Cesarean Section, Epidural Anesthesia
Conditions
Keywords
Cesarean Delivery, Ropivacaine, Fentanyl, Patient-controlled Epidural Analgesia
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.
Interventions
DRUGRopivacaine
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
DRUGFentanyl
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participant do not know which formula they are receive. Nor do the daily care providers.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Scores on the numeric rating 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. | The investigators use numeric rating scale(0\ 10) for pain severity measurement, 0 for no pain, 10 is the most severe pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Patient satisfaction scale (1\ 4), 1 for very satisfied, 2 for satisfied, 3 for fair, and 4 for unsatisfied |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in modified Bromage scale | The investigatorsmeasured 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 modified Bromage scale for motor block evaluation. Modified Bromage scale(0\ 3), 0 for no motor block. 1 for inability to raise extended leg, able to move knees and feet. 2 for inability to raise extended leg and move knee, able to move feet. 3 for complete block of motor limb |
Countries
Taiwan
Outcome results
None listed