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

• ClinicalTrials.gov Identifier: NCT03626753
• Recruitment Status: Completed
• First Posted: August 13, 2018
• Last Update Posted: August 15, 2018
• Sponsor: Centre de Maternité de Monastir
• Information provided by (Responsible Party): Fethi Jebali, Centre de Maternité de Monastir

Tracking Information

• First Submitted Date: July 31, 2018
• First Posted Date: August 13, 2018
• Last Update Posted Date: August 15, 2018
• Actual Study Start Date: January 1, 2015
• Actual Primary Completion Date: June 30, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

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

Intervention

• 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

• 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 *

• Mahajan L, Mittal V, Gupta R, Chhabra H, Vidhan J, Kaur A. Study to Compare the Effect of Oral, Rectal, and Intravenous Infusion of Paracetamol for Postoperative Analgesia in Women Undergoing Cesarean Section Under Spinal Anesthesia. Anesth Essays Res. 2017 Jul-Sep;11(3):594-598. doi: 10.4103/0259-1162.206872.
• Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. Cochrane Database Syst Rev. 2015 Mar 29;2015(3):CD010450. doi: 10.1002/14651858.CD010450.pub2.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 9, 2018): 200
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 30, 2015
• Actual Primary Completion Date: June 30, 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Tunisia

Administrative Information

• NCT Number: NCT03626753
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: Fethi Jebali, Centre de Maternité de Monastir
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre de Maternité de Monastir
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centre de Maternité de Monastir
• Verification Date: August 2018