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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Tunisia
Study Type
Interventional
Intervention
Nefopam 20 MG/ML
"Nefopam (Acupan)" 20 MG/ML Injectable Solution
"Acetaminophen, (paracetamol)" 500Mg Tab
(Acetaminophen "paracetamol") IV Soln 10 MG/ML
(Piroxicam "piroxan") 20 MG Oral Tablet
(Piroxicam "piroxan") 20Mg/1mL Injection
Sponsored by
Centre de Maternité de Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section; Complications, Wound, Infection (Following Delivery) focused on measuring Pain, multimodal, analgesia, postoperative, cesarean section, obstetric, Agents, Physiological effects of drugs, opioid, Paracetamol, NSAIDs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre de Maternité de Monastir

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oral Group

Intravenous group

Arm Description

received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)

received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

morphine consumption
morphine consumption
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)
postoperative complications
The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc).

Full Information

First Posted
July 31, 2018
Last Updated
August 13, 2018
Sponsor
Centre de Maternité de Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT03626753
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
June 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Maternité de Monastir

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section; Complications, Wound, Infection (Following Delivery), Postoperative Pain, Spinal Anaesthesia During the Puerperium
Keywords
Pain, multimodal, analgesia, postoperative, cesarean section, obstetric, Agents, Physiological effects of drugs, opioid, Paracetamol, NSAIDs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Group
Arm Type
Active Comparator
Arm Description
received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Arm Title
Intravenous group
Arm Type
Active Comparator
Arm Description
received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Intervention Type
Drug
Intervention Name(s)
Nefopam 20 MG/ML
Other Intervention Name(s)
2 ampoule
Intervention Description
given by Oral route the dose of 20mg every 6 hours.
Intervention Type
Drug
Intervention Name(s)
"Nefopam (Acupan)" 20 MG/ML Injectable Solution
Other Intervention Name(s)
2 ampoule
Intervention Description
given by intravenous route at the dose of 20mg every 6 hours.
Intervention Type
Drug
Intervention Name(s)
"Acetaminophen, (paracetamol)" 500Mg Tab
Other Intervention Name(s)
2 tablets
Intervention Description
2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.
Intervention Type
Drug
Intervention Name(s)
(Acetaminophen "paracetamol") IV Soln 10 MG/ML
Other Intervention Name(s)
1 ampoule: 1g
Intervention Description
Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.
Intervention Type
Drug
Intervention Name(s)
(Piroxicam "piroxan") 20 MG Oral Tablet
Other Intervention Name(s)
2 tablets
Intervention Description
2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.
Intervention Type
Drug
Intervention Name(s)
(Piroxicam "piroxan") 20Mg/1mL Injection
Other Intervention Name(s)
2 ampoules
Intervention Description
2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) pain
Description
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
Secondary Outcome Measure Information:
Title
morphine consumption
Description
morphine consumption
Time Frame
24 hours postoperative
Title
sides effects
Description
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
Title
postoperative complications
Description
The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc).
Time Frame
24 hours post operative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Centre de Maternité de Monastir
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28928554
Citation
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.
Results Reference
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PubMed Identifier
25821010
Citation
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.
Results Reference
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Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section

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