Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Richard M Smiley, MD, PhD
- Telefonnummer: 914-584-9531
- E-post: rms7@cumc.columbia.edu
Studiesteder
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New York
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New York, New York, Forente stater, 10032
- Columbia University Irving Medical Center/NewYork Presbyterian Hospital
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Hovedetterforsker:
- Ruth Landau, MD
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Ta kontakt med:
- Richard M Smiley, MD, PhD
- Telefonnummer: 914-584-9531
- E-post: rms7@cumc.columbia.edu
-
Ta kontakt med:
- Ruth Landau, MD
- Telefonnummer: 206-605-4527
- E-post: rl262@cumc.columbia.edu
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Underetterforsker:
- Richard M Smiley, MD, PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Clonidine
Participants will receive 30 mcg clonidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
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30 mcg Clonidine will be given by intrathecal administration
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Eksperimentell: Dexmedetomidine
Participants will receive 4 mcg dexmedetomidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
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4 mcg Dexmedetomidine will be given by intrathecal administration
Andre navn:
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Ingen inngripen: Control
Participants will receive standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of intraoperative discomfort
Tidsramme: during cesarean surgery
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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:
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during cesarean surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Obstetric Quality of Recovery (ObsQoR-10) Score
Tidsramme: 0-6, 6-12, 12-24, 24-48 hours after surgery
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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.
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0-6, 6-12, 12-24, 24-48 hours after surgery
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Length of motor and sensory block
Tidsramme: 2-5 hours
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How long form spinal injection to regaining ability to bend knees and feel sensation in lumbar area
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2-5 hours
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Incidence of Hypotension
Tidsramme: first 20 minutes after spinal, or until delivery
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1. Decrease in baseline systolic blood pressure greater than 20%, or to less than 90 mm HG
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first 20 minutes after spinal, or until delivery
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Phenylephrine use
Tidsramme: 20 minutes
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Total phenylephrine infusion given over first 20 minutes after spinal (or until delivery).
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20 minutes
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PACU side-effects/events
Tidsramme: 2-3 hours postop
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Events in the post-anesthesia care unit:
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2-3 hours postop
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Blood pressure
Tidsramme: ~ 20 minutes from spinal injection
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Systolic and diastolic blood pressure every minute from spinal injection for 20 minutes or until delivery (whichever comes first)
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~ 20 minutes from spinal injection
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Additional vasopressor use
Tidsramme: From Spinal anesthesia to 20 minutes or delivery (whichever comes first)
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Any phenylephrine, ephedrine or epineprhine given other than phenylephrine infusion
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From Spinal anesthesia to 20 minutes or delivery (whichever comes first)
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Numerical reading on PMD-200
Tidsramme: 1-2 hours (intraoperatve)
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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:
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1-2 hours (intraoperatve)
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Opioid use postoperatively
Tidsramme: 48 hours
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Milligram morphine equivalents used over 48 hours postop
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48 hours
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Side effects
Tidsramme: 48 hours postop
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nausea/vomiting, itching
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48 hours postop
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UA and UV blood gases
Tidsramme: at delivery
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Umbilical artery and vein blood gases at birth
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at delivery
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Need for neonatal resuscitation
Tidsramme: birth to 2 hours
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need for care beyond routine neonatal care
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birth to 2 hours
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Heart rate (pulse)
Tidsramme: Spinal injection to 20 min later or delivery (~20 min)
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2. Heart rate every minute from spinal injection for 20 minutes or until delivery (whichever is first)
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Spinal injection to 20 min later or delivery (~20 min)
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ruth Landau, MD, Columbia University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACYY0438
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
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