Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorColumbia University

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 volunteers

Qualifiers

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

Design model

Factorial

Treatments tested in this trial

  • Clonidine

    Drug

    30 mcg Clonidine will be given by intrathecal administration

  • Dexmedetomidine

    Drug

    4 mcg Dexmedetomidine will be given by intrathecal administration

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: ClonidineExperimental treatment 1 intervention
Group B: DexmedetomidineExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
during cesarean surgery

Secondary outcomes

1

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.

Time frame
0-6, 6-12, 12-24, 24-48 hours after surgery
2

Length of motor and sensory block

How long form spinal injection to regaining ability to bend knees and feel sensation in lumbar area

Time frame
2-5 hours
3

Incidence of Hypotension

1\. Decrease in baseline systolic blood pressure greater than 20%, or to less than 90 mm HG

Time frame
first 20 minutes after spinal, or until delivery
4

Phenylephrine use

Total phenylephrine infusion given over first 20 minutes after spinal (or until delivery).

Time frame
20 minutes

Other outcomes

1

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

Time frame
1-2 hours (intraoperatve)
2

Opioid use postoperatively

Milligram morphine equivalents used over 48 hours postop

Time frame
48 hours
3

Side effects

nausea/vomiting, itching

Time frame
48 hours postop
4

UA and UV blood gases

Umbilical artery and vein blood gases at birth

Time frame
at delivery

Sponsors and contacts

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