Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients

Terminated

• Conditions: LABOR PAIN

• Registration Number: NCT03566342
• Lead Sponsor: Maimonides Medical Center

Brief Summary

To test the efficacy of different recipes of epidural infusions used for providing pain relief during labor in parturients.

Detailed Description

In this prospective trial, the investigators would like to examine the efficacy of several different PCEA protocols in 250 parturients who receive CSE for labor pain. Any patient with failed epidural, delivery within 2 hours of epidural insertion, or Cesarean section will be excluded from the study. Each patient will be assigned to one of five groups (A - E), depending on the day of admission for delivery, excluding Friday and Saturday (observed religious holidays). Each group will have 50 patients.

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2018-04-06
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-20
• Last Update Submitted: 2018-06-20
• Study First Posted: 2018-06-25
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 145

Inclusion Criteria

Parturients receiving Combined Spinal epidural analgesia for labor pain relief.

Exclusion Criteria

Any patient with failed epidural, delivery within 2 hours of epidural insertion, or Cesarean section will be excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain scores	24 to 48 hours.	From each patient investigators will collect pain scores to assess the severity of labor pain, using the Visual Analog Scale (VAS) scale, 1-10. VAS score of 1 is considered minimal pain and VAS score of 10 is considered as the maximum pain.

Secondary Outcome Measures

Name	Time	Method
Number of boluses	24 to 48 hours	From each patient the investigators will obtain information on total number of boluses of the epidural medication used
Motor block	24 to 48 hours.	For each patient, the investigators will obtain information regarding degree of motor block using the Modified Bromage scale.; Modified Bromage score: 1. Complete block (unable to move feet or knees); 2. Almost complete block (able to move feet only); 3. Partial block (just able to move knees); 4. Detectable weakness of hip flexion while supine (full flexion of knees); 5. No detectable weakness of hip flexion while supine; 6. Able to perform partial knee bend
Amount of medication used	24 to 48 hours	From each patient the investigators will obtain information regarding the total amount of medications used in mls from reviewing the history on the PCEA pump.
Height of the patient	At recruitment of the patient in to the study	From each patient the investigators will obtain information on height in inches.
Weight of the patient	At recruitment of the patient in to the study	From each patient the investigators will obtain information on weight in pounds
Overall patient satisfaction	24 to 48 hours	From each patient investigators will collect satisfaction scores to assess degree of satisfaction, using the Visual Analog Scale (VAS) scale, 1-10. VAS score of 1 is considered minimal satisfaction and VAS score of 10 is considered as the maximum satisfaction.
Mode of delivery	24 to 48 hours	From each patient the investigators will obtain information regarding mode of delivery- vaginal delivery or C-Section