Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03195309
Other study ID # KMUHIRB-F(1)-20160019
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received April 18, 2017
Last updated June 21, 2017
Start date January 20, 2017
Est. completion date June 2019

Study information

Verified date April 2017
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date June 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Kaohsiung Medical University Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 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.
Primary 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 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 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.
See also
  Status Clinical Trial Phase
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03631329 - Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Active, not recruiting NCT03760718 - Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery Early Phase 1
Active, not recruiting NCT04965779 - The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Cesarean Delivery Women N/A
Terminated NCT01687972 - INSORB Versus Subcuticular Sutures at Cesarean Section Phase 1
Withdrawn NCT01211431 - Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine Phase 4
Completed NCT00991627 - Different Approaches to Maternal Hypotension During Cesarean Section Phase 4
Completed NCT00987701 - Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors N/A
Completed NCT01049477 - The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery N/A
Terminated NCT00524511 - Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples N/A
Terminated NCT00386477 - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial N/A
Completed NCT00375986 - A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section N/A
Completed NCT00517140 - Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function N/A
Terminated NCT05051150 - Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section Phase 4
Terminated NCT03695172 - Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section Phase 4
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Completed NCT06012747 - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Not yet recruiting NCT05187520 - Naldebain for Control of Post-Cesarean Section Pain Phase 2
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A