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Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?

Does the Addition of Epinephrine Increase the Duration of Intrathecal Hyperbaric Bupivacaine for Repeat Cesarean Section?

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02369510
Enrollment
68
Registered
2015-02-24
Start date
2015-02-28
Completion date
2016-05-31
Last updated
2017-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Spinal Anesthesia

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

DRUGLow-dose epinephrine

0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications

DRUGHigh-dose epinephrine

0.2ml of 1:1000 epinephrine will be added to the standard spinal medications

DRUGNo epinephrine

0.2ml of preservative-free saline will be added to the standard spinal medications

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Sensory Recoveryup to 3 hoursTime to T10 sensory recovery as measured by pinprick sensation

Secondary

MeasureTime frameDescription
Block Onsetup to 15 minTime to a onset of T4 level of anesthesia or the highest level achieved in 15min
Number of Participants With Hypotensionat 2 minutes and at 25 minutesIncidence of hypotension as measured by participants needing vasopressor agents
Adequacy of Anesthesiaup to 3 hrsAs 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 Recoveryup to 4 hoursTime to Bromage 3 motor recovery
Incidence of Nausea and Vomitingup to 3 hours
Incidence of Pruritusup to 3 hoursdata not collected
Patient Satisfactionup to 3 hoursPatient 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

ArmCount
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
Total68

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyEpidural Activation115
Overall StudySpilled Medication121

Baseline characteristics

CharacteristicLow-dose EpinephrineHigh-dose EpinephrineNo EpinephrineTotal
Age, Continuous35 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 Participants22 Participants23 Participants68 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 190 / 17
other
Total, other adverse events
0 / 210 / 190 / 17
serious
Total, serious adverse events
0 / 210 / 190 / 17

Outcome results

Primary

Sensory Recovery

Time to T10 sensory recovery as measured by pinprick sensation

Time frame: up to 3 hours

ArmMeasureValue (MEDIAN)
Low-dose EpinephrineSensory Recovery135 minutes
High-dose EpinephrineSensory Recovery165 minutes
No EpinephrineSensory Recovery120 minutes
Secondary

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

ArmMeasureValue (MEDIAN)
Low-dose EpinephrineAdequacy of Anesthesia0 units on a scale
High-dose EpinephrineAdequacy of Anesthesia0 units on a scale
No EpinephrineAdequacy of Anesthesia0 units on a scale
Secondary

Block Onset

Time to a onset of T4 level of anesthesia or the highest level achieved in 15min

Time frame: up to 15 min

ArmMeasureValue (MEDIAN)
Low-dose EpinephrineBlock Onset6 minutes
High-dose EpinephrineBlock Onset8 minutes
No EpinephrineBlock Onset8 minutes
Secondary

Incidence of Nausea and Vomiting

Time frame: up to 3 hours

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Low-dose EpinephrineIncidence of Nausea and Vomiting2 minutes2 Participants
Low-dose EpinephrineIncidence of Nausea and Vomiting25 minutes3 Participants
High-dose EpinephrineIncidence of Nausea and Vomiting2 minutes0 Participants
High-dose EpinephrineIncidence of Nausea and Vomiting25 minutes6 Participants
No EpinephrineIncidence of Nausea and Vomiting2 minutes4 Participants
No EpinephrineIncidence of Nausea and Vomiting25 minutes1 Participants
Secondary

Incidence of Pruritus

data not collected

Time frame: up to 3 hours

Secondary

Motor Recovery

Time to Bromage 3 motor recovery

Time frame: up to 4 hours

ArmMeasureValue (MEDIAN)
Low-dose EpinephrineMotor Recovery150 minutes
High-dose EpinephrineMotor Recovery172 minutes
No EpinephrineMotor Recovery120 minutes
Secondary

Number of Participants With Hypotension

Incidence of hypotension as measured by participants needing vasopressor agents

Time frame: at 2 minutes and at 25 minutes

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Low-dose EpinephrineNumber of Participants With Hypotension2 minutes5 Participants
Low-dose EpinephrineNumber of Participants With Hypotension25 minutes3 Participants
High-dose EpinephrineNumber of Participants With Hypotension2 minutes2 Participants
High-dose EpinephrineNumber of Participants With Hypotension25 minutes9 Participants
No EpinephrineNumber of Participants With Hypotension2 minutes8 Participants
No EpinephrineNumber of Participants With Hypotension25 minutes3 Participants
Secondary

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

ArmMeasureValue (NUMBER)
Low-dose EpinephrinePatient Satisfaction90 percentage of participants
High-dose EpinephrinePatient Satisfaction85 percentage of participants
No EpinephrinePatient Satisfaction87 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026