Neuraxial labor analgesia is performed by the administration of a local anesthetic/opioid mixture in the epidural space. The delivery method is a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia \[PCEA\]) via epidural catheter. The anesthetic solution administered through the lumbar epidural catheter must spread cephalad in the epidural space to reach the T10 nerve roots and spinal cord, and must spread caudad to reach the caudal nerve roots in the epidural space. Epidural infusion pumps capable of delivering PIEB of local anesthetic with PCEA have become commercially available and many studies have attempted to assess the optimal parameter settings (including volume of programmed bolus, bolus interval, rate of bolus administration) to provide superior labor analgesia. Traditionally higher concentration local anesthetic solutions have been associated with increased motor blockade leading to a higher incidence of instrumental vaginal delivery. Several local anesthetic solutions with varying drug concentrations are available for labor analgesia and are used clinically in the United States. We plan to perform a randomized, controlled, double-blind study to test the hypothesis that patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of a higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will require less supplemental analgesia (manual provider re-doses) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower density local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL). The aim of this study is to evaluate the association between bolus volume and concentration of local anesthetic during maintenance of labor analgesia with programmed intermittent epidural bolus (PIEB) analgesia. The hypothesis of this study is: patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will have a longer duration of adequate analgesia (time to first manual re-dose request) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower concentration local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
146
Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
Prentice Women's Hospital
Chicago, Illinois, United States
Anesthesia Provider Administered Bolus
Anesthesia provider (MD) administered boluses of additional anesthetic administered prior to the delivery of the baby.
Time frame: 72 hours
VAS at 10 Centimeters Dilation of Cervix
VAS (visual analogue scale) at 10 centimeters dilation of cervix on a scale of 0 (no pain,good) to 100 (worst pain imaginable,bad)
Time frame: 24 hours
VAS Score After Delivery
VAS score (Visual Analogue Scale) on a score of 0 (no pain,good) to 100 (worst pain imaginable,bad) immediately after delivery of baby
Time frame: 24 hours
Intrascapular Pain
Number of participants who experienced intrascapular pain (pain in your shoulder blade) during the study period.
Time frame: 72 hours
Provider Administered Bolus
Number of participants requiring anesthesia provider administration of additional bolus doses of pain medication.
Time frame: 72 hours
Number of Participants Who Required Additional Provider Redoses
Additional number of participants who required additional anesthesia care provider redoses of pain medication.
Time frame: 72 hours
Time to First Anesthesiology Provider Bolus
Time elapsed in minutes from epidural set up to time to request supplemental analgesia provided by the anesthesiology care provider.
Time frame: 72 hours
VAS Score Prior to First Provider Bolus Dose
Patient reported visual analogue scale score (0 no pain,good-100 worst pain imaginable, bad) prior to the first anesthesiology care provider bolus dose of anesthetic (pain medication).
Time frame: 72 hours
VAS Score 30 Minutes After Anesthetic Care Provider Dose
Patient reported visual analogue scale score (0 no pain, good -100 worst pain imaginable, bad) 30 minutes after the first anesthesiology care provider bolus dose of anesthetic was administered to the participant for pain relief.
Time frame: 72 hours
Bupivacaine Consumption Per Hour
Average consumption of bupivacaine in milligrams per hour.
Time frame: 72 hours
Maximum Oxytocin Dose
Maximum oxytocin dose administered intravenously in international units.
Time frame: 72 hours
Time of Intrathecal Administration to Delivery
Elapsed time in minutes from the intrathecal administration of anesthetic by anesthesiology provider to time of delivery of baby.
Time frame: 72 hours
Number of Participants Categorized by Mode of Delivery
Mode of delivery identified as: normal vaginal delivery, instrumental vaginal delivery, cesarean delivery or emergency cesarean delivery
Time frame: 72 hours
PCA Boluses
Number of Patient-Controlled Epidural Analgesia (PCEA) boluses of pain medication requested and number of PCEA medication boluses administered.
Time frame: 72 hours
PCA Boluses Ratio
The ratio of the number of Patient-Controlled Epidural Analgesia (PCEA) pain medication boluses requested and number of PCEA pain medication boluses administered by the PCEA pump.
Time frame: 72 hours
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