Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl - Full Text View

Sponsor:	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Information provided by:	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:	NCT00808327

Purpose

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	Intervention
Pain	Drug: Bupivacaine Drug: Bupivacaine, fentanyl

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section Nausea and Vomiting

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:

The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
The degree of patient discomfort will be evaluated using a 10 cm linear visual analog scale (VAS). [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
The amount of additional IV analgesia administered during the intraoperative period. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Time to regression of block (minutes) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Duration of analgesia (hours) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Dose of vasopressor(s) given during surgery [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Lowest Mean Arterial Pressure during surgery (=2/3 diastolic pressure + 1/3 systolic pressure). [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Patient satisfaction. A number of questions answered on a Likert Scale will be asked post-Cesarean section. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Neonatal arterial blood gas results (pH) and 1 and 5-minute APGAR scores (1 - 10) will be recorded [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Enrollment:	140
Study Start Date:	January 2009
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	16 Years to 50 Years
Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808327

Locations

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

Sponsors and Collaborators

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Investigators

Principal Investigator:

Alison J Macarthur, MD

Mount Sinai Hospital, New York

More Information

No publications provided

Responsible Party:	Dr. Alison Macarthur, Mount Sinai Hospital
ClinicalTrials.gov Identifier:	NCT00808327 History of Changes
Other Study ID Numbers:	08-03
Study First Received:	December 11, 2008
Last Updated:	November 19, 2009
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Cesarean section
Spinal

Additional relevant MeSH terms:

Anesthetics
Bupivacaine
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local

Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012