Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery

April 30, 2026 updated by: Ruth Landau-Cahana, Columbia University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center/NewYork Presbyterian Hospital
        • Principal Investigator:
          • Ruth Landau, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Richard M Smiley, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant women undergoing cesarean delivery with spinal anesthesia

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clonidine
Participants will receive 30 mcg clonidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
Drug: Clonidine
30 mcg Clonidine will be given by intrathecal administration
Experimental: Dexmedetomidine
Participants will receive 4 mcg dexmedetomidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
Drug: Dexmedetomidine
4 mcg Dexmedetomidine will be given by intrathecal administration
Other Names:
  • Precedex
No Intervention: Control
Participants will receive standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of intraoperative discomfort
Time Frame: during cesarean surgery

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obstetric Quality of Recovery (ObsQoR-10) Score
Time Frame: 0-6, 6-12, 12-24, 24-48 hours after surgery
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.
0-6, 6-12, 12-24, 24-48 hours after surgery
Length of motor and sensory block
Time Frame: 2-5 hours
How long form spinal injection to regaining ability to bend knees and feel sensation in lumbar area
2-5 hours
Incidence of Hypotension
Time Frame: first 20 minutes after spinal, or until delivery
1. Decrease in baseline systolic blood pressure greater than 20%, or to less than 90 mm HG
first 20 minutes after spinal, or until delivery
Phenylephrine use
Time Frame: 20 minutes
Total phenylephrine infusion given over first 20 minutes after spinal (or until delivery).
20 minutes
PACU side-effects/events
Time Frame: 2-3 hours postop

Events in the post-anesthesia care unit:

  1. Hypotension requiring treatment
  2. Nausea/vomiting
  3. Shivering
  4. Sedation
2-3 hours postop
Blood pressure
Time Frame: ~ 20 minutes from spinal injection
Systolic and diastolic blood pressure every minute from spinal injection for 20 minutes or until delivery (whichever comes first)
~ 20 minutes from spinal injection
Additional vasopressor use
Time Frame: From Spinal anesthesia to 20 minutes or delivery (whichever comes first)
Any phenylephrine, ephedrine or epineprhine given other than phenylephrine infusion
From Spinal anesthesia to 20 minutes or delivery (whichever comes first)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical reading on PMD-200
Time Frame: 1-2 hours (intraoperatve)

Reading on the PMD (an FDA-approved device that uses a finger probe to detect "nociception," " a measure of sensation/discomfort/pain. The readngs will be recorded at the following timepoints:

  1. Skin incision
  2. Delivery
  3. 10 min post delivery/uterine exteriorization
  4. Uterine re-insertion into the abdomen
  5. Skin closure
1-2 hours (intraoperatve)
Opioid use postoperatively
Time Frame: 48 hours
Milligram morphine equivalents used over 48 hours postop
48 hours
Side effects
Time Frame: 48 hours postop
nausea/vomiting, itching
48 hours postop
UA and UV blood gases
Time Frame: at delivery
Umbilical artery and vein blood gases at birth
at delivery
Need for neonatal resuscitation
Time Frame: birth to 2 hours
need for care beyond routine neonatal care
birth to 2 hours
Heart rate (pulse)
Time Frame: Spinal injection to 20 min later or delivery (~20 min)
2. Heart rate every minute from spinal injection for 20 minutes or until delivery (whichever is first)
Spinal injection to 20 min later or delivery (~20 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Ruth Landau, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACYY0438

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Access Criteria

Upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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