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 Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Bupivacaine; Drug: Bupivacaine, 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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Bupivacaine alone	Drug: Bupivacaine; A single, 15mg, intrathecal dose of bupivacaine.; Other Names: Marcaine
Active Comparator: 2; Bupivacaine plus Fentanyl	Drug: Bupivacaine, fentanyl; A single, 12 mg, intrathecal dose of bupivacaine, plus 15 micrograms of fentanyl; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery.	1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	30 minutes
The degree of patient discomfort will be evaluated using a 10 cm linear visual analog scale (VAS).	1 hour
The amount of additional IV analgesia administered during the intraoperative period.	1 hour
Time to regression of block (minutes)	4 hours
Duration of analgesia (hours)	24 hours
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.	2 hours
Dose of vasopressor(s) given during surgery	1 hour
Lowest Mean Arterial Pressure during surgery (=2/3 diastolic pressure + 1/3 systolic pressure).	1 hour
Patient satisfaction. A number of questions answered on a Likert Scale will be asked post-Cesarean section.	15 minutes
Neonatal arterial blood gas results (pH) and 1 and 5-minute APGAR scores (1 - 10) will be recorded	10 minutes

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Investigators: Principal Investigator: Alison J Macarthur, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: December 11, 2008
• First Submitted That Met QC Criteria: December 11, 2008
• First Posted (Estimate): December 15, 2008

Study Record Updates

• Last Update Posted (Estimate): November 20, 2009
• Last Update Submitted That Met QC Criteria: November 19, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Cesarean section; Spinal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: 08-03