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

NCT03626753 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-08-15

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Nefopam 20 MG/ML

given by Oral route the dose of 20mg every 6 hours.

DRUG

"Nefopam (Acupan)" 20 MG/ML Injectable Solution

given by intravenous route at the dose of 20mg every 6 hours.

DRUG

"Acetaminophen, (paracetamol)" 500Mg Tab

2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.

DRUG

(Acetaminophen "paracetamol") IV Soln 10 MG/ML

Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.

DRUG

(Piroxicam "piroxan") 20 MG Oral Tablet

2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.

DRUG

(Piroxicam "piroxan") 20Mg/1mL Injection

2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.

Sponsors & Collaborators

  • Centre de Maternité de Monastir

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03626753 on ClinicalTrials.gov