search
Back to results

Parturient Controlled Epidural Analgesia (PCEA) With or Without a Basal Infusion for Early Labor

Primary Purpose

Labor Pain

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
No Basal Infusion
Basal infusion
PCEA solution (bupivacaine and fentanyl)
Sponsored by
Neil Roy Connelly, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring PCEA, labor and delivery, pain, epidural, anesthesia, pregnant women

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • The study population will consist of 100 adult obstetrical patients greater than 36 weeks gestation who request labor analgesia.

Exclusion Criteria:

  • Patients greater than 5 cm cervical dilation,
  • Patients who have received intravenous opioid agonists,
  • Patients with a contraindication to fentanyl, OR
  • Patients with pre-eclampsia are also excluded.

Sites / Locations

  • Baystate Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

No Basal Infusion

Basal Infusion

Arm Description

PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml Group 1: Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout)

PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml Group 2: Basal Infusion: 10 ml/hr; Bolus 5 ml q 30min prn (5ml demand dose with 30min lockout)

Outcomes

Primary Outcome Measures

Analgesic duration

Secondary Outcome Measures

Full Information

First Posted
March 27, 2009
Last Updated
November 17, 2015
Sponsor
Neil Roy Connelly, MD
search

1. Study Identification

Unique Protocol Identification Number
NCT00871442
Brief Title
Parturient Controlled Epidural Analgesia (PCEA) With or Without a Basal Infusion for Early Labor
Official Title
Parturient Controlled Epidural Analgesia (PCEA) With or Without a Basal Infusion for Early Labor
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Withdrawn
Why Stopped
would not substantially add to existing contributions in the literature
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Neil Roy Connelly, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patient Controlled Epidural Analgesia is a widely used and effective means of adult pain management. However, Parturient Controlled Epidural Analgesia (PCEA) is a relatively new approach to pain control for the women in labor. With the recent acquisition of new PCEA technology at Baystate Medical Center it is now possible to make this patient controlled technology available on the Labor and Delivery unit. This study is designed to determine whether there is a difference in analgesia, side effects, or analgesic duration in patients who receive a bupivacaine and fentanyl PCEA for management of labor pain. The present study hypothesizes that an analgesic protocol that includes a basal infusion rate in addition to a bolus dose controlled by the patient will have a longer analgesic duration than a pump protocol that does not have a basal infusion added to a bolus dose controlled by the patient. Methods:The study population will consist of 100 adult obstetrical patients greater than 36 weeks gestation who request labor analgesia. Patients greater than 5 cm cervical dilation, patients who have received intravenous opioid agonists, or patients with a contraindication to fentanyl will be excluded. Patients with pre-eclampsia are also excluded. One of the following PCEA treatment protocols will be started in a randomized, double blind fashion.PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml Group 1: Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout) Group 2: Basal Infusion: 10 ml/h; Bolus 5 ml q 30min prn (5ml demand dose with 30min lockout) If the patient does not obtain relief within 30 minutes, the epidural catheter will be dosed with a local anesthetic and the study will be concluded. The patients without pain relief within 30 minutes are considered to have failed epidurals and are dropped from the study and the analysis. Following achievement of satisfactory analgesia, the patient will be evaluated every 30 minutes until they request additional analgesics. The study will "end" at this point, and the patient will be treated at the discretion of the anesthesiologist.
Detailed Description
Patient Controlled Epidural Analgesia is a widely used and effective means of adult pain management. However, Parturient Controlled Epidural Analgesia (PCEA) is a relatively new approach to pain control for the women in labor. With the recent acquisition of new PCEA technology at Baystate Medical Center it is now possible to make this patient controlled technology available on the Labor and Delivery unit. Several studies have been conducted to evaluate the effects of Parturient Controlled Epidural Analgesia on different outcomes ranging from the dose of local anesthetic used, incidence of motor block, quality of analgesia, obstetric and safety outcomes, and number of patients who received anesthetic interventions. We have previously shown that epidural fentanyl (given in a 10 ml volume) is a useful means of achieving analgesia in laboring patients receiving epidural analgesia. Furthermore, we have shown that adding a bupivacaine and fentanyl infusion increases the analgesic period. This increased analgesic duration was achieved without any clinically detectable motor block. This study is designed to determine whether there is a difference in analgesia, side effects, or analgesic duration in patients who receive a bupivacaine and fentanyl PCEA for management of labor pain. The present study hypothesizes that an analgesic protocol that includes a basal infusion rate in addition to a bolus dose controlled by the patient will have a longer analgesic duration than a pump protocol that does not have a basal infusion added to a bolus dose controlled by the patient. Methods: The study population will consist of 100 adult obstetrical patients greater than 36 weeks gestation who request labor analgesia. Patients greater than 5 cm cervical dilation, patients who have received intravenous opioid agonists, or patients with a contraindication to fentanyl will be excluded. Patients with pre-eclampsia are also excluded. The screening process occurs when the patient requests labor analgesia. The study is then explained to the patient as well as the option of receiving labor analgesia without participating in the study protocol. The epidural catheters will be placed in the usual fashion in the L2-3 interspace. The catheter will be injected with 3ml lidocaine 1.5% with epinephrine 1:200,000 "test dose" (as is the usual practice at Baystate following insertion of all epidural catheters) to rule out placement of an intravenous catheter. All catheters will be placed in 5 cm. Following customary test dosing, patients will be given Fentanyl 100 mcg in 10 ml volume. After the woman is comfortable from the epidural, we will again approach the patient. If the patient then agrees to participate in the study and signs the consent form, study procedures are initiated. One of the following PCEA treatment protocols will be started in a randomized, double blind fashion. A random number table for 60 patients is generated in Excel using the Randbetween function. This function randomly generates 60 numbers either 1 or 2. When a series is generated that contains 30 1's and 30 2's, this series is selected as the random code for the study. A patient is assigned to group 1 or 2 based on the next available number. This patients name is then entered next to this number on the rand code table. PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml Group 1: Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout) Group 2: Basal Infusion: 10 ml/h; Bolus 5 ml q 30min prn (5ml demand dose with 30min lockout) The pump will be programmed by one investigator while evaluations will be done by another investigator who is unaware of the PCEA protocol. If the patient does not obtain relief within 30 minutes, the epidural catheter will be dosed with a local anesthetic and the study will be concluded. The patients without pain relief within 30 minutes are considered to have failed epidurals and are dropped from the study and the analysis. Following achievement of satisfactory analgesia, the patient will be evaluated every 30 minutes until they request additional analgesics. The study will "end" at this point, and the patient will be treated at the discretion of the anesthesiologist. Method of delivery, need for instrumented delivery, time of delivery, and neonatal APGAR scores will be recorded. The level of discomfort, presence of side effects (motor block, sedation, pruritis, and hypotension) will be evaluated at baseline, 10, 20, 30 minutes and every 30 minutes thereafter. Pain will be evaluated using a 100-mm visual analogue scale (VAS) with 0 representing no pain and 100 representing the worst possible pain. We will track several PCEA parameters including volumes infused till study termination, Bolus Demands, Bolus Deliveries, time to first bolus etc. All other aspects of the patients' care will conform to usual standards.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
PCEA, labor and delivery, pain, epidural, anesthesia, pregnant women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Basal Infusion
Arm Type
Active Comparator
Arm Description
PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml Group 1: Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout)
Arm Title
Basal Infusion
Arm Type
Active Comparator
Arm Description
PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml Group 2: Basal Infusion: 10 ml/hr; Bolus 5 ml q 30min prn (5ml demand dose with 30min lockout)
Intervention Type
Other
Intervention Name(s)
No Basal Infusion
Other Intervention Name(s)
epidural infusion, bupivicaine, patient controlled epidural anesthesia (PCEA), PCEA pump settings
Intervention Description
Group 1: Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout)
Intervention Type
Other
Intervention Name(s)
Basal infusion
Other Intervention Name(s)
epidural infusion, bupivicaine, patient controlled epidural anesthesia (PCEA), PCEA pump settings
Intervention Description
Group 2 Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout)
Intervention Type
Drug
Intervention Name(s)
PCEA solution (bupivacaine and fentanyl)
Intervention Description
PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml
Primary Outcome Measure Information:
Title
Analgesic duration
Time Frame
request for analgesia

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The study population will consist of 100 adult obstetrical patients greater than 36 weeks gestation who request labor analgesia. Exclusion Criteria: Patients greater than 5 cm cervical dilation, Patients who have received intravenous opioid agonists, Patients with a contraindication to fentanyl, OR Patients with pre-eclampsia are also excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Roy Connelly, MD
Organizational Affiliation
Baystate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Parturient Controlled Epidural Analgesia (PCEA) With or Without a Basal Infusion for Early Labor

We'll reach out to this number within 24 hrs