Clinical trial NCT05009771: Postoperative Pain Management of Caesarean Section
Official title: Postoperative Pain Management of Caesarean Section: a Prospective, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Pain
Caesarean Section
Analgesia
Keywords: Postoperative Pain
Caesarean section
Postpartum rehabilitation
Dinalbuphine sebacate
PCA
NALDEBAIN
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant woman scheduled to have caesarean section within 30 days.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 20 to 40.
2. Planing to undergo caesarean section with spinal anesthesia.
3. Scheduled to undergo cesarean section between 37 and 40 weeks of gestation.
4. American Society of Anesthesiology Physical Class 1-2.
5. Planing to alleviate postoperative pain with intravenous patient-controlled analgesia or administration of NALDEBAIN.

Exclusion Criteria:

1. Not willing to provide informed consent.
2. Unable to receive opioids or NSAIDs due to contraindication.
3. Long-term use of opioids or drug abuse.
4. Suffering from chronic pain disease.
5. Having medical history of mental illnesses.
6. Diagnosed with Pre-eclampsia or eclampsia.
7. Diagnosed with gestational diabetes.
8. Unsuitable for participation judged by investigator.

Primary outcomes:
measure: Postpartum pain intensity
timeFrame: Within 5 days after delivery
Secondary outcomes:
measure: Consumption of analgesics
timeFrame: Within 5 days after delivery
measure: Incidence of complications
timeFrame: Up to 5 days after delivery
measure: Ambulation
timeFrame: Up to 5 days after delivery
measure: Breastfeeding
timeFrame: Up to 5 days after delivery
measure: Gastrointestinal function recovery
timeFrame: Up to 5 days after delivery
measure: Postnatal Depression assessment
timeFrame: At baseline, 6 weeks and 3 months after delivery
measure: Satisfaction assessed by a four-point scale
timeFrame: 6 weeks after delivery
measure: Chronic pain intensity
timeFrame: 6 weeks and 3 months after delivery
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: MacKay Memorial Hospital Tamsui Branch
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
Study officials:
affiliation: MacKay Memorial Hospital Tamsui Branch
name: Chi-Hsu Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: