A Comparison of Different Concentration Ropivacaine Combination With Fentanyl for Patient-controlled Epidural Analgesia After Cesarean Delivery
Overview
- Phase
- Phase 1
- Intervention
- Ropivacaine
- Conditions
- Epidural Anesthesia
- Sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Pain Scores on the numeric rating scale
- Last Updated
- 8 years ago
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
1. Written informed consent must be obtained before any study specific procedures are undertaken. 2. 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.
Investigators
Eligibility Criteria
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
Group A
Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl
Intervention: Fentanyl
Group B
Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl
Intervention: Ropivacaine
Group B
Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl
Intervention: Fentanyl
Group C
Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl
Intervention: Ropivacaine
Group C
Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl
Intervention: Fentanyl
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.)