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Programmed Intermittent Epidural Bolus Time Interval and Injection Volume

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier:
NCT00417027
First received: December 27, 2006
Last updated: November 6, 2011
Last verified: November 2011
History of Changes
Results First Received: June 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Labor Pain
Intervention: Procedure: Programmed Intermittent Epidural Bolus (PIEB)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Nulliparous women in spontaneous labor were asked to participate shortly after admission to the Labor and Delivery Unit at Prentice Women's Hospital. Immediately following the routine preanesthetic interview, subjects were approached and informed, written consent was obtained.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
2.5 mL Bolused Every 15 Minutes Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
5ml Bolused Every 30 Minutes Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
10ml Bolused Every 60 Minutes Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.

Participant Flow:   Overall Study
    2.5 mL Bolused Every 15 Minutes     5ml Bolused Every 30 Minutes     10ml Bolused Every 60 Minutes  
STARTED     66     65     59  
COMPLETED     66     60     54  
NOT COMPLETED     0     5     5  
Protocol Violation                 0                 5                 5  



  Baseline Characteristics
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Reporting Groups
  Description
2.5 mL Bolused Every 15 Minutes Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
5ml Bolused Every 30 Minutes Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
10ml Bolused Every 60 Minutes Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
Total Total of all reporting groups

Baseline Measures
    2.5 mL Bolused Every 15 Minutes     5ml Bolused Every 30 Minutes     10ml Bolused Every 60 Minutes     Total  
Number of Participants  
[units: participants]
 		  66     65     59     190  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     66     65     59     190  
>=65 years     0     0     0     0  
Age  
[units: years]
Median ( Inter-Quartile Range ) 		  31  
  ( 28 to 33 )   		  30  
  ( 27 to 33 )   		  31  
  ( 28 to 34 )   		  31  
  ( 28 to 33 )  
Gender  
[units: participants]
 		       
Female     66     65     59     190  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
United States     66     65     59     190  



  Outcome Measures
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1.  Primary:   Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia.   [ Time Frame: From initiation of labor analgesia until delivery less than 24 hours ]
  Show Outcome Measure 1

2.  Secondary:   Area Under the Visual Analog Pain Scores (0 to 100mm) Per Hour of Labor Analgesia Curve   [ Time Frame: Duration of labor analgesia ]
  Show Outcome Measure 2

3.  Secondary:   Patient Controlled Bolus Attempts   [ Time Frame: Duration of labor analgesia ]
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4.  Secondary:   Number of Patient Controlled Bolus Doses of Bupivacaine/Fentanyl Administered   [ Time Frame: Duration of labor analgesia ]
  Show Outcome Measure 4

5.  Secondary:   Manual Bolus Doses Administered   [ Time Frame: Duration of labor analgesia ]
  Show Outcome Measure 5

6.  Secondary:   Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.   [ Time Frame: 3 hours after initiation of labor analgesia ]
  Show Outcome Measure 6

7.  Secondary:   Overall Satisfaction Scores. Higher Scores Represent Greater Satisfaction With Analgesia During Labor and Delivery.   [ Time Frame: 24 hours following labor analgesia ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No group that received a continuous infusion or PCEA without a background infusion was included. Conclusions are limited to our patient population, drug concentrations, and mode of initiation of labor analgesia.  


Results Point of Contact:  
Name/Title: Robert J. McCarthy, PharmD
Organization: Northwestern University Feinberg School of Medicine
phone: 312-926-9015
e-mail: r-mccarthy@northwestern.edu


Publications:


Responsible Party: Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier: NCT00417027     History of Changes
Other Study ID Numbers: 0524-027
Study First Received: December 27, 2006
Results First Received: June 28, 2011
Last Updated: November 6, 2011
Health Authority: United States: Institutional Review Board