About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women undergoing cesarean delivery with spinal anesthesia
Disqualifiers
Significant cardiovascular, psychiatric or respiratory disease
using opioids or with chronic pain syndrome
Multiple gestation
BMI >40 kg/m2
Trial design
Factorial
Treatments tested in this trial
Clonidine
Drug30 mcg Clonidine will be given by intrathecal administration
Dexmedetomidine
Drug4 mcg Dexmedetomidine will be given by intrathecal administration
Treatment groups
Trial outcomes
Primary outcomes
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: 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 outcomes
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.
Length of motor and sensory block
How long form spinal injection to regaining ability to bend knees and feel sensation in lumbar area
Incidence of Hypotension
1\. Decrease in baseline systolic blood pressure greater than 20%, or to less than 90 mm HG
Phenylephrine use
Total phenylephrine infusion given over first 20 minutes after spinal (or until delivery).
Other outcomes
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. Skin incision 2. Delivery 3. 10 min post delivery/uterine exteriorization 4. Uterine re-insertion into the abdomen 5. Skin closure
Opioid use postoperatively
Milligram morphine equivalents used over 48 hours postop
Side effects
nausea/vomiting, itching
UA and UV blood gases
Umbilical artery and vein blood gases at birth
Sponsors and contacts
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