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

August 13, 2018 updated by: Fethi Jebali, Centre de Maternité de Monastir

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

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.

Study Overview

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

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Monastir, Tunisia, 5000
        • Centre de Maternité de Monastir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)
given by Oral route the dose of 20mg every 6 hours.
Other Names:
  • 2 ampoule
2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.
Other Names:
  • 2 tablets
2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.
Other Names:
  • 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)
given by intravenous route at the dose of 20mg every 6 hours.
Other Names:
  • 2 ampoule
Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.
Other Names:
  • 1 ampoule: 1g
2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.
Other Names:
  • 2 ampoules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine consumption
Time Frame: 24 hours postoperative
morphine consumption
24 hours postoperative
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)
24 hours postoperative
postoperative complications
Time Frame: 24 hours post operative
The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc).
24 hours post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

June 30, 2015

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

July 31, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 13, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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