Cesarean Section, Spinal Anesthesia
Conditions
Keywords
spinal anesthesia, epinephrine, bupivacaine, repeat cesarean
Brief summary
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.
Detailed description
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.
Interventions
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
0.2ml of preservative-free saline will be added to the standard spinal medications
Sponsors
Study design
Eligibility
Inclusion criteria
* Non-emergent repeat cesarean section * Neuraxial anesthesia as the planned primary anesthetic * Informed consent obtained * Females age 18-50
Exclusion criteria
* Emergency cesarean section * Anesthetic other than neuraxial * Allergy to local anesthetics, morphine, or epinephrine * Pre-existing sensory/motor deficit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensory Recovery | up to 3 hours | Time to T10 sensory recovery as measured by pinprick sensation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Block Onset | up to 15 min | Time to a onset of T4 level of anesthesia or the highest level achieved in 15min |
| Number of Participants With Hypotension | at 2 minutes and at 25 minutes | Incidence of hypotension as measured by participants needing vasopressor agents |
| Adequacy of Anesthesia | up to 3 hrs | 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. |
| Motor Recovery | up to 4 hours | Time to Bromage 3 motor recovery |
| Incidence of Nausea and Vomiting | up to 3 hours | — |
| Incidence of Pruritus | up to 3 hours | data not collected |
| Patient Satisfaction | up to 3 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low-dose Epinephrine 100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications | 23 |
| High-dose Epinephrine 200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications | 22 |
| No Epinephrine 0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications | 23 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Epidural Activation | 1 | 1 | 5 |
| Overall Study | Spilled Medication | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Low-dose Epinephrine | High-dose Epinephrine | No Epinephrine | Total |
|---|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 3.86 | 34 years STANDARD_DEVIATION 5.19 | 34 years STANDARD_DEVIATION 5.12 | 34 years STANDARD_DEVIATION 4.73 |
| Pre-op Diastolic Blood Pressure (DBP) | 70 mmHg STANDARD_DEVIATION 11 | 70 mmHg STANDARD_DEVIATION 9 | 66 mmHg STANDARD_DEVIATION 8 | 70 mmHg STANDARD_DEVIATION 10 |
| Pre-op Heart Rate (HR) | 82 beats per minute STANDARD_DEVIATION 10 | 85 beats per minute STANDARD_DEVIATION 9 | 78 beats per minute STANDARD_DEVIATION 10 | 82 beats per minute STANDARD_DEVIATION 10 |
| Pre-op Systolic Blood Pressure (SBP) | 116 mmHg STANDARD_DEVIATION 12 | 119 mmHg STANDARD_DEVIATION 10 | 115 mmHg STANDARD_DEVIATION 11 | 117 mmHg STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 23 Participants | 22 Participants | 23 Participants | 68 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 19 | 0 / 17 |
| other Total, other adverse events | 0 / 21 | 0 / 19 | 0 / 17 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 | 0 / 17 |
Outcome results
Sensory Recovery
Time to T10 sensory recovery as measured by pinprick sensation
Time frame: up to 3 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low-dose Epinephrine | Sensory Recovery | 135 minutes |
| High-dose Epinephrine | Sensory Recovery | 165 minutes |
| No Epinephrine | Sensory Recovery | 120 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low-dose Epinephrine | Adequacy of Anesthesia | 0 units on a scale |
| High-dose Epinephrine | Adequacy of Anesthesia | 0 units on a scale |
| No Epinephrine | Adequacy of Anesthesia | 0 units on a scale |
Block Onset
Time to a onset of T4 level of anesthesia or the highest level achieved in 15min
Time frame: up to 15 min
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low-dose Epinephrine | Block Onset | 6 minutes |
| High-dose Epinephrine | Block Onset | 8 minutes |
| No Epinephrine | Block Onset | 8 minutes |
Incidence of Nausea and Vomiting
Time frame: up to 3 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low-dose Epinephrine | Incidence of Nausea and Vomiting | 2 minutes | 2 Participants |
| Low-dose Epinephrine | Incidence of Nausea and Vomiting | 25 minutes | 3 Participants |
| High-dose Epinephrine | Incidence of Nausea and Vomiting | 2 minutes | 0 Participants |
| High-dose Epinephrine | Incidence of Nausea and Vomiting | 25 minutes | 6 Participants |
| No Epinephrine | Incidence of Nausea and Vomiting | 2 minutes | 4 Participants |
| No Epinephrine | Incidence of Nausea and Vomiting | 25 minutes | 1 Participants |
Incidence of Pruritus
data not collected
Time frame: up to 3 hours
Motor Recovery
Time to Bromage 3 motor recovery
Time frame: up to 4 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low-dose Epinephrine | Motor Recovery | 150 minutes |
| High-dose Epinephrine | Motor Recovery | 172 minutes |
| No Epinephrine | Motor Recovery | 120 minutes |
Number of Participants With Hypotension
Incidence of hypotension as measured by participants needing vasopressor agents
Time frame: at 2 minutes and at 25 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low-dose Epinephrine | Number of Participants With Hypotension | 2 minutes | 5 Participants |
| Low-dose Epinephrine | Number of Participants With Hypotension | 25 minutes | 3 Participants |
| High-dose Epinephrine | Number of Participants With Hypotension | 2 minutes | 2 Participants |
| High-dose Epinephrine | Number of Participants With Hypotension | 25 minutes | 9 Participants |
| No Epinephrine | Number of Participants With Hypotension | 2 minutes | 8 Participants |
| No Epinephrine | Number of Participants With Hypotension | 25 minutes | 3 Participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low-dose Epinephrine | Patient Satisfaction | 90 percentage of participants |
| High-dose Epinephrine | Patient Satisfaction | 85 percentage of participants |
| No Epinephrine | Patient Satisfaction | 87 percentage of participants |