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

Kaohsiung Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cesarean Section; Epidural Anesthesia

Treatments: Drug: Ropivacaine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03195309

KMUHIRB-F(1)-20160019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Group A

Active Comparator group

Description:

Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl

Treatment:

Drug: Ropivacaine

Drug: Fentanyl

Group B

Active Comparator group

Description:

Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl

Treatment:

Drug: Ropivacaine

Drug: Fentanyl

Group C

Active Comparator group

Description:

Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl

Treatment:

Drug: Ropivacaine

Drug: Fentanyl