Centre de Maternité de Monastir
Monastir, 5000, Tunisia
NCT Number: NCT03626753
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.
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Notify Me18 year and older
Female
Interventional
Phase 2 / Phase 3
Monastir, 5000, Tunisia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
given by Oral route the dose of 20mg every 6 hours.
Other names: 2 ampoule
given by intravenous route at the dose of 20mg every 6 hours.
Other names: 2 ampoule
2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.
Other names: 2 tablets
Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.
Other names: 1 ampoule: 1g
2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.
Other names: 2 tablets
2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.
Other names: 2 ampoules
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
Time frame: 24 hours postoperative
morphine consumption
Time frame: 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)
Time frame: 24 hours post operative
The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc).
Centre de Maternité de Monastir
Other
Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section Oral vs Intravenous
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