Spinal AnesthesiaPhase 4NCT02369510
Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?
A Phase 4 study testing Low-dose epinephrine, High-dose epinephrine and No epinephrine in people with Spinal Anesthesia and Cesarean Section, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia, Cesarean Section
- What is being tested?
- Low-dose epinephrine, High-dose epinephrine and No epinephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to May 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-emergent repeat cesarean section
- Neuraxial anesthesia as the planned primary anesthetic
- Informed consent obtained
- Females age 18-50
Who cannot join
- Emergency cesarean section
- Anesthetic other than neuraxial
- Allergy to local anesthetics, morphine, or epinephrine
- Pre-existing sensory/motor deficit
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Does the Addition of Epinephrine Increase the Duration of Intrathecal Hyperbaric Bupivacaine for Repeat Cesarean Section?
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.
Read the 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.
- Conditions
- Spinal Anesthesia, Cesarean Section
- Being tested
- Low-dose epinephrine, High-dose epinephrine, No epinephrine
- Keywords
- spinal anesthesia, epinephrine, bupivacaine, repeat cesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose epinephrineDrug
0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
High-dose epinephrineDrug
Also called adrenaline
0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
No epinephrineDrug
Also called preservative-free saline
0.2ml of preservative-free saline will be added to the standard spinal medications
| Study group | Role | What they receive |
|---|---|---|
| Low-dose epinephrine | Experimental | 100micrograms of epinephrine group Receives: Drug: Low-dose epinephrine |
| High-dose epinephrine | Experimental | 200micrograms of epinephrine group Receives: Drug: High-dose epinephrine |
| No epinephrine | Placebo comparator | 0.2ml saline Receives: Drug: No epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Recovery
Time to T10 sensory recovery as measured by pinprick sensation
Measured: up to 3 hours
Secondary outcomes (7)
Motor Recovery
Time to Bromage 3 motor recovery
Measured: up to 4 hours
Block Onset
Time to a onset of T4 level of anesthesia or the highest level achieved in 15min
Measured: up to 15 min
Number of Participants With Hypotension
Incidence of hypotension as measured by participants needing vasopressor agents
Measured: 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.
Measured: 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".
Measured: up to 3 hours
Incidence of Nausea and Vomiting
Measured: up to 3 hours
Incidence of Pruritus
data not collected
Measured: up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Katz, Icahn School of Medicine at Mount Sinai
- Investigators
- Daniel Katz, MD, Principal investigator, Icahn School of Medicine at Mount SinaiYaakov Beilin, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369510
- Sponsor's protocol ID
- GCO 14-2058
- Status last verified
- Aug 2017
- First submitted
- 17 Feb 2015
- Last updated
- 30 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Katz D, Hamburger J, Gutman D, Wang R, Lin HM, Marotta M, Zahn J, Beilin Y. The Effect of Adding Subarachnoid Epinephrine to Hyperbaric Bupivacaine and Morphine for Repeat Cesarean Delivery: A Double-Blind Prospective Randomized Control Trial. Anesth Analg. 2018 Jul;127(1):171-178. doi: 10.1213/ANE.0000000000002542.
PubMed 29077615
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Epinephrine Increase the Duration of Intrathecal Hyperbaric Bupivacaine for Repeat Cesarean Section?
- ClinicalTrials.gov ID
- NCT02369510
- Acronym / sponsor ID
- GCO 14-2058
- Conditions
- Spinal Anesthesia, Cesarean Section
- Keywords
- spinal anesthesia, epinephrine, bupivacaine, repeat cesarean
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Posted 30 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose epinephrine | Experimental | Drug: Low-dose epinephrine100micrograms of epinephrine group |
| High-dose epinephrine | Experimental | Drug: High-dose epinephrine200micrograms of epinephrine group |
| No epinephrine | Placebo comparator | Drug: No epinephrine0.2ml saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-emergent repeat cesarean section
- Neuraxial anesthesia as the planned primary anesthetic
- Informed consent obtained
- Females age 18-50
Key exclusion criteria (4 listed)
- Emergency cesarean section
- Anesthetic other than neuraxial
- Allergy to local anesthetics, morphine, or epinephrine
- Pre-existing sensory/motor deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose epinephrine0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications | Drug | Low-dose epinephrine |
| High-dose epinephrineAlso: adrenaline0.2ml of 1:1000 epinephrine will be added to the standard spinal medications | Drug | High-dose epinephrine |
| No epinephrineAlso: preservative-free saline0.2ml of preservative-free saline will be added to the standard spinal medications | Drug | No epinephrine |
Primary outcome
Sensory Recovery
Time frame: up to 3 hours
Time to T10 sensory recovery as measured by pinprick sensation
7 secondary outcomes
Motor Recovery
Time frame: up to 4 hours
Block Onset
Time frame: up to 15 min
Number of Participants With Hypotension
Time frame: at 2 minutes and at 25 minutes
Adequacy of Anesthesia
Time frame: up to 3 hrs
Patient Satisfaction
Time frame: up to 3 hours
Incidence of Nausea and Vomiting
Time frame: up to 3 hours
Incidence of Pruritus
Time frame: up to 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29077615Katz D, Hamburger J, Gutman D, Wang R, Lin HM, Marotta M, Zahn J, Beilin Y. The Effect of Adding Subarachnoid Epinephrine to Hyperbaric Bupivacaine and Morphine for Repeat Cesarean Delivery: A Double-Blind Prospective Randomized Control Trial. Anesth Analg. 2018 Jul;127(1):171-178. doi: 10.1213/ANE.0000000000002542.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Katz, MD principal investigator
Icahn School of Medicine at Mount Sinai
Yaakov Beilin, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-dose epinephrine, High-dose epinephrine and No epinephrine in people with Spinal Anesthesia and Cesarean Section, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Recovery (time frame: up to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.