Drug Concentration and Volume on Adequate Labor Analgesia With PIEB

Phase 4

Terminated

• Conditions: Pain; Anesthesia; Labor Pain
• Interventions: Drug: Low volume bolus; Drug: High volume bolus

• Registration Number: NCT03553576
• Lead Sponsor: Northwestern University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-12
• Study Start: 2020-01-21
• Primary Completion: 2023-05-31
• Study Completion: 2023-06-01
• Results First Submitted: 2024-05-06
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Results First Posted: 2025-05-21
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 146

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low volume bolus	Low volume bolus	6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
High volume bolus	High volume bolus	10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).

Primary Outcome Measures

Name	Time	Method
Anesthesia Provider Administered Bolus	72 hours	Anesthesia provider (MD) administered boluses of additional anesthetic administered prior to the delivery of the baby.

Secondary Outcome Measures

Name	Time	Method
VAS at 10 Centimeters Dilation of Cervix	24 hours	VAS (visual analogue scale) at 10 centimeters dilation of cervix on a scale of 0 (no pain,good) to 100 (worst pain imaginable,bad)
VAS Score After Delivery	24 hours	VAS score (Visual Analogue Scale) on a score of 0 (no pain,good) to 100 (worst pain imaginable,bad) immediately after delivery of baby
Intrascapular Pain	72 hours	Number of participants who experienced intrascapular pain (pain in your shoulder blade) during the study period.
Provider Administered Bolus	72 hours	Number of participants requiring anesthesia provider administration of additional bolus doses of pain medication.
Number of Participants Who Required Additional Provider Redoses	72 hours	Additional number of participants who required additional anesthesia care provider redoses of pain medication.
Time to First Anesthesiology Provider Bolus	72 hours	Time elapsed in minutes from epidural set up to time to request supplemental analgesia provided by the anesthesiology care provider.
VAS Score Prior to First Provider Bolus Dose	72 hours	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).
VAS Score 30 Minutes After Anesthetic Care Provider Dose	72 hours	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.
Bupivacaine Consumption Per Hour	72 hours	Average consumption of bupivacaine in milligrams per hour.
Maximum Oxytocin Dose	72 hours	Maximum oxytocin dose administered intravenously in international units.
Time of Intrathecal Administration to Delivery	72 hours	Elapsed time in minutes from the intrathecal administration of anesthetic by anesthesiology provider to time of delivery of baby.
Number of Participants Categorized by Mode of Delivery	72 hours	Mode of delivery identified as: normal vaginal delivery, instrumental vaginal delivery, cesarean delivery or emergency cesarean delivery
PCA Boluses	72 hours	Number of Patient-Controlled Epidural Analgesia (PCEA) boluses of pain medication requested and number of PCEA medication boluses administered.
PCA Boluses Ratio	72 hours	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.

Trial Locations

Locations (1)

Prentice Women's Hospital; 🇺🇸 Chicago, Illinois, United States