NCT07567495

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
23mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

January 8, 2026

Last Update Submit

April 30, 2026

Conditions

Cesarean DeliveryCesarean Delivery; Neuraxial OpioidsSpinal Anesthesia for Cesarean SectionDexmedetomidineClonidinePostoperative Analgesia

Keywords

cesareandexmedetomidineclonidinespinalanesthesiaAdrenergic alpha-2 Receptor Agonists

Outcome Measures

Primary Outcomes (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

    during cesarean surgery

Secondary Outcomes (7)

  • Obstetric Quality of Recovery (ObsQoR-10) Score

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

  • Length of motor and sensory block

    2-5 hours

  • Incidence of Hypotension

    first 20 minutes after spinal, or until delivery

  • Phenylephrine use

    20 minutes

  • PACU side-effects/events

    2-3 hours postop

  • +2 more secondary outcomes

Other Outcomes (6)

  • Numerical reading on PMD-200

    1-2 hours (intraoperatve)

  • Opioid use postoperatively

    48 hours

  • Side effects

    48 hours postop

  • +3 more other outcomes

Study Arms (3)

Clonidine

EXPERIMENTAL

Participants will receive 30 mcg clonidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).

Drug: Clonidine

Dexmedetomidine

EXPERIMENTAL

Participants will receive 4 mcg dexmedetomidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).

Drug: Dexmedetomidine

Control

NO INTERVENTION

Participants will receive standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).

Interventions

ClonidineDRUG

30 mcg Clonidine will be given by intrathecal administration

Clonidine
DexmedetomidineDRUG

4 mcg Dexmedetomidine will be given by intrathecal administration

Also known as: Precedex
Dexmedetomidine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women undergoing cesarean delivery with spinal anesthesia

You may not qualify if:

  • 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
  • Non-English or Spanish speaking
  • planned vertical skin incision
  • planned vertical (classical) uterine incision
  • allergy to clonidine, dexmedetomidine or other study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center/NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (4)

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

    BACKGROUND

  • 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.

    PMID: 41221837BACKGROUND

  • 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.

    PMID: 41265256BACKGROUND

  • 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.

    PMID: 29596102BACKGROUND

Related Links

MeSH Terms

Interventions

ClonidineDexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ruth Landau, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard M Smiley, MD, PhD

CONTACT

914-584-9531rms7@cumc.columbia.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Virginia Apgar, M.D. Professor of Anesthesiology

Study Record Dates

First Submitted

January 8, 2026

First Posted

May 5, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Access Criteria
Upon request

Locations

US(1)