Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients

LABOR PAIN Clinical Trial

— PCEA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03566342
• Other study ID #: IRB #08/08/VA07
• Status: Terminated
• Start date: August 2007
• Est. completion date: July 2015

Study information

• Verified date: June 2018
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 145
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• LABOR PAIN

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	Mode of delivery	From each patient the investigators will obtain information regarding mode of delivery- vaginal delivery or C-Section	24 to 48 hours