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Completed

NCT Number: NCT03626753

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nefopam 20 MG/ML

Drug

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

Other names: 2 ampoule

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

Drug

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

Other names: 2 ampoule

"Acetaminophen, (paracetamol)" 500Mg Tab

Drug

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

Other names: 2 tablets

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

Drug

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

Other names: 1 ampoule: 1g

(Piroxicam "piroxan") 20 MG Oral Tablet

Drug

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

Other names: 2 tablets

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

Drug

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

Other names: 2 ampoules

Primary outcomes

  1. 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

Secondary outcomes

  1. morphine consumption

    Time frame: 24 hours postoperative

    morphine consumption

  2. 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)

  3. postoperative complications

    Time frame: 24 hours post operative

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

Sponsors and collaborators

Lead sponsor

Centre de Maternité de Monastir

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2018
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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