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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonidine | Experimental | Participants will receive 30 mcg clonidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine). |
|
| Dexmedetomidine | Experimental | Participants will receive 4 mcg dexmedetomidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine). |
|
| Control | No Intervention | Participants will receive standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug | 30 mcg Clonidine will be given by intrathecal administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| during cesarean surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-6, 6-12, 12-24, 24-48 hours after surgery |
| Length of motor and sensory block |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical reading on PMD-200 | 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:
| 1-2 hours (intraoperatve) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard M Smiley, MD, PhD | Contact | 914-584-9531 | rms7@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ruth Landau, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center/NewYork Presbyterian Hospital | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | New York Times, Podcast, The Retrievals, Season 2, episodes 1-4. | ||
| 41221837 | 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. | |
| 41265256 |
| Label | URL |
|---|---|
| Statement on Pain During Cesarean Delivery. American Society of Anesthesiologists. | View source |
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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.
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Upon request
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| Dexmedetomidine |
| Drug |
4 mcg Dexmedetomidine will be given by intrathecal administration |
|
|
How long form spinal injection to regaining ability to bend knees and feel sensation in lumbar area |
| 2-5 hours |
| Incidence of Hypotension | 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 | Total phenylephrine infusion given over first 20 minutes after spinal (or until delivery). | 20 minutes |
| PACU side-effects/events | Events in the post-anesthesia care unit:
| 2-3 hours postop |
| Blood pressure | 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 | Any phenylephrine, ephedrine or epineprhine given other than phenylephrine infusion | From Spinal anesthesia to 20 minutes or delivery (whichever comes first) |
| Opioid use postoperatively | Milligram morphine equivalents used over 48 hours postop | 48 hours |
| Side effects | nausea/vomiting, itching | 48 hours postop |
| UA and UV blood gases | Umbilical artery and vein blood gases at birth | at delivery |
| Need for neonatal resuscitation | need for care beyond routine neonatal care | birth to 2 hours |
| Heart rate (pulse) | 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) |
| Background |
| 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. |
| 29596102 | Background | 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. |
| Statement on the Use of Adjuvant Medications and Management of Intraoperative Pain During Cesarean Delivery. American Society of Anesthesiologists. | View source |
| ID | Term |
|---|---|
| D003000 | Clonidine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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