Clinical trial NCT00808327: Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl
Official title: Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Cesarean section
Spinal
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2008-12-15
Enrollment: 140
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* healthy patients (ASA 1 or 2)
* BMI \< 40
* height between 5 \& 6 feet

Exclusion Criteria:

* parturients with pregnancy induced hypertension or preeclampsia
* parturients with significant cardiac, renal or other organ-system disease which preclude choice of spinal anesthesia
* emergency delivery
* triplet or greater multiple gestation

Primary outcomes:
measure: The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery.
timeFrame: 1 hour
Secondary outcomes:
measure: 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)
timeFrame: 30 minutes
measure: The degree of patient discomfort will be evaluated using a 10 cm linear visual analog scale (VAS).
timeFrame: 1 hour
measure: The amount of additional IV analgesia administered during the intraoperative period.
timeFrame: 1 hour
measure: Time to regression of block (minutes)
timeFrame: 4 hours
measure: Duration of analgesia (hours)
timeFrame: 24 hours
measure: 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.
timeFrame: 2 hours
measure: Dose of vasopressor(s) given during surgery
timeFrame: 1 hour
measure: Lowest Mean Arterial Pressure during surgery (=2/3 diastolic pressure + 1/3 systolic pressure).
timeFrame: 1 hour
measure: Patient satisfaction. A number of questions answered on a Likert Scale will be asked post-Cesarean section.
timeFrame: 15 minutes
measure: Neonatal arterial blood gas results (pH) and 1 and 5-minute APGAR scores (1 - 10) will be recorded
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Alison J Macarthur, MD
role: PRINCIPAL_INVESTIGATOR
References: