Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids, Clonidine, Dexmedetomidine, Postoperative Analgesia, Spinal Anesthesia for Cesarean Section
Conditions
Keywords
cesarean, dexmedetomidine, clonidine, spinal, anesthesia, Adrenergic alpha-2 Receptor Agonists
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.
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).
Interventions
DRUGClonidine
30 mcg Clonidine will be given by intrathecal administration
DRUGDexmedetomidine
4 mcg Dexmedetomidine will be given by intrathecal administration
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative discomfort | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obstetric Quality of Recovery (ObsQoR-10) Score | 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. |
| Length of motor and sensory block | 2-5 hours | How long form spinal injection to regaining ability to bend knees and feel sensation in lumbar area |
| Incidence of Hypotension | 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 |
| Phenylephrine use | 20 minutes | Total phenylephrine infusion given over first 20 minutes after spinal (or until delivery). |
| PACU side-effects/events | 2-3 hours postop | Events in the post-anesthesia care unit: 1. Hypotension requiring treatment 2. Nausea/vomiting 3. Shivering 4. Sedation |
| Blood pressure | ~ 20 minutes from spinal injection | Systolic and diastolic blood pressure every minute from spinal injection for 20 minutes or until delivery (whichever comes first) |
| Additional vasopressor use | From Spinal anesthesia to 20 minutes or delivery (whichever comes first) | Any phenylephrine, ephedrine or epineprhine given other than phenylephrine infusion |
Countries
United States
Contacts
CONTACTRichard M Smiley, MD, PhD
PRINCIPAL_INVESTIGATORRuth Landau, MD
Columbia University
Outcome results
None listed