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Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00808327
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : November 20, 2009
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Bupivacaine Drug: Bupivacaine, fentanyl Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl
Study Start Date : January 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: 1
Bupivacaine alone
Drug: Bupivacaine
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




Primary Outcome Measures :
  1. The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery. [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808327


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
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Principal Investigator: Alison J Macarthur, MD MOUNT SINAI HOSPITAL

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Responsible Party: Dr. Alison Macarthur, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00808327    
Other Study ID Numbers: 08-03
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: November 20, 2009
Last Verified: November 2009
Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Cesarean section
Spinal
Additional relevant MeSH terms:
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Fentanyl
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General