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Status unknownNCT03195309PCEAUpdated Jun 22, 2017

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

A Phase 1/2 interventional study of Ropivacaine and Fentanyl in Epidural Anesthesia and Cesarean Section, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Status unknown at 1 site in Taiwan. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-06-22.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.
02

Conditions studied

  • Epidural Anesthesia
  • Cesarean Section

Keywords

  • Cesarean Delivery
  • Ropivacaine
  • Fentanyl
  • Patient-controlled Epidural Analgesia
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In context

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female undergoing elective Cesarean delivery and receive patient-controlled epidural analgesia

Exclusion criteria

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Group A

    Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl

    Drug: Ropivacaine · Drug: Fentanyl

  • Active comparator
    Group B

    Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl

    Drug: Ropivacaine · Drug: Fentanyl

  • Active comparator
    Group C

    Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl

    Drug: Ropivacaine · Drug: Fentanyl

Interventions

  • DrugRopivacaine

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

    Also known as: Ropica

  • DrugFentanyl

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

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What researchers measure

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    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.

Other outcomes

  1. 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

    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.

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Study locations

1 site
  • Kaohsiung Medical University Hospital
    Kaohsiung, 807, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03195309
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Jun 22, 2017
Start date
Jan 20, 2017
Primary completion
Dec 2018 (estimated)
Completion
Jun 2019 (estimated)
Last update
Jun 22, 2017

Study contacts

Hui-Fang Huang
principal investigator · Kaohsiung Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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