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Local Anesthetic/Opioid Mixture

Low volume bolus for Labor Pain (CADD2 Trial)

Phase 4
Waitlist Available
Led By Paloma Toledo, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery (from 0 cm to 9 cm dilation of the cervix)
Awards & highlights

CADD2 Trial Summary

This trial is a randomized, controlled, double-blind study. One hundred parturients will be randomly allocated to receive either PIEB with low-volume bolus (6.25 mL) of a higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) or PIEB with high-volume bolus (10 mL) of lower concentration local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL). The primary outcome measure is the time to first manual re-dose request. Secondary outcome measures include the

Eligible Conditions
  • Labor Pain
  • Pain
  • Anesthesia

CADD2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery (at 10 cm dilation of cervix)
This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery (at 10 cm dilation of cervix) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Need for supplemental physician-delivered bolus of local anesthetic
Secondary outcome measures
Mode of delivery
Motor block throughout labor (0-9 cm dilation)
Motor block throughout labor (10cm dilation)
+6 more

CADD2 Trial Design

2Treatment groups
Experimental Treatment
Group I: Low volume bolusExperimental Treatment1 Intervention
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Group II: High volume bolusExperimental Treatment1 Intervention
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,577 Previous Clinical Trials
911,746 Total Patients Enrolled
8 Trials studying Labor Pain
4,327 Patients Enrolled for Labor Pain
Paloma Toledo, MDPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
253 Total Patients Enrolled
1 Trials studying Labor Pain
251 Patients Enrolled for Labor Pain
Elizabeth Lange, MDPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Labor Pain
220 Patients Enrolled for Labor Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still recruiting participants?

"Affirmative. According to clinicaltrials.gov, this study has been active since it was first published on September 1st 2020 and is actively recruiting participants as of May 6th 2022. Thus far, 400 individuals have been sought at a single medical centre."

Answered by AI

How many individuals have committed to participating in this research experiment?

"Affirmative, clinicaltrials.gov data demonstrates that this medical experiment is currently recruiting. It was initially posted on September 1st 2020 and last modified on June 5th 2022. The study hopes to recruit 400 patients from a single healthcare centre."

Answered by AI

What risks might patients face with the Low volume bolus procedure?

"Having been approved for public use, low volume bolus is thought to be highly safe and thus was rated a 3 on our team's scale."

Answered by AI
Recent research and studies
~30 spots leftby Mar 2025