Léčba pooperační bolesti u císařského řezu
Pooperační léčba bolesti u císařského řezu: prospektivní, observační kohortová studie
Caesarean section is one of the most frequent surgeries causing severe postoperative pain. Poor management of acute pain can contribute to postoperative complications, late recovery and the development of chronic pain. Moreover, it had been demonstrated that the intensity of postpartum pain is associated with depression. It is imperative to find out appropriate methods of postpartum pain alleviation. Currently, a lot of analgesic drugs and methods have been developed and used in clinical practice, such as patient-controlled analgesia, extended-release analgesics and multimodal analgesia. This prospective cohort study is aimed to investigate the outcome of each postoperative analgesic method used in caesarean section.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This is a prospective, observational, cohort study. Patients undergoing elective caesarean section will be invited to the study. The written informed consent will be obtained prior to participation. After getting the written informed consent, data will be collected from medical records, questionnaires, patient diaries, visit records and telephone visit records. Through telephone visits, postpartum depression scale and postpartum chronic pain will be evaluated six weeks and three months after delivery. Demographic data, consumption of analgesics, analgesic methods, intensity of postoperative pain, complications, recovery time, score of depression scale will all be summarized. Numerical variables will be present with mean and standard deviation and categorical variables will be present with number and percentage.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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New Taipei City, Tchaj-wan, 251
- MacKay Memorial Hospital Tamsui Branch
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Taipei, Tchaj-wan, 104
- MacKay Memorial Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Pregnant woman scheduled to have caesarean section within 30 days.
Popis
Inclusion Criteria:
- Aged 20 to 40.
- Planing to undergo caesarean section with spinal anesthesia.
- Scheduled to undergo cesarean section between 37 and 40 weeks of gestation.
- American Society of Anesthesiology Physical Class 1-2.
- Planing to alleviate postoperative pain with intravenous patient-controlled analgesia or administration of NALDEBAIN.
Exclusion Criteria:
- Not willing to provide informed consent.
- Unable to receive opioids or NSAIDs due to contraindication.
- Long-term use of opioids or drug abuse.
- Suffering from chronic pain disease.
- Having medical history of mental illnesses.
- Diagnosed with Pre-eclampsia or eclampsia.
- Diagnosed with gestational diabetes.
- Unsuitable for participation judged by investigator.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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IV-PCA + NALDEBAIN group
Patients treated with the combination of IV-PCA and intramuscular injection of dinalbuphine sebacate will be allocated to IV-PCA + NALDEBAIN group. |
At the two trial sites, IV-PCA is commonly used with morphine. The device is installed after delivery and removed within 3 days.
Ostatní jména:
Dinalbuphine sebacate is a prodrug of nalbuphine. With oil-based formulation, the active ingredient releases slowly and the effect lasts longer than nalbuphine. After delivery, a single 150 mg dose of dinalbuphine sebacate is administered intramuscularly.
Ostatní jména:
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IV-PCA group
Patients receiving intravenous patient-controlled analgesia (IV-PCA) will be allocated to IV-PCA group. |
At the two trial sites, IV-PCA is commonly used with morphine. The device is installed after delivery and removed within 3 days.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Postpartum pain intensity
Časové okno: Within 5 days after delivery
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Pain intensity is assessed by numerical rating scale (NRS) at least twice daily during hospital stay after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain). The area under the curve of NRS are calculated. |
Within 5 days after delivery
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Consumption of analgesics
Časové okno: Within 5 days after delivery
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The mean total consumption of analgesics during the hospital stay after delivery. |
Within 5 days after delivery
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Incidence of complications
Časové okno: Up to 5 days after delivery
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the incidence of postoperative complication occurring during hospital stay after delivery, especially the ones related to analgesics. |
Up to 5 days after delivery
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Ambulation
Časové okno: Up to 5 days after delivery
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The mean length of time between delivery and the first ambulation. |
Up to 5 days after delivery
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Breastfeeding
Časové okno: Up to 5 days after delivery
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The percentage of participants able to breastfeed during hospital stay and the mean length of time between delivery and the first breastfeeding. |
Up to 5 days after delivery
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Gastrointestinal function recovery
Časové okno: Up to 5 days after delivery
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The mean length of time between delivery and first soft diet. |
Up to 5 days after delivery
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Postnatal Depression assessment
Časové okno: At baseline, 6 weeks and 3 months after delivery
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Edinburgh Postnatal Depression questionnaire is used to assess patients' postpartum depression. Participants are asked to fill in the questionnaire at baseline (within 30 days prior to delivery), 6 weeks and 3 months after delivery. |
At baseline, 6 weeks and 3 months after delivery
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Satisfaction assessed by a four-point scale
Časové okno: 6 weeks after delivery
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Participants are asked to assess the satisfaction toward rate of recovery progress and pain management through 6 questions six weeks after delivery. Each question contain 4 choices: very satisfied, satisfied, dissatisfied and very dissatisfied. |
6 weeks after delivery
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Chronic pain intensity
Časové okno: 6 weeks and 3 months after delivery
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Chronic pain intensity is assessed by NRS 6 weeks and 3 months after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain). |
6 weeks and 3 months after delivery
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Chi-Hsu Wang, M.D., MacKay Memorial Hospital Tamsui Branch
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 21MMHIS203e
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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