Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2015
CompletedFirst Submitted
Initial submission to the registry
July 31, 2018
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedAugust 15, 2018
August 1, 2018
6 months
July 31, 2018
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
24 hours postoperative
Secondary Outcomes (3)
morphine consumption
24 hours postoperative
sides effects
24 hours postoperative
postoperative complications
24 hours post operative
Study Arms (2)
Oral Group
ACTIVE COMPARATORreceived in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Intravenous group
ACTIVE COMPARATORreceived in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Interventions
given by Oral route the dose of 20mg every 6 hours.
given by intravenous route at the dose of 20mg every 6 hours.
2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.
Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.
2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.
2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.
Eligibility Criteria
You may qualify if:
- Pregnant in singleton pregnancy with gestational age \> 34 weeks
- American society of anesthesiologists (ASA) physical status I-II.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Maternité de Monastir
Monastir, 5000, Tunisia
Related Publications (2)
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.
PMID: 28928554BACKGROUNDMkontwana 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.
PMID: 25821010BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor, clinical professor of Anesthesiology and intensive care medecine
Study Record Dates
First Submitted
July 31, 2018
First Posted
August 13, 2018
Study Start
January 1, 2015
Primary Completion
June 30, 2015
Study Completion
June 30, 2015
Last Updated
August 15, 2018
Record last verified: 2018-08