A Phase 4 interventional study of Low-dose epinephrine and High-dose epinephrine in Spinal Anesthesia and Cesarean Section, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 4, Interventional, and Supportive care
The purpose of this study is to investigate whether the addition of a medication called epinephrine to spinal medications prolongs the duration of the anesthesia. The medication standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain medication (morphine). These medications typically last about 2 hours. The investigators want to determine if adding epinephrine to the spinal medications prolongs the anesthetic without side effects. A longer duration of anesthesia may be useful in prolonged repeat cesarean section. Epinephrine is known to prolong the action of some local anesthetics, but the investigators want to specifically study combining it with the medications the investigators use regularly for cesarean section.
You may qualify to take part in this research study because you are having a repeat cesarean section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want to determine if epinephrine will prolong the anesthetic.
Spinal anesthesia with bupivacaine is a commonly used anesthetic in the obstetric population. It is most frequently carried out as a single shot intrathecal injection. This method can be utilized for both labor analgesia and surgical anesthesia for cesarean section. One of the concerns in using a single shot spinal injection for surgical anesthesia is the duration of adequate surgical conditions. This concern is especially relevant to repeat cesarean sections, as each subsequent procedure has the potential to be more complex than the prior and, therefore, prolonged. A reliable way to prolong surgical anesthesia provided by single shot spinal injection of bupivacaine could prove invaluable in the setting of repeat cesarean section. It has been well documented that adding epinephrine to intrathecal lidocaine will increase its duration1, but the evidence for augmenting the duration of anesthesia provided by adding epinephrine to bupivacaine is much more equivocal and less robust. This is a randomized control trial investigating whether or not adding epinephrine to a standard single intrathecal injection of hyperbaric bupivacaine for repeat cesarean will prolong its duration. It will be investigated using women who are undergoing scheduled repeat cesarean section in whom neuraxial anesthesia is the appropriate primary anesthetic. The investigators will compare the onset, quality and duration of both sensory and motor components of the spinal block as well as the incidence of known side effects.
Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
100micrograms of epinephrine group
Drug: Low-dose epinephrine
200micrograms of epinephrine group
Drug: High-dose epinephrine
0.2ml saline
Drug: No epinephrine
0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
Also known as: adrenaline
0.2ml of preservative-free saline will be added to the standard spinal medications
Also known as: preservative-free saline
Sensory Recovery
Time to T10 sensory recovery as measured by pinprick sensation
Time frame: up to 3 hours
Motor Recovery
Time to Bromage 3 motor recovery
Time frame: up to 4 hours
Block Onset
Time to a onset of T4 level of anesthesia or the highest level achieved in 15min
Time frame: up to 15 min
Number of Participants With Hypotension
Incidence of hypotension as measured by participants needing vasopressor agents
Time frame: at 2 minutes and at 25 minutes
Adequacy of Anesthesia
As measured by pinprick sensation and/or patient discomfort as measured by verbal pain score on a scale of 0=no pain to 10=worst imaginable pain, obtained within 3 hours of receiving anesthesia.
Time frame: up to 3 hrs
Patient Satisfaction
Patient satisfaction score was elicited upon arrival to the recovery room on a 1-5 Likert scale. Number of participants selecting the highest score of 5 or "completely satisfied".
Time frame: up to 3 hours
Incidence of Nausea and Vomiting
Time frame: up to 3 hours
Incidence of Pruritus
data not collected
Time frame: up to 3 hours
| Milestone | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine |
|---|---|---|---|
| Started | 23 | 22 | 23 |
| Completed | 21 | 19 | 17 |
| Not completed | 2 | 3 | 6 |
| Withdrew: Spilled medication | 1 | 2 | 1 |
| Withdrew: Epidural activation | 1 | 1 | 5 |
Time to T10 sensory recovery as measured by pinprick sensation
| minutes | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine |
|---|---|---|---|
| Sensory Recovery | 135 (120 to 150) | 165 (150 to 180) | 120 (45 to 150) |
Time to Bromage 3 motor recovery
| minutes | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine |
|---|---|---|---|
| Motor Recovery | 150 (135 to 150) | 172 (150 to 210) | 120 (105 to 120) |
Time to a onset of T4 level of anesthesia or the highest level achieved in 15min
| minutes | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine |
|---|---|---|---|
| Block Onset | 6 (6 to 8) | 8 (6 to 8) | 8 (6 to 10) |
Incidence of hypotension as measured by participants needing vasopressor agents
| Participants | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine |
|---|---|---|---|
| 2 minutes | 5 | 2 | 8 |
| 25 minutes | 3 | 9 | 3 |
As measured by pinprick sensation and/or patient discomfort as measured by verbal pain score on a scale of 0=no pain to 10=worst imaginable pain, obtained within 3 hours of receiving anesthesia.
| units on a scale | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine |
|---|---|---|---|
| Adequacy of Anesthesia | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 3) |
Patient satisfaction score was elicited upon arrival to the recovery room on a 1-5 Likert scale. Number of participants selecting the highest score of 5 or "completely satisfied".
| percentage of participants | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine |
|---|---|---|---|
| Patient Satisfaction | 90 | 85 | 87 |
| Participants | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine |
|---|---|---|---|
| 2 minutes | 2 | 0 | 4 |
| 25 minutes | 3 | 6 | 1 |
data not collected
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low-dose Epinephrine | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| High-dose Epinephrine | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| No Epinephrine | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Continuous(years) | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine | Total |
|---|---|---|---|---|
| Mean | 35 ± 3.86 | 34 ± 5.19 | 34 ± 5.12 | 34 ± 4.73 |
| Sex: Female, Male(Participants) | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine | Total |
|---|---|---|---|---|
| Female | 23 | 22 | 23 | 68 |
| Male | 0 | 0 | 0 | 0 |
| Pre-op Systolic Blood Pressure (SBP)(mmHg) | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine | Total |
|---|---|---|---|---|
| Mean | 116 ± 12 | 119 ± 10 | 115 ± 11 | 117 ± 11 |
| Pre-op Diastolic Blood Pressure (DBP)(mmHg) | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine | Total |
|---|---|---|---|---|
| Mean | 70 ± 11 | 70 ± 9 | 66 ± 8 | 70 ± 10 |
| Pre-op Heart Rate (HR)(beats per minute) | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine | Total |
|---|---|---|---|---|
| Mean | 82 ± 10 | 85 ± 9 | 78 ± 10 | 82 ± 10 |
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai