCT03626753

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Centre de Maternité de Monastir · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Nefopam 20 MG/ML	given by Oral route the dose of 20mg every 6 hours.
DRUG	"Nefopam (Acupan)" 20 MG/ML Injectable Solution	given by intravenous route at the dose of 20mg every 6 hours.
DRUG	"Acetaminophen, (paracetamol)" 500Mg Tab	2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.
DRUG	(Acetaminophen "paracetamol") IV Soln 10 MG/ML	Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.
DRUG	(Piroxicam "piroxan") 20 MG Oral Tablet	2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.
DRUG	(Piroxicam "piroxan") 20Mg/1mL Injection	2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-06-30
• Completion: 2015-06-30
• First posted: 2018-08-13
• Last updated: 2018-08-15

Locations

1 site across 1 country: Tunisia