Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section
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| ClinicalTrials.gov Identifier: NCT03626753 |
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Recruitment Status :
Completed
First Posted : August 13, 2018
Last Update Posted : August 15, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cesarean Section; Complications, Wound, Infection (Following Delivery) Postoperative Pain Spinal Anaesthesia During the Puerperium | Drug: Nefopam 20 MG/ML Drug: "Nefopam (Acupan)" 20 MG/ML Injectable Solution Drug: "Acetaminophen, (paracetamol)" 500Mg Tab Drug: (Acetaminophen "paracetamol") IV Soln 10 MG/ML Drug: (Piroxicam "piroxan") 20 MG Oral Tablet Drug: (Piroxicam "piroxan") 20Mg/1mL Injection | Phase 2 Phase 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section Oral vs Intravenous |
| Actual Study Start Date : | January 1, 2015 |
| Actual Primary Completion Date : | June 30, 2015 |
| Actual Study Completion Date : | June 30, 2015 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Oral Group
received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
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Drug: Nefopam 20 MG/ML
given by Oral route the dose of 20mg every 6 hours.
Other Name: 2 ampoule Drug: "Acetaminophen, (paracetamol)" 500Mg Tab 2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.
Other Name: 2 tablets Drug: (Piroxicam "piroxan") 20 MG Oral Tablet 2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.
Other Name: 2 tablets |
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Active Comparator: Intravenous group
received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
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Drug: "Nefopam (Acupan)" 20 MG/ML Injectable Solution
given by intravenous route at the dose of 20mg every 6 hours.
Other Name: 2 ampoule Drug: (Acetaminophen "paracetamol") IV Soln 10 MG/ML Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.
Other Name: 1 ampoule: 1g Drug: (Piroxicam "piroxan") 20Mg/1mL Injection 2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.
Other Name: 2 ampoules |
- 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
- morphine consumption [ Time Frame: 24 hours postoperative ]morphine consumption
- 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)
- postoperative complications [ Time Frame: 24 hours post operative ]The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626753
| Tunisia | |
| Centre de Maternité de Monastir | |
| Monastir, Tunisia, 5000 | |
| Responsible Party: | Fethi Jebali, Medical doctor, clinical professor of Anesthesiology and intensive care medecine, Centre de Maternité de Monastir |
| ClinicalTrials.gov Identifier: | NCT03626753 |
| Other Study ID Numbers: |
CMNMonastir |
| First Posted: | August 13, 2018 Key Record Dates |
| Last Update Posted: | August 15, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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 |
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Pain multimodal analgesia postoperative cesarean section obstetric |
Agents Physiological effects of drugs opioid Paracetamol NSAIDs |
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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Acetaminophen Piroxicam Nefopam Proroxan Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Psychotropic Drugs |