Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects

Not Applicable

Completed

Conditions: Pregnancy

Interventions: Drug: Bupivacaine
Drug: Fentanyl

Registration Number: NCT02159807

Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief Summary: The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor floor (depending on the physician preference) but the idea is to quantify safety, efficacy and side effects for each of these doses.

Detailed Description: A combined spinal epidural (CSE), which is the investigators' customary method of providing pain relief during your labor, is the identification of the epidural space in your lower back with a needle, followed by passing a thinner and longer needle through the first needle. This second needle will enter the patient's "spinal" (intrathecal) space by passing through the dura (thin covering separating the epidural space from the spinal space). The spinal (intrathecal) space is identified by flow of spinal fluid. The dura is the envelope around the spinal cord and the intrathecal space which is filled with spinal fluid. Medication will be injected at once into the spinal space, the thinner needle removed and a fine tube (catheter) will be threaded through the first needle into the epidural space. This catheter is in the epidural space and medication can be given through this catheter later on (hence the term combined) if needed. This study is a comparison of three different dosages (1.25mg, 1.66mg and 2.5 mg) of the local anesthetic (Bupivacaine) that we frequently use in the spinal, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), and of its effects on the patient's blood pressure (risk of maternal's drop of the blood pressure with possible bad effects on the blood flow to the baby), on the patient's baby's heart rate (risk of slowing down of the baby heart rate as a consequence of decreased blood flow to the baby), and the patient's pain relief (higher dose of medications are usually more effective for maternal pain relief but have side effects that can be bad for the mother and the baby). The doses of Bupivacaine the investigator routinely use on the labor and delivery floor go from 1.25 to 2.5 mg depending on clinician preferences. These doses are considered standard of care in the literature.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 170

Inclusion Criteria

ASA (American Society of Anesthesiologists Physical status) 1-2 parturients at term requesting labor analgesia
between 37 and 42 weeks gestational age
maternal age of 18 years or greater

Exclusion Criteria

Parturients with pre-eclampsia
History of pregnancy induced hypertension
Patients in whom a spinal anesthetic is contraindicated (e.g. coagulopathy, local infection) or those in whom a CSE cannot be performed
Patients with non reassuring fetal heart rate tracings prior to placement of the CSE

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.25 mg Bupivacaine	Fentanyl	1.25mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic
1.25 mg Bupivacaine	Bupivacaine	1.25mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic
1.66 mg Bupivacaine	Bupivacaine	1.66mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic
1.66 mg Bupivacaine	Fentanyl	1.66mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic
2.5 mg Bupivacaine	Bupivacaine	2.5mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic
2.5 mg Bupivacaine	Fentanyl	2.5mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic

Primary Outcome Measures

Name	Time	Method
Maternal Blood Pressure	at 1 hour	Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension

Secondary Outcome Measures

Name	Time	Method
Mean Change in Visual Analog Scale for Pain	baseline and 60 minutes	Mean change of her pain relief from the spinal epidural 60 minutes after she received it, using a VAS, scored from 0 to 10, with higher score indicating more pain.
Fetal Heart Rate at 1 Hour	at 1 hour	Baby's heart rate recorded with the external monitor that is placed on patient's belly, for a duration of 60 minutes after the placement of the combined spinal epidural.