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

NCT03195309 | Unknown Phase 1 DMC

• 1 other identifier: KMUHIRB-F(1)-20160019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidural Anesthesia; Cesarean Section

Keywords

Cesarean Delivery; Ropivacaine; Fentanyl; Patient-controlled Epidural Analgesia

Outcome Measures

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

  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

  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 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.

Study Arms (3)

Group A

ACTIVE COMPARATOR

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

Drug: Ropivacaine; Drug: Fentanyl

Group B

ACTIVE COMPARATOR

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

Drug: Ropivacaine; Drug: Fentanyl

Group C

ACTIVE COMPARATOR

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

Drug: Ropivacaine; Drug: Fentanyl

Interventions

Ropivacaine DRUG

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

Also known as: Ropica

Group A; Group B; Group C

Fentanyl DRUG

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

Group A; Group B; Group C

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Only include pregnant female receiving elective Cesarean delivery and post-operative epidural analgesia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• With the comorbidity of chronic heart, lung, liver and renal disease, chronic alcoholism, allergy to ropivacaine, poor epidural function and combine other anesthesia method

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Interventions

Ropivacaine; Fentanyl

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hui-Fang Huang

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participant do not know which formula they are receive. Nor do the daily care providers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: April 18, 2017
• First Posted: June 22, 2017
• Study Start: January 20, 2017
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: June 22, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)