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Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl

S

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Completed

Conditions

Pain

Treatments

Drug: Bupivacaine, fentanyl
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

Female

Ages

16 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

140 participants in 2 patient groups

1
Active Comparator group
Description:
Bupivacaine alone
Treatment:
Drug: Bupivacaine
2
Active Comparator group
Description:
Bupivacaine plus Fentanyl
Treatment:
Drug: Bupivacaine, fentanyl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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