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Completed

NCT Number: NCT00808327

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

A single, 15mg, intrathecal dose of bupivacaine.

Other names: Marcaine

Bupivacaine, fentanyl

Drug

A single, 12 mg, intrathecal dose of bupivacaine, plus 15 micrograms of fentanyl

Other names: Marcaine

Primary outcomes

  1. The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery.

    Time frame: 1 hour

Secondary outcomes

  1. 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

  2. The degree of patient discomfort will be evaluated using a 10 cm linear visual analog scale (VAS).

    Time frame: 1 hour

  3. The amount of additional IV analgesia administered during the intraoperative period.

    Time frame: 1 hour

  4. Time to regression of block (minutes)

    Time frame: 4 hours

  5. Duration of analgesia (hours)

    Time frame: 24 hours

  6. 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

  7. Dose of vasopressor(s) given during surgery

    Time frame: 1 hour

  8. Lowest Mean Arterial Pressure during surgery (=2/3 diastolic pressure + 1/3 systolic pressure).

    Time frame: 1 hour

  9. Patient satisfaction. A number of questions answered on a Likert Scale will be asked post-Cesarean section.

    Time frame: 15 minutes

  10. Neonatal arterial blood gas results (pH) and 1 and 5-minute APGAR scores (1 - 10) will be recorded

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 15, 2008
Registry last updated
Nov 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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