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

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ClinicalTrials.gov Identifier: NCT03195309
Recruitment Status : Unknown
Verified April 2017 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Epidural Anesthesia Cesarean Section Drug: Ropivacaine Drug: Fentanyl 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : January 20, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Ropica

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only include pregnant female receiving elective Cesarean delivery and post-operative epidural analgesia
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195309


Locations
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Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Hui-Fang Huang Kaohsiung Medical University

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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03195309     History of Changes
Other Study ID Numbers: KMUHIRB-F(1)-20160019
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Fentanyl
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local