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

June 21, 2017 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl
Drug: Ropivacaine
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
Other Names:
  • Ropica
Drug: Fentanyl
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
Active Comparator: Group B
Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl
Drug: Ropivacaine
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
Other Names:
  • Ropica
Drug: Fentanyl
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
Active Comparator: Group C
Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl
Drug: Ropivacaine
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
Other Names:
  • Ropica
Drug: Fentanyl
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pain Scores on the numeric rating scale
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Patient satisfaction scale
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.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in modified Bromage scale
Time Frame: 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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Principal Investigator: Hui-Fang Huang, Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-F(1)-20160019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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