Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl

Pain Clinical Trial

Official title:

Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808327
• Other study ID #: 08-03
• Status: Completed
• Phase: N/A
• First received: December 11, 2008
• Last updated: November 19, 2009
• Start date: January 2009
• Est. completion date: August 2009

Study information

• Verified date: November 2009
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Bupivacaine
A single, 15mg, intrathecal dose of bupivacaine.
• Bupivacaine, fentanyl
A single, 12 mg, intrathecal dose of bupivacaine, plus 15 micrograms of fentanyl

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery.		1 hour	No
Secondary	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	No
Secondary	The degree of patient discomfort will be evaluated using a 10 cm linear visual analog scale (VAS).		1 hour	No
Secondary	The amount of additional IV analgesia administered during the intraoperative period.		1 hour	No
Secondary	Time to regression of block (minutes)		4 hours	No
Secondary	Duration of analgesia (hours)		24 hours	No
Secondary	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	No
Secondary	Dose of vasopressor(s) given during surgery		1 hour	No
Secondary	Lowest Mean Arterial Pressure during surgery (=2/3 diastolic pressure + 1/3 systolic pressure).		1 hour	No
Secondary	Patient satisfaction. A number of questions answered on a Likert Scale will be asked post-Cesarean section.		15 minutes	No
Secondary	Neonatal arterial blood gas results (pH) and 1 and 5-minute APGAR scores (1 - 10) will be recorded		10 minutes	No