Clinical trial NCT03553576: Drug Concentration and Volume on Adequate Labor Analgesia With PIEB
Official title: The Relationship Between Local Anesthetic Concentration and Volume on Adequate Labor Analgesia With Programmed Intermittent Epidural Bolus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Anesthesia
Labor Pain
Keywords: Labor pain
Epidural
Obstetric
Labor Analgesia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 18 years and above
* Nulliparous parturients
* Present to the labor and delivery unit for an induction of labor or who are in spontaneous labor
* Request neuraxial labor analgesia at ≤5 cm cervical dilation

Exclusion Criteria:

* Patients who are not eligible to receive a combined spinal epidural (CSE) technique with 25 mcg of intrathecal fentanyl
* Non-English speaking
* Failed initiation of CSE analgesia (VAS pain score \>10 15 minutes after intrathecal dose)
* Need to have the epidural catheter replaced during labor
* Who deliver within 90 minutes of initiation of labor analgesia
* Require re-dose within 90 minutes of initiation of labor analgesia.

Primary outcomes:
measure: Anesthesia Provider Administered Bolus
timeFrame: 72 hours
Secondary outcomes:
measure: VAS at 10 Centimeters Dilation of Cervix
timeFrame: 24 hours
measure: VAS Score After Delivery
timeFrame: 24 hours
measure: Intrascapular Pain
timeFrame: 72 hours
measure: Provider Administered Bolus
timeFrame: 72 hours
measure: Number of Participants Who Required Additional Provider Redoses
timeFrame: 72 hours
measure: Time to First Anesthesiology Provider Bolus
timeFrame: 72 hours
measure: VAS Score Prior to First Provider Bolus Dose
timeFrame: 72 hours
measure: VAS Score 30 Minutes After Anesthetic Care Provider Dose
timeFrame: 72 hours
measure: Bupivacaine Consumption Per Hour
timeFrame: 72 hours
measure: Maximum Oxytocin Dose
timeFrame: 72 hours
measure: Time of Intrathecal Administration to Delivery
timeFrame: 72 hours
measure: Number of Participants Categorized by Mode of Delivery
timeFrame: 72 hours
measure: PCA Boluses
timeFrame: 72 hours
measure: PCA Boluses Ratio
timeFrame: 72 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Feyce Peralta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a.
citation: Lim Y, Sia AT, Ocampo C. Automated regular boluses for epidural analgesia: a comparison with continuous infusion. Int J Obstet Anesth. 2005 Oct;14(4):305-9. doi: 10.1016/j.ijoa.2005.05.004.
citation: 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.
citation: Kaynar AM, Shankar KB. Epidural infusion: continuous or bolus? Anesth Analg. 1999 Aug;89(2):534. doi: 10.1097/00000539-199908000-00063. No abstract available.
citation: 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.
citation: Comparative Obstetric Mobile Epidural Trial (COMET) Study Group UK. Effect of low-dose mobile versus traditional epidural techniques on mode of delivery: a randomised controlled trial. Lancet. 2001 Jul 7;358(9275):19-23. doi: 10.1016/S0140-6736(00)05251-X.