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Clinical Trials/NCT00871442
NCT00871442WithdrawnPhase 3

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

Neil Roy Connelly, MD1 site in 1 countryStarted: May 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Withdrawn
Sponsor
Locations
1
Primary Endpoint
Analgesic duration

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

No Basal Infusion

Active Comparator

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)

Intervention: No Basal Infusion (Other)

No Basal Infusion

Active Comparator

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)

Intervention: PCEA solution (bupivacaine and fentanyl) (Drug)

Basal Infusion

Active Comparator

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: Basal infusion (Other)

Basal Infusion

Active Comparator

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: PCEA solution (bupivacaine and fentanyl) (Drug)

Outcomes

Primary Outcomes

Analgesic duration

Time Frame: request for analgesia

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Neil Roy Connelly, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Neil Roy Connelly, MD

Anesthesiologist

Baystate Medical Center

Study Sites (1)

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