Postoperative Pain
Conditions
Brief summary
The purpose of this multicenter study is to evaluate the effectiveness and safety of dexmedetomidine combined with sufentanil for patient-controlled analgesia after caesarean section
Interventions
DRUGNormal saline
Control Group receives normal saline bolus after delivery
DRUGDexmedetomidine
Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery
DRUGSufentanil
sufentanil PCA after surgery
DRUGSufentanil and dexmedetomidine
sufentanil combined with dexmedetomidine PCA after surgery
Sponsors
Obstetrics & Gynecology Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Parturients undergoing elective caesarean delivery under spinal anaesthesia 2. American Society of Anesthesiologists class I and II parturients aged 18-45 years, with term singleton pregnancies 3. Parturients with the ability to understand verbal and written mandarin 4. Parturients who want to use PCA intravenous analgesia and can use the pump correctly 5. Parturients whose written informed consent have been obtained
Exclusion criteria
1. A history of allergy to dexmedetomidine or other study drugs 2. A long use history of opioid analgesic, NSAIDs, tranquilliser use 3. Psychiatric disorders 4. A history of neuromuscular and endocrine disease or allergic disease 5. A history of lower abdominal surgery 6. Preoperative heart rate (HR) less than 50 bpm, SBP less than 100 mmHg or cardiac conduction or rhythm abnormalities 7. spinal anaesthesia was unsuccessful or an epidural catheter had to be used to achieve adequate anaesthesia 8. A second operation is required during the study. 9. Participating other study during the latest three months 10. Body mass index more than 30 kg/m2 11. Difficult airway ( Mallampati score more than 3 and anatomic deformity ) 12. Not suitable for participation estimated by investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sufentanil consumption | During 24h after surgery | The total consumption of sufentanil during 24h after surgery are recorded. |
| Changes in pain score | At 0, 4, 8 and 24 h after surgery | Pain scores at rest and movement are evaluated with a visual analogue scale (VAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Press times of analgesic pump | During 24h after surgery | The total press times and invalid press times are recorded during 24h after surgery. |
| Changes in heart rate (HR) | At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery | HR is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery. |
| Changes in Ramsay sedation score (RSS) | At 4, 8 and 24 h after surgery | Sedation intensity measured with RSS is recorded at the 4, 8 and 24 h after surgery. |
| Changes in diastolic blood pressure | At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery | Diastolic blood pressure is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery. |
| Changes in mean arterial blood | At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery | Mean arterial blood pressure is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery. |
| Changes in saturation of blood oxygen (SpO2) | At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery | SpO2 is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery |
| Changes in systolic blood pressure | At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery. | Systolic blood pressure is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery. |
Countries
China
Outcome results
None listed