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

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03195309
Collaborator
(none)
120
Enrollment
1
Location
3
Arms
28.3
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Participant do not know which formula they are receive. Nor do the daily care providers.
Primary Purpose:
Treatment
Official Title:
A Comparison of Different Concentration Ropivacaine Combination With Fentanyl for Patient-controlled Epidural Analgesia After Cesarean Delivery
Actual Study Start Date :
Jan 20, 2017
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Other Outcome Measures

    1. Change From Baseline in modified Bromage scale [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaohsiung Medical University Hospital Kaohsiung Taiwan 807

    Sponsors and Collaborators

    • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT03195309
    Other Study ID Numbers:
    • KMUHIRB-F(1)-20160019
    First Posted:
    Jun 22, 2017
    Last Update Posted:
    Jun 22, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital
    Cesarean Delivery
    Ropivacaine
    Fentanyl
    Patient-controlled Epidural Analgesia
    Additional relevant MeSH terms:
    Fentanyl
    Ropivacaine

    Study Results

    No Results Posted as of Jun 22, 2017