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

Phase 1

• Conditions: Epidural Anesthesia; Cesarean Section
• Interventions: Drug: Ropivacaine; Drug: Fentanyl

• Registration Number: NCT03195309
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study Start: 2017-01-20
• Status Verified: 2017-04
• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-06-21
• Last Update Submitted: 2017-06-21
• Study First Posted: 2017-06-22
• Last Update Posted: 2017-06-22
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Ropivacaine	Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl
Group A	Fentanyl	Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl
Group B	Ropivacaine	Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl
Group C	Ropivacaine	Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl
Group B	Fentanyl	Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl
Group C	Fentanyl	Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan