Pregnancy RelatedPhase 2NCT05487196
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
A Phase 2 study testing Clonidine, Dexmedetomidine and Fentanyl in people with Pregnancy Related, run by Grace Lim, MD, MS at 1 site in United States.
Trial summary
The purpose of this randomized controlled trial is to compare the effectiveness of epidural clonidine, dexmedetomidine, or fentanyl adjuncts for labor analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Clonidine, Dexmedetomidine and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2022to 31 Jul 2023
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia: A Randomized Controlled Quadruple Blinded Non-Inferiority Trial (CLASSIER Trial)
The purpose of this randomized controlled trial is to compare the effectiveness of epidural clonidine, dexmedetomidine, or fentanyl adjuncts for labor analgesia.
Read the detailed description
Adjuncts for epidural labor analgesia have remained unchanged for decades, whereas changes in patient population and the opioid epidemic have created an increased demand for non-opioid alternative adjuncts to limit peripartum opioid exposure. This study aims to identify effective alternative and non-opioid adjunctive agents for epidural labor analgesia.
The opioid crisis in the United States has translated to an increasing number of pregnant women requiring care for labor and delivery. These trends have resulted in new questions about alternative epidural analgesia adjuncts besides lipophilic opioids (e.g., fentanyl and sufentanil) because: 1) many people with opioid or substance use disorder desire to avoid opioids in all formulations and routes of administration; and 2) epidural fentanyl or sufentanil administration for labor can potentially interfere with the accuracy of urine drug screening in the postpartum period, which has implications for postpartum social services considerations.
Some existing literature suggests that dexmedetomidine and clonidine are viable adjuncts to local anesthetics that offer a faster onset and a better quality of analgesia for patients requiring labor analgesia. However, the relative effectiveness of these adjunctive agents for labor analgesia have not been compared head-to-head. Better data on how these adjuncts compare with each other for labor analgesia efficacy, can result in more informed clinical care strategies.
This trial was initially initiated as a superiority design. After further scientific input, it was decided that a non-inferiority design would be more informative for the clinical question at hand. The hypothesis is that clonidine (Group C) and dexmedetomidine (Group D) are non-inferior to fentanyl (Group F) (usual care) as adjuncts for epidural labor analgesia. The null hypothesis is that clonidine and dexmedetomidine are inferior to fentanyl as adjuncts for epidural labor analgesia. Clinical Protocol specific methodology did not change throughout the trial and the full trial protocol document can be found in the relevant section below. An updated statistical analysis plan includes updated sample size calculations and has been reported to account for the noninferiority analysis plan. No data was analyzed prior to the completion of all data collection procedures.
- Conditions
- Pregnancy Related
- Being tested
- Clonidine, Dexmedetomidine, Fentanyl, Ropivacaine
- Keywords
- Pregnancy, Vaginal Delivery, Epidural Labor Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
Clonidine belongs to the drug classification of antihypertensives
DexmedetomidineDrug
Dexmedetomidine belongs to the drug classification of sedatives
FentanylDrug
Fentanyl belongs to the drug classification of analgesic opioid agonists and is used as the standard of care
RopivacaineDrug
Ropivacaine belongs to the drug classification of local or regional anesthesia for surgery and is used as standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Fentanyl; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 30 minutes of analgesia
Secondary outcomes (12)
Pain Burden, AUC (120 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, 60 minutes, 90 minutes and 120 minutes after epidural initiation). 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 120 minutes of epidural analgesia: in this case, the scale is 0-850 pain units*minute, given maximum pain score possibility of 10 and time period of 120 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.
Measured: First 120 minutes of analgesia
Pain Scores
Pain as defined by the Numeric Rating Score (NRS) in which the minimum score of 0 indicates no pain at all and the maximum score of 10 indicates the worst pain imaginable.
Measured: 15 minutes after initiation of epidural analgesia
Pain Scores
Pain as defined by the Numeric Rating Score (NRS) in which the minimum score of 0 indicates no pain at all and the maximum score of 10 indicates the worst pain imaginable.
Measured: 30 minutes after initiation of epidural analgesia
Pain Scores
Pain as defined by the Numeric Rating Score (NRS) in which the minimum score of 0 indicates no pain at all and the maximum score of 10 indicates the worst pain imaginable.
Measured: Immediately after delivery
Cesarean Delivery
This will be measured by yes/no response to cesarean delivery mode of delivery outcome. We report the raw numbers of patients who did receive a cesarean delivery according to group.
Measured: At the time of delivery
Hypotension
This is measured as any hypotensive event occurring any time between 0-120 min after study drug administration.
Measured: Between 0-120 min after study drug administration
Nausea
Patient self-report of nausea at any time between 0-120 min after study drug administration
Measured: 0-120 min after study drug administration
Vomiting
Patient self-report of vomiting at any time between 0-120 min after study drug administration
Measured: 0-120 min after study drug administration
Shivering
Patient self-report of shivering at any time between 0-120 min after study drug administration
Measured: 0-120 min after study drug administration
Pruritus
Patient self-report of pruritus at any time between 0-120 min after study drug administration
Measured: 0-120 min after study drug administration
Patient Treatment Satisfaction
Patient self-report regarding satisfaction with analgesia on a scale of 1-10; 1 = not satisfied, 10 = the most satisfied.
Measured: Immediately after delivery
Newborn Apgar Score
The Apgar score is a method of assessing newborn health at the time of delivery. Score range 0 to 10 where 0 is poor health and 10 is the best health.
Measured: 1 minute after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start28 Sep 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Lim, MD, MS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grace Lim, MD, MS, University of Pittsburgh
- Investigators
- Grace Lim, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487196
- Sponsor's protocol ID
- STUDY22030095
- Status last verified
- Apr 2025
- First submitted
- 2 Aug 2022
- Last updated
- 27 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No