Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose epinephrine | Experimental | 100micrograms of epinephrine group |
|
| High-dose epinephrine | Experimental | 200micrograms of epinephrine group |
|
| No epinephrine | Placebo Comparator | 0.2ml saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose epinephrine | Drug | 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensory Recovery | Time to T10 sensory recovery as measured by pinprick sensation | up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Recovery | Time to Bromage 3 motor recovery | up to 4 hours |
| Block Onset | Time to a onset of T4 level of anesthesia or the highest level achieved in 15min |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Katz, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Yaakov Beilin, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29077615 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | High-dose Epinephrine | 200micrograms of epinephrine group High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications |
| FG002 | No Epinephrine | 0.2ml saline No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | High-dose Epinephrine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensory Recovery | Time to T10 sensory recovery as measured by pinprick sensation | Posted | Median | 95% Confidence Interval | minutes | up to 3 hours |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Katz | Icahn School of Medicine at Mount Sinai | 212-241-7475 | Daniel.Katz@MountSinai.org |
Not provided
| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| High-dose epinephrine | Drug | 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications |
|
|
| No epinephrine | Drug | 0.2ml of preservative-free saline will be added to the standard spinal medications |
|
|
| up to 15 min |
| Number of Participants With Hypotension | Incidence of hypotension as measured by participants needing vasopressor agents | 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. | 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". | up to 3 hours |
| Incidence of Nausea and Vomiting | up to 3 hours |
| Incidence of Pruritus | data not collected | up to 3 hours |
200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
| BG002 | No Epinephrine | 0.2ml saline No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pre-op Systolic Blood Pressure (SBP) | Mean | Standard Deviation | mmHg |
|
| Pre-op Diastolic Blood Pressure (DBP) | Mean | Standard Deviation | mmHg |
|
| Pre-op Heart Rate (HR) | Mean | Standard Deviation | beats per minute |
|
0.2ml saline No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications |
|
|
| Secondary | Motor Recovery | Time to Bromage 3 motor recovery | Posted | Median | 95% Confidence Interval | minutes | up to 4 hours |
|
|
|
| Secondary | Block Onset | Time to a onset of T4 level of anesthesia or the highest level achieved in 15min | Posted | Median | Inter-Quartile Range | minutes | up to 15 min |
|
|
|
| Secondary | Number of Participants With Hypotension | Incidence of hypotension as measured by participants needing vasopressor agents | Posted | Count of Participants | Participants | at 2 minutes and at 25 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. | Posted | Median | Inter-Quartile Range | units on a scale | up to 3 hrs |
|
|
|
| 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". | Posted | Number | percentage of participants | up to 3 hours |
|
|
|
| Secondary | Incidence of Nausea and Vomiting | Posted | Count of Participants | Participants | up to 3 hours |
|
|
|
| Secondary | Incidence of Pruritus | data not collected | Posted | up to 3 hours |
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | High-dose Epinephrine | 200micrograms of epinephrine group High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | No Epinephrine | 0.2ml saline No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications | 0 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
Not provided
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|