NCT Number: NCT07567495
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 opening soon.
Get Notified18 year and older
Female
Interventional
Phase 4
New York, 10032, United States
Richard M Smiley, MD, PhD
CONTACT
Richard M Smiley, MD, PhD
SUB_INVESTIGATOR
Ruth Landau, MD
CONTACT
206-605-4527
Ruth Landau, MD
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30 mcg Clonidine will be given by intrathecal administration
4 mcg Dexmedetomidine will be given by intrathecal administration
Other names: Precedex
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:
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.
Time frame: 2-5 hours
How long form spinal injection to regaining ability to bend knees and feel sensation in lumbar area
Time frame: first 20 minutes after spinal, or until delivery
Time frame: 20 minutes
Total phenylephrine infusion given over first 20 minutes after spinal (or until delivery).
Time frame: 2-3 hours postop
Events in the post-anesthesia care unit:
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)
Time frame: From Spinal anesthesia to 20 minutes or delivery (whichever comes first)
Any phenylephrine, ephedrine or epineprhine given other than phenylephrine infusion
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:
Time frame: 48 hours
Milligram morphine equivalents used over 48 hours postop
Time frame: 48 hours postop
nausea/vomiting, itching
Time frame: at delivery
Umbilical artery and vein blood gases at birth
Time frame: birth to 2 hours
need for care beyond routine neonatal care
Time frame: Spinal injection to 20 min later or delivery (~20 min)
Contact information is provided by the study sponsor or research team.
Columbia University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07244757
Cesarean Delivery, Ketorolac
Cairo, Egypt
View Trial DetailsNCT07374133
Agnosia, Cesarean Delivery
Giresun, Turkey (Türkiye)
View Trial DetailsNCT07322419
Cesarean Delivery, Spinal Anesthesia for Cesarean Section
Al Mansurah, Dakahlia Governorate, Egypt
View Trial DetailsNCT06613243
Cesarean Delivery, Dexmedetomidine
Beijing, Beijing Municipality, China
View Trial Details