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

Phase 2UnknownNCT03195309

Kaohsiung Medical University Chung-Ho Memorial Hospital120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Epidural Anesthesia Cesarean Section

Interventions

RopivacaineDRUG

Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.

FentanylDRUG

Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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