Programmed Intermittent Epidural Bolus Time Interval and Injection Volume - Full Text View

Purpose

Studies suggest that administration of maintenance epidural solutions as programmed or automated intermittent boluses, rather than continuous infusions, result in lower bupivacaine consumption, decreased need for manual boluses by the anesthesiologist, and greater patient satisfaction. In this technique, the epidural maintenance dose is administered as a bolus by the infusion pump at regular intervals instead of as a continuous infusion. However, the optimal combination of bolus volume and dosing interval has not been determined. At one end of the spectrum, a small volume and short bolus dose interval will likely behave like a continuous infusion. At the other end of the spectrum, a large volume and long bolus dose interval may lead to an increased incidence of breakthrough pain. The purpose of this randomized, double-blind trial was to determine how manipulation of the programmed intermittent time interval and volume influences total drug use, quality of analgesia, and patient satisfaction during maintenance of labor analgesia. We hypothesized that manipulation of the programmed intermittent bolus time interval and volume during the maintenance of epidural labor analgesia influences total drug use, quality of analgesia and patient satisfaction.

Condition	Intervention
Labor Pain	Procedure: Programmed Intermittent Epidural Bolus (PIEB)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Manipulation of the Programmed Intermittent Bolus Time Interval and Injection Volume on Total Drug Use for Labor Epidural Analgesia: a Randomized Controlled Trial

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia. [ Time Frame: From initiation of labor analgesia until delivery less than 24 hours ] [ Designated as safety issue: No ]
Total bupivacaine from epidural solution administered for labor analgesia normalized per hour of labor.

Secondary Outcome Measures:

Area Under the Visual Analog Pain Scores (0 to 100mm) Per Hour of Labor Analgesia Curve [ Time Frame: Duration of labor analgesia ] [ Designated as safety issue: No ]
The pain burden calculated as the area under the visual analog pain scale (0 to 100 mm) patient self reported assessment of pain. Pain assessment were made at regular intervals during labor and the area under the pain score per time curve was calculated as the pain burden during labor. Greater pain would be indicated by a larger area. Possible range would be 0 for no pain to 100 for severe pain.
Patient Controlled Bolus Attempts [ Time Frame: Duration of labor analgesia ] [ Designated as safety issue: No ]
The number of attempted self administered bolus doses of epidural analgesia solution for control of pain.
Number of Patient Controlled Bolus Doses of Bupivacaine/Fentanyl Administered [ Time Frame: Duration of labor analgesia ] [ Designated as safety issue: No ]
Patient controlled bolus of analgesic solution could be requested by activating a button. Bolus were 5ml of the epidural solution (bupivacaine 6.25mg/ml and fentanyl 1.96mgml). Patient requested administrations were allowed every 10 minutes to a maximum of 30 ml of epidural solution per hour.
Manual Bolus Doses Administered [ Time Frame: Duration of labor analgesia ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Highest level of sensory loss to ice 3 hours after initiation of epidural analgesia. Thoracic dermatomes specify the level at which the nerves exit the spinal column. Higher thoracic spread of analgesia suggests greater dispersion of the epidural solution and may correlate with better analgesia. Higher levels are given by lower thoracic vertebral number. For example dermatome 4 has greater spread than dermatome 5.
Overall Satisfaction Scores. Higher Scores Represent Greater Satisfaction With Analgesia During Labor and Delivery. [ Time Frame: 24 hours following labor analgesia ] [ Designated as safety issue: No ]
Patient satisfaction with analgesia management during labor and delivery. Scores are 0 to 100 with 0 complete dissatisfaction and 100 complete satisfaction with labor analgesia.

Enrollment:	190
Study Start Date:	August 2006
Study Completion Date:	April 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 2.5 mL bolused every 15 minutes	Procedure: Programmed Intermittent Epidural Bolus (PIEB) A commercial pump that can be programmed to administer intermittent boluses and patient controlled boluses does not exist. Two pumps were prepared for each subject with the same epidural solution. One pump was programmed to administer the programmed intermittent epidural bolus(PIEB). The second pump was programmed to administer patient controlled epidural analgesia (PCEA)with a dose of 5 mL delivered with a lockout of every 10 minutes. Other Name: Hospira Gemstar infusion pump
Active Comparator: 5ml bolused every 30 minutes	Procedure: Programmed Intermittent Epidural Bolus (PIEB) A commercial pump that can be programmed to administer intermittent boluses and patient controlled boluses does not exist. Two pumps were prepared for each subject with the same epidural solution. One pump was programmed to administer the programmed intermittent epidural bolus(PIEB). The second pump was programmed to administer patient controlled epidural analgesia (PCEA)with a dose of 5 mL delivered with a lockout of every 10 minutes. Other Name: Hospira Gemstar infusion pump
Active Comparator: 10ml bolused every 60 minutes	Procedure: Programmed Intermittent Epidural Bolus (PIEB) A commercial pump that can be programmed to administer intermittent boluses and patient controlled boluses does not exist. Two pumps were prepared for each subject with the same epidural solution. One pump was programmed to administer the programmed intermittent epidural bolus(PIEB). The second pump was programmed to administer patient controlled epidural analgesia (PCEA)with a dose of 5 mL delivered with a lockout of every 10 minutes. Other Name: Hospira Gemstar infusion pump

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy
nulliparous women
term gestation (greater than or equal to 37 weeks gestation)
spontaneous labor or with spontaneous rupture of membranes

Exclusion Criteria:

Systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia)
use of chronic analgesic medications
systemic opioid labor analgesia prior to the initiation of neuraxial labor analgesia
cervical dilation less than 2cm or greater than 5cm at time of initiation of neuraxial analgesia
delivery within 90 minutes of intrathecal injection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417027

Locations

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Cynthia A Wong, M.D.

Northwestern University

More Information

Publications:

Paech MJ, Pavy TJ, Sims C, Westmore MD, Storey JM, White C. Clinical experience with patient-controlled and staff-administered intermittent bolus epidural analgesia in labour. Anaesth Intensive Care. 1995 Aug;23(4):459-63.

Boutros A, Blary S, Bronchard R, Bonnet F. Comparison of intermittent epidural bolus, continuous epidural infusion and patient controlled-epidural analgesia during labor. Int J Obstet Anesth. 1999 Oct;8(4):236-41.

Bogod DG, Rosen M, Rees GA. Extradural infusion of 0.125% bupivacaine at 10 ml h-1 to women during labour. Br J Anaesth. 1987 Mar;59(3):325-30.

Smedstad KG, Morison DH. A comparative study of continuous and intermittent epidural analgesia for labour and delivery. Can J Anaesth. 1988 May;35(3 ( Pt 1)):234-41.

van der Vyver M, Halpern S, Joseph G. Patient-controlled epidural analgesia versus continuous infusion for labour analgesia: a meta-analysis. Br J Anaesth. 2002 Sep;89(3):459-65. Review.

Paech MJ. Patient-controlled epidural analgesia in labour--is a continuous infusion of benefit? Anaesth Intensive Care. 1992 Feb;20(1):15-20.

Ferrante FM, Rosinia FA, Gordon C, Datta S. The role of continuous background infusions in patient-controlled epidural analgesia for labor and delivery. Anesth Analg. 1994 Jul;79(1):80-4.

Boselli E, Debon R, Cimino Y, Rimmele T, Allaouchiche B, Chassard D. Background infusion is not beneficial during labor patient-controlled analgesia with 0.1% ropivacaine plus 0.5 microg/ml sufentanil. Anesthesiology. 2004 Apr;100(4):968-72.

Petry J, Vercauteren M, Van Mol I, Van Houwe P, Adriaensen HA. Epidural PCA with bupivacaine 0.125%, sufentanil 0.75 microgram and epinephrine 1/800.000 for labor analgesia: is a background infusion beneficial? Acta Anaesthesiol Belg. 2000;51(3):163-6.

Halonen P, Sarvela J, Saisto T, Soikkeli A, Halmesmaki E, Korttila K. Patient-controlled epidural technique improves analgesia for labor but increases cesarean delivery rate compared with the intermittent bolus technique. Acta Anaesthesiol Scand. 2004 Jul;48(6):732-7.

Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5.

Ueda K, Ueda W, Manabe M. A comparative study of sequential epidural bolus technique and continuous epidural infusion. Anesthesiology. 2005 Jul;103(1):126-9.

Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):150-6.

Chestnut DH, Owen CL, Bates JN, Ostman LG, Choi WW, Geiger MW. Continuous infusion epidural analgesia during labor: a randomized, double-blind comparison of 0.0625% bupivacaine/0.0002% fentanyl versus 0.125% bupivacaine. Anesthesiology. 1988 May;68(5):754-9.

Li DF, Rees GA, Rosen M. Continuous extradural infusion of 0.0625% or 0.125% bupivacaine for pain relief in primigravid labour. Br J Anaesth. 1985 Mar;57(3):264-70.

Bernard JM, Le Roux D, Vizquel L, Barthe A, Gonnet JM, Aldebert A, Benani RM, Fossat C, Frouin J. Patient-controlled epidural analgesia during labor: the effects of the increase in bolus and lockout interval. Anesth Analg. 2000 Feb;90(2):328-32.

Gambling DR, Huber CJ, Berkowitz J, Howell P, Swenerton JE, Ross PL, Crochetiere CT, Pavy TJ. Patient-controlled epidural analgesia in labour: varying bolus dose and lockout interval. Can J Anaesth. 1993 Mar;40(3):211-7.

Responsible Party:	Cynthia Wong, Professor of Anesthesiology, 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

Keywords provided by Northwestern University:

Patient controlled epidural analgesia
Labor analgesia
Epidural analgesia

Additional relevant MeSH terms:

Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013