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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626753
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Fethi Jebali, 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.

Condition or disease Intervention/treatment Phase
Cesarean Section; Complications, Wound, Infection (Following Delivery) Postoperative Pain Spinal Anaesthesia During the Puerperium Drug: Nefopam 20 MG/ML Drug: "Nefopam (Acupan)" 20 MG/ML Injectable Solution Drug: "Acetaminophen, (paracetamol)" 500Mg Tab Drug: (Acetaminophen "paracetamol") IV Soln 10 MG/ML Drug: (Piroxicam "piroxan") 20 MG Oral Tablet Drug: (Piroxicam "piroxan") 20Mg/1mL Injection Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section Oral vs Intravenous
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : June 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Oral Group
received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Drug: Nefopam 20 MG/ML
given by Oral route the dose of 20mg every 6 hours.
Other Name: 2 ampoule

Drug: "Acetaminophen, (paracetamol)" 500Mg Tab
2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.
Other Name: 2 tablets

Drug: (Piroxicam "piroxan") 20 MG Oral Tablet
2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.
Other Name: 2 tablets

Active Comparator: Intravenous group
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
given by intravenous route at the dose of 20mg every 6 hours.
Other Name: 2 ampoule

Drug: (Acetaminophen "paracetamol") IV Soln 10 MG/ML
Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.
Other Name: 1 ampoule: 1g

Drug: (Piroxicam "piroxan") 20Mg/1mL Injection
2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.
Other Name: 2 ampoules




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. morphine consumption [ Time Frame: 24 hours postoperative ]
    morphine consumption

  2. sides effects [ 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)

  3. postoperative complications [ Time Frame: 24 hours post operative ]
    The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626753


Locations
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Tunisia
Centre de Maternité de Monastir
Monastir, Tunisia, 5000
Sponsors and Collaborators
Centre de Maternité de Monastir
Publications:
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Responsible Party: Fethi Jebali, Medical doctor, clinical professor of Anesthesiology and intensive care medecine, Centre de Maternité de Monastir
ClinicalTrials.gov Identifier: NCT03626753    
Other Study ID Numbers: CMNMonastir
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fethi Jebali, Centre de Maternité de Monastir:
Pain
multimodal
analgesia
postoperative
cesarean section
obstetric
Agents
Physiological effects of drugs
opioid
Paracetamol
NSAIDs
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Piroxicam
Nefopam
Proroxan
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Psychotropic Drugs