A Comparison of Different Concentration Ropivacaine Combination With Fentanyl for Patient-controlled Epidural Analgesia After Cesarean Delivery
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Pain Scores on the numeric rating scale
Study Overview
Brief Summary
To compare the postoperative analgesic effect and the intensity of motor block in different concentration ropivacaine plus fentanyl when used epidurally with a patient-controlled analgesia device after Cesarean delivery.
Detailed Description
- Written informed consent must be obtained before any study specific procedures are undertaken.
- All patients were received epidural anesthesia with 2% Lidocaine and patient-controlled epidural analgesia (PCEA) for post- operative pain control. PCEA randomly allocated into three groups. Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl, Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl, and Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl. Dermographic data, dosage of PCEA during first 48 hours post-operation，NRS scores, patient satisfaction and the intensity of motor block will be recorded and analyzed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Participant do not know which formula they are receive. Nor do the daily care providers.
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female undergoing elective Cesarean delivery and receive patient-controlled epidural analgesia
Exclusion Criteria
- •With the comorbidity of chronic heart, lung, liver and renal disease, chronic alcoholism, allergy to ropivacaine, poor epidural function and combine other anesthesia method
Arms & Interventions
Group A
Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl
Intervention: Ropivacaine (Drug)
Group A
Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl
Intervention: Fentanyl (Drug)
Group B
Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl
Intervention: Ropivacaine (Drug)
Group B
Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl
Intervention: Fentanyl (Drug)
Group C
Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl
Intervention: Ropivacaine (Drug)
Group C
Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl
Intervention: Fentanyl (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Pain Scores on the numeric rating scale
Time Frame: The investigators measured numeric score changing at 5 different timing. The first is when arrival post-operative care unit, the second is when arrival post-operative care unit for 2 hours. And then 6,24,48 hours after operation.
The investigators use numeric rating scale(0\~10) for pain severity measurement, 0 for no pain, 10 is the most severe pain
Secondary Outcomes
- Change From Baseline in Patient satisfaction scale(The investigators measured numeric score changing at 5 different timing. The first is when arrival post-operative care unit, the second is when arrival post-operative care unit for 2 hours. And then 6,24,48 hours after operation.)