A Comparison of Different Concentration Ropivacaine for Patient-controlled Epidural Analgesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparison of Different Concentration Ropivacaine Combination With Fentanyl for Patient-controlled Epidural Analgesia After Cesarean Delivery

Conditions
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Epidural Anesthesia, Cesarean Section

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl | Drug: Ropivacaine<br>* Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.<br>* Other names: Ropica;Drug: Fentanyl<br>* Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.<br>|
| Active Comparator: Group B<br>Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl | Drug: Ropivacaine<br>* Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.<br>* Other names: Ropica;Drug: Fentanyl<br>* Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.<br>|
| Active Comparator: Group C<br>Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl | Drug: Ropivacaine<br>* Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.<br>* Other names: Ropica;Drug: Fentanyl<br>* Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pain Scores on the numeric rating scale | The investigators use numeric rating scale(0 10) for pain severity measurement, 0 for no pain, 10 is the most severe pain | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Patient satisfaction scale | Patient satisfaction scale (1 4), 1 for very satisfied, 2 for satisfied, 3 for fair, and 4 for unsatisfied | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient-controlled Epidural Analgesia, Cesarean Delivery, Ropivacaine, Fentanyl