Programmed Intermittent Epidural Bolus Time Interval and Injection Volume

NCT00417027 | Completed Results

• 1 other identifier: 0524-027
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain

Keywords

Patient controlled epidural analgesia; Labor analgesia; Epidural analgesia

Outcome Measures

Primary Outcomes (1)

• Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia.

  Total bupivacaine from epidural solution administered for labor analgesia normalized per hour of labor.

  From initiation of labor analgesia until delivery less than 24 hours

Secondary Outcomes (6)

• Area Under the Visual Analog Pain Scores (0 to 100mm) Per Hour of Labor Analgesia Curve

  Duration of labor analgesia

• Patient Controlled Bolus Attempts

  Duration of labor analgesia

• Number of Patient Controlled Bolus Doses of Bupivacaine/Fentanyl Administered

  Duration of labor analgesia

• Manual Bolus Doses Administered

  Duration of labor analgesia

• Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.

  3 hours after initiation of labor analgesia

Study Arms (3)

2.5 mL bolused every 15 minutes

ACTIVE COMPARATOR

Procedure: Programmed Intermittent Epidural Bolus (PIEB)

5ml bolused every 30 minutes

ACTIVE COMPARATOR

Procedure: Programmed Intermittent Epidural Bolus (PIEB)

10ml bolused every 60 minutes

ACTIVE COMPARATOR

Procedure: Programmed Intermittent Epidural Bolus (PIEB)

Interventions

Programmed Intermittent Epidural Bolus (PIEB) PROCEDURE

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.

Also known as: Hospira Gemstar infusion pump

10ml bolused every 60 minutes; 2.5 mL bolused every 15 minutes; 5ml bolused every 30 minutes

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (17)

• 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. doi: 10.1177/0310057X9502300408.

  PMID: 7485937 BACKGROUND

• 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. doi: 10.1016/s0959-289x(99)80103-4.

  PMID: 15321117 BACKGROUND

• 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. doi: 10.1093/bja/59.3.325.

  PMID: 3828182 BACKGROUND

• 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. doi: 10.1007/BF03010616.

  PMID: 3289768 BACKGROUND

• 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. doi: 10.1093/bja/aef217.

  PMID: 12402726 BACKGROUND

• Paech MJ. Patient-controlled epidural analgesia in labour--is a continuous infusion of benefit? Anaesth Intensive Care. 1992 Feb;20(1):15-20. doi: 10.1177/0310057X9202000103.

  PMID: 1609935 BACKGROUND

• 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. doi: 10.1213/00000539-199407000-00015.

  PMID: 8010458 BACKGROUND

• 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. doi: 10.1097/00000542-200404000-00030.

  PMID: 15087635 BACKGROUND

• 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.

  PMID: 11129615 BACKGROUND

• 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. doi: 10.1111/j.0001-5172.2004.00413.x.

  PMID: 15196106 BACKGROUND

• 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. doi: 10.1007/BF03018402.

  PMID: 15197122 BACKGROUND

• 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. doi: 10.1097/00000542-200507000-00019.

  PMID: 15983464 BACKGROUND

• Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):150-6. doi: 10.1053/rapm.2002.29748.

  PMID: 11915061 BACKGROUND

• 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.

  PMID: 3285732 BACKGROUND

• 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. doi: 10.1093/bja/57.3.264.

  PMID: 3978008 BACKGROUND

• 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. doi: 10.1097/00000539-200002000-00017.

  PMID: 10648316 BACKGROUND

• 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. doi: 10.1007/BF03037032.

  PMID: 8467542 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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

• Title: Robert J. McCarthy, PharmD
• Organization: Northwestern University Feinberg School of Medicine

r-mccarthy@northwestern.edu

312-926-9015

Study Officials

• Cynthia A Wong, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: August 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 14, 2014
• Results First Posted: December 9, 2011

Record last verified: 2014-03

Locations

US (1)