Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients (PCEA)

Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients Receiving Combined Spinal and Epidural Analgesia (CSE)

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

Study Overview

• Status: Terminated
• Conditions: LABOR PAIN

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 Type: Observational
• Enrollment (Actual): 145

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Laboring women receiving combined spinal epidural analgesia for pain relief

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
GROUP A; The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 8ml Lockout ( number of doses per hour) 2 Lock out interval 30 minutes
GROUP B; The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 5ml Lockout ( number of doses per hour) 4 Lock out interval 15 minutes
GROUP C; The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 3ml Lockout ( number of doses per hour) 6 Lock out interval 10 minutes
GROUP D; The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 14 ml/hour Demand dose 0 ml Lockout ( number of doses per hour) 0 Lock out interval 0 minutes
GROUP E; The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 7ml Lockout ( number of doses per hour) 3 Lock out interval 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	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.	24 to 48 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of boluses	From each patient the investigators will obtain information on total number of boluses of the epidural medication used	24 to 48 hours
Amount of medication used	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.	24 to 48 hours
Motor block	For each patient, the investigators will obtain information regarding degree of motor block using the Modified Bromage scale. Modified Bromage score: Complete block (unable to move feet or knees); Almost complete block (able to move feet only); Partial block (just able to move knees); Detectable weakness of hip flexion while supine (full flexion of knees); No detectable weakness of hip flexion while supine; Able to perform partial knee bend	24 to 48 hours.
Height of the patient	From each patient the investigators will obtain information on height in inches.	At recruitment of the patient in to the study
Weight of the patient	From each patient the investigators will obtain information on weight in pounds	At recruitment of the patient in to the study
Overall patient satisfaction	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.	24 to 48 hours
Mode of delivery	From each patient the investigators will obtain information regarding mode of delivery- vaginal delivery or C-Section	24 to 48 hours

Collaborators and Investigators

• Sponsor: Maimonides Medical Center
• Investigators: Principal Investigator: KALPANA TYAGARAJ, MAIMONIDES MEDICAL CENTER, 4802, 10TH AVENUE, BROOKLYN, NY-11219

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: IRB #08/08/VA07