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

Cesarean Section Clinical Trial

— PCEA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03195309
• Other study ID #: KMUHIRB-F(1)-20160019
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: April 18, 2017
• Last updated: June 21, 2017
• Start date: January 20, 2017
• Est. completion date: June 2019

Study information

• Verified date: April 2017
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Epidural Anesthesia

Intervention

Drug:
• Ropivacaine
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
• Fentanyl
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in modified Bromage scale	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	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.
Primary	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	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.