A Phase 2/3 interventional study of Nefopam 20 MG/ML and "Nefopam (Acupan)" 20 MG/ML Injectable Solution in Cesarean Section; Complications, Wound, Infection (Following Delivery), Postoperative Pain and Spinal Anaesthesia During the Puerperium, sponsored by Centre de Maternité de Monastir. Completed at 1 site in Tunisia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-15.
Sponsored by Centre de Maternité de Monastir · Phase 2/3, Interventional, and Treatment
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.
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.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's enrollment of 200 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Centre de Maternité de Monastir is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Drug: Nefopam 20 MG/ML · Drug: "Acetaminophen, (paracetamol)" 500Mg Tab · Drug: (Piroxicam "piroxan") 20 MG Oral Tablet
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 · Drug: (Acetaminophen "paracetamol") IV Soln 10 MG/ML · Drug: (Piroxicam "piroxan") 20Mg/1mL Injection
Drug page: Nefopam
given by Oral route the dose of 20mg every 6 hours.
Also known as: 2 ampoule
Drug page: Nefopam
given by intravenous route at the dose of 20mg every 6 hours.
Also known as: 2 ampoule
2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.
Also known as: 2 tablets
Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.
Also known as: 1 ampoule: 1g
2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.
Also known as: 2 tablets
2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.
Also known as: 2 ampoules
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
Time frame: 24 hours postoperative
morphine consumption
morphine consumption
Time frame: 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)
Time frame: 24 hours postoperative
postoperative complications
The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc).
Time frame: 24 hours post operative
Plan to share: Undecided
Ran from Jan 2015 to primary completion in Jun 2015, 5 months.
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Studies of the drugs tested here: Nefopam · Acetaminophen
Centre de Maternité de Monastir