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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

Tracking Information
First Submitted Date  ICMJE July 31, 2018
First Posted Date  ICMJE August 13, 2018
Last Update Posted Date August 15, 2018
Actual Study Start Date  ICMJE January 1, 2015
Actual Primary Completion Date June 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • morphine consumption [ Time Frame: 24 hours postoperative ]
    morphine consumption
  • 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)
  • postoperative complications [ Time Frame: 24 hours post operative ]
    The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section
Official Title  ICMJE Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section Oral vs Intravenous
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cesarean Section; Complications, Wound, Infection (Following Delivery)
  • Postoperative Pain
  • Spinal Anaesthesia During the Puerperium
Intervention  ICMJE
  • Drug: Nefopam 20 MG/ML
    given by Oral route the dose of 20mg every 6 hours.
    Other Name: 2 ampoule
  • 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)" 500Mg Tab
    2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.
    Other Name: 2 tablets
  • 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") 20 MG Oral Tablet
    2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.
    Other Name: 2 tablets
  • Drug: (Piroxicam "piroxan") 20Mg/1mL Injection
    2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.
    Other Name: 2 ampoules
Study Arms  ICMJE
  • Active Comparator: Oral Group
    received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
    Interventions:
    • Drug: Nefopam 20 MG/ML
    • Drug: "Acetaminophen, (paracetamol)" 500Mg Tab
    • Drug: (Piroxicam "piroxan") 20 MG Oral Tablet
  • Active Comparator: Intravenous group
    received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
    Interventions:
    • Drug: "Nefopam (Acupan)" 20 MG/ML Injectable Solution
    • Drug: (Acetaminophen "paracetamol") IV Soln 10 MG/ML
    • Drug: (Piroxicam "piroxan") 20Mg/1mL Injection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2018)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2015
Actual Primary Completion Date June 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03626753
Other Study ID Numbers  ICMJE CMNMonastir
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Fethi Jebali, Centre de Maternité de Monastir
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre de Maternité de Monastir
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre de Maternité de Monastir
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP