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Cesarean DeliveryPhase 4NCT07567495

Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery

A Phase 4 study testing Clonidine and Dexmedetomidine in people with Cesarean Delivery and Cesarean Delivery; Neuraxial Opioids, run by Columbia University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will examine whether addition of dexmedetomidine or clonidine (two alpha-2 adrenergic agonists) will improve the comfort of patients during spinal anesthesia for cesarean delivery. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Clonidine and Dexmedetomidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
14 May 2026to 15 May 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pregnant women undergoing cesarean delivery with spinal anesthesia

Who cannot join

  • Significant cardiovascular, psychiatric or respiratory disease
  • using opioids or with chronic pain syndrome
  • Multiple gestation
  • BMI >40 kg/m2
  • Quaternary or greater cesarean
  • < 37 weeks gestation
Show all 10Show fewer
  • Non-English or Spanish speaking
  • planned vertical skin incision
  • planned vertical (classical) uterine incision
  • allergy to clonidine, dexmedetomidine or other study drug

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Richard M Smiley, MD, PhD contact

914-584-9531

rms7@cumc.columbia.edu

United States1 site, 1 recruiting

  • Columbia University Irving Medical Center/NewYork Presbyterian Hospital

    New York, New York, 10032

    Richard M Smiley, MD, PhD, 914-584-9531, rms7@cumc.columbia.edu

    Ruth Landau, MD, ‭206-605-4527‬, rl262@cumc.columbia.edu

    Recruiting

Other trials in United States

About this study

This study will examine whether addition of dexmedetomidine or clonidine (two alpha-2 adrenergic agonists) will improve the comfort of patients during spinal anesthesia for cesarean delivery. When added to standard spinal anesthesia consisting of bupivacaine (a local anesthetic) and fentanyl and morphine (two opioids), these medications may decrease some of the pulling/tugging/pressure sensations that patients sometimes feel during cesarean delivery, may prolong the anesthetic time, and may decrease postoperative pain.

Read the detailed description

While spinal anesthesia almost always creates a reasonably comfortable operative/birth experience, a significant proportion of women do experience significance "pressure" or "pulling" and some do have sensations described as painful during the operation. This has received increased interest in both the medical and lay press in recent years. The main medication in a spinal anesthetic is the local anesthetic, usually bupivacaine, but a variety of adjuvants can and are used to improve the analgesia and decrease sensation (or increase the time period of effectiveness) of the anesthetic. Opioids (usually fentanyl or sufentanil for intraoperative benefits and morphine for postoperative analgesia) are very commonly added to spinal anesthetics for cesarean delivery in the United States.

Somewhat less commonly, but increasingly, alpha-2 adrenergic agonists (clonidine or dexmedetomidine), which have sedative and analgesic properties (mostly analgesic when given into spinal fluid) are added in an attempt to improve the intraoperative experience and/or lengthen the time the block is effective. These adjuvants, although not approved specifically for this use in spinal anesthesia, have become more widely used in spinal anesthesia, including for cesarean delivery, and have been mentioned/recommended in recent statements by the American Society of Anesthesiologists for use when additional or improved analgesia may be needed or desired.

The quality of the studies of intrathecal dexmedetomidine as part of spinal anesthesia for cesarean delivery is quite poor. This study will investigate whether clonidine or dexmedetomidine, when added to a spinal anesthetic containing bupivacaine/fentanyl/morphine, will improve intraoperative analgesia/anesthesia, decrease unwanted sensation, and assess what the other effects will be (prolongation of sensory and motor block, effects on blood pressure, other side effects).

Being tested
Clonidine, Dexmedetomidine
Keywords
cesarean, dexmedetomidine, clonidine, spinal, anesthesia, Adrenergic alpha-2 Receptor Agonists

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClonidineDrug

    30 mcg Clonidine will be given by intrathecal administration

  • DexmedetomidineDrug

    Also called Precedex

    4 mcg Dexmedetomidine will be given by intrathecal administration

Study groups in NCT07567495
Study groupRoleWhat they receive
ClonidineExperimentalParticipants will receive 30 mcg clonidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
Receives: Drug: Clonidine
DexmedetomidineExperimentalParticipants will receive 4 mcg dexmedetomidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
Receives: Drug: Dexmedetomidine
ControlNo interventionParticipants will receive standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of intraoperative discomfort

    The primary outcome of this study is the incidence of self-reported intraoperative discomfort, defined as pain or uncomfortable pressure, tugging, pulling feeling during cesarean delivery.

    At specific timepoints during cesarean delivery surgery, the patient will be asked "Do you feel uncomfortable sensations (pain, pressure, pulling, tugging)?" If the answer is "yes, " she will be asked "Do you want medication to treat it?"

    The timepoints specified will be:

    1. Foley (urinary) catheter placement
    2. Allis clamp test (testing for pain at incision site and umbilicus before starting surgery)
    3. Skin incision
    4. Uterine incision
    5. Delivery
    6. Uterine exteriorization
    7. Fascial closure
    8. Skin closure
    9. Manual uterine compression in OR after closure
    10. At any point other than the above that the patient complains of pain or uncomfortable sensations

    Measured: during cesarean surgery

Secondary outcomes (7)

  1. Obstetric Quality of Recovery (ObsQoR-10) Score

    Postoperative pain will be assessed by the self-reported Obstetric Quality of Recovery Score after surgery. The full scale is 0 to 10, with 0 being no pain, and 10 being the worst pain imaginable.

    Measured: 0-6, 6-12, 12-24, 24-48 hours after surgery

  2. Length of motor and sensory block

    How long form spinal injection to regaining ability to bend knees and feel sensation in lumbar area

    Measured: 2-5 hours

  3. Incidence of Hypotension

    1. Decrease in baseline systolic blood pressure greater than 20%, or to less than 90 mm HG

    Measured: first 20 minutes after spinal, or until delivery

  4. Phenylephrine use

    Total phenylephrine infusion given over first 20 minutes after spinal (or until delivery).

    Measured: 20 minutes

  5. PACU side-effects/events

    Events in the post-anesthesia care unit:

    1. Hypotension requiring treatment
    2. Nausea/vomiting
    3. Shivering
    4. Sedation

    Measured: 2-3 hours postop

  6. Blood pressure

    Systolic and diastolic blood pressure every minute from spinal injection for 20 minutes or until delivery (whichever comes first)

    Measured: ~ 20 minutes from spinal injection

  7. Additional vasopressor use

    Any phenylephrine, ephedrine or epineprhine given other than phenylephrine infusion

    Measured: From Spinal anesthesia to 20 minutes or delivery (whichever comes first)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start14 May 2026
  3. Primary completion14 May 2028 (estimated)
  4. Study completion15 May 2028 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07567495
Sponsor's protocol ID
ACYY0438
Status last verified
Oct 2026
First submitted
8 Jan 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Based on an appropriate request form qualified researchers, we are willing to share de-identified data regarding participants in spreadsheet or other appropriate form , if allowed by our local IRB.

Publications

  • New York Times, Podcast, The Retrievals, Season 2, episodes 1-4.

  • Orbach-Zinger S, Azem K, Bar M, Heesen P, Kozuch D, Furman D, Cohen R, Kashkush A, Izyumsky D, Fein S, Frenkel A, Shavialiou A, Binyamin Y. Intra-operative sensation during caesarean delivery under neuraxial anaesthesia: A prospective cohort study mapping sensory experiences. Eur J Anaesthesiol. 2026 Mar 1;43(3):217-225. doi: 10.1097/EJA.0000000000002317. Epub 2025 Nov 11.

    PubMed 41221837

  • Takalo E, Karpala M, An X, Cobb B, Zhao S, Bari R, Hylton M, Grant S, Schoenherr J. Intrathecal dexmedetomidine for cesarean delivery and postoperative outcomes: a single-center retrospective cohort study (2019-2020). Int J Obstet Anesth. 2026 Feb;65:104819. doi: 10.1016/j.ijoa.2025.104819. Epub 2025 Nov 14.

    PubMed 41265256

  • Fernandes HS, Bliacheriene F, Vago TM, Corregliano GT, Torres ML, Francisco RP, Ashmawi HA. Clonidine Effect on Pain After Cesarean Delivery: A Randomized Controlled Trial of Different Routes of Administration. Anesth Analg. 2018 Jul;127(1):165-170. doi: 10.1213/ANE.0000000000003319.

    PubMed 29596102

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clonidine and Dexmedetomidine in people with Cesarean Delivery and Cesarean Delivery; Neuraxial Opioids, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Richard M Smiley, MD, PhD (914-584-9531, rms7@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of intraoperative discomfort (time frame: during cesarean surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07567495, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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