Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia

NCT05487196 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY22030095
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized controlled trial is to compare the effectiveness of epidural clonidine, dexmedetomidine, or fentanyl adjuncts for labor analgesia.

Conditions

Pregnancy Related

Keywords

Pregnancy; Vaginal Delivery; Epidural Labor Analgesia

Outcome Measures

Primary Outcomes (1)

• Pain Burden, AUC (30 Minutes)

  Pain score AREA UNDER THE CURVE (AUC), which is a calculated area under curve using the trapezoidal rule, where pain scores measured from 0 (no pain) to 10 (worst imaginable pain) are on the y axis, and time is on the x axis (pain scores were measured at 5 minutes, 10 minutes,15 minutes, 30 minutes after epidural initiation for the primary outcome assessment). The scale for AUC is not 0-10 but rather is completely dependent upon the area generated under the curve created by pain scores for the first 30 minutes of epidural analgesia (primary outcome time frame): in this case, the scale is 0-250 pain units\*minute, given maximum pain score possibility of 10 and time period of 30 minutes. The units of AUC are the units of Y axis times units of X axis, in this case, pain score units \* minutes. Pain AUC was compared between Fentanyl, Clonidine and Dexmedetomidine groups.

  First 30 minutes of analgesia

Secondary Outcomes (12)

• Pain Burden, AUC (120 Minutes)

  First 120 minutes of analgesia

• Pain Scores

  15 minutes after initiation of epidural analgesia

• Pain Scores

  30 minutes after initiation of epidural analgesia

• Pain Scores

  Immediately after delivery

• Cesarean Delivery

  At the time of delivery

Study Arms (3)

Clonidine

EXPERIMENTAL

Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Clonidine 60 mcg

Drug: Clonidine; Drug: Ropivacaine

Dexmedetomidine

EXPERIMENTAL

Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Dexmedetomidine 30 mcg

Drug: Dexmedetomidine; Drug: Ropivacaine

Ropivacaine + Fentanyl

ACTIVE COMPARATOR

Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Fentanyl 100mcg

Drug: Fentanyl; Drug: Ropivacaine

Interventions

Clonidine DRUG

Clonidine belongs to the drug classification of antihypertensives

Clonidine

Dexmedetomidine DRUG

Dexmedetomidine belongs to the drug classification of sedatives

Dexmedetomidine

Fentanyl DRUG

Fentanyl belongs to the drug classification of analgesic opioid agonists and is used as the standard of care

Ropivacaine + Fentanyl

Ropivacaine DRUG

Ropivacaine belongs to the drug classification of local or regional anesthesia for surgery and is used as standard of care

Clonidine; Dexmedetomidine; Ropivacaine + Fentanyl

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women greater than 18 years of age
• American Society of Anesthesiologists (ASA) Physical Status 2 or 3
• Term pregnancy (greater than 37 gestational weeks)
• Planning epidural labor analgesia
• Singleton pregnancy
• Vertex presentation
• Planned vaginal delivery

You may not qualify if:

• Pre-eclampsia with or without severe features
• New initiation of antihypertensive agent within 24 hours prior to enrollment
• Uncontrolled systemic comorbidities \[i.e., diabetes, hepatic, renal or cardiac\]
• Known or suspected fetal abnormalities
• Allergy to study agents
• Contra-indication to neuraxial anesthesia
• Inability to communicate or participate in study procedures

Sponsors & Collaborators

• Grace Lim, MD, MS: lead

Study Sites (1)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Clonidine; Dexmedetomidine; Fentanyl; Ropivacaine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The primary limitation of this study is related to the clonidine and dexmedetomidine doses used for analgesia initiation. The doses were chosen based on what was available in existing literature and clinical experience. Another limitation is that many patients who were eligible and approached declined participation, citing lack of interest in research or primarily a desire to receive only current institutional standards for epidural labor analgesia.

Results Point of Contact

• Title: Dr. Grace Lim, MD, MSc
• Organization: UPMC Magee Women's Hospital

limkg2@upmc.edu

412-641-1778

Study Officials

• Grace Lim, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study is designed as a randomized, quadruple blinded, parallel arm, controlled, non-inferiority trial in 3 groups allocated in a 1:1:1 ratio

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: September 28, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)