Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl
The safest form of anesthesia for Cesarean section is a spinal anesthetic. All spinal anesthetics contain a local anesthetic and/or a narcotic. A drug named bupivacaine is the most commonly used local anesthetic in spinal anesthetics for Cesarean deliveries in North America. Another drug named fentanyl is the most commonly used narcotic. This study will look at whether a spinal anesthetic with 15mg of bupivacaine alone will be the same as a spinal anesthetic with 12mg of bupivacaine and 15ug of fentanyl.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl|
- The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- Speed of onset of block to T4 dermatome (minutes), as well as highest level of block (dermatomal level) and degree of motor block (Bromage scale) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
- The degree of patient discomfort will be evaluated using a 10 cm linear visual analog scale (VAS). [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- The amount of additional IV analgesia administered during the intraoperative period. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- Time to regression of block (minutes) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- Duration of analgesia (hours) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Incidence of side effects: Intraoperative pruritus, nausea and vomiting in the absence of hypotension, somnolence, shivering, euphoria or dysphoria and respiratory depression will be evaluated. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- Dose of vasopressor(s) given during surgery [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- Lowest Mean Arterial Pressure during surgery (=2/3 diastolic pressure + 1/3 systolic pressure). [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- Patient satisfaction. A number of questions answered on a Likert Scale will be asked post-Cesarean section. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
- Neonatal arterial blood gas results (pH) and 1 and 5-minute APGAR scores (1 - 10) will be recorded [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
A single, 15mg, intrathecal dose of bupivacaine.
Other Name: Marcaine
Active Comparator: 2
Bupivacaine plus Fentanyl
Drug: Bupivacaine, fentanyl
A single, 12 mg, intrathecal dose of bupivacaine, plus 15 micrograms of fentanyl
Other Name: Marcaine
There have been many studies looking at different doses and combinations of bupivacaine and fentanyl but there is no agreement among anesthesiologists as to the best combination of drugs.
The main problem with bupivacaine is that it causes hypotension (low blood pressure). When fentanyl is added to bupivacaine, a lower dose of bupivacaine can be used so that there is less of a fall in blood pressure. The main problem with fentanyl is itchiness and sleepiness. In the case of an emergency Cesarean section, the extra time needed to draw-up and administer a second medication may make a difference to the health of the baby.
Our goal is to determine whether high dose bupivacaine (15mg) alone will produce spinal anaesthesia for cesarean delivery equivalent to 12mg of intrathecal hyperbaric bupivacaine in combination with 15ug of intrathecal fentanyl.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808327
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G1X5|
|Principal Investigator:||Alison J Macarthur, MD||Mount Sinai Hospital, New York|