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Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT02036697
First received: September 26, 2013
Last updated: November 5, 2014
Last verified: September 2013
  Purpose

We propose to study the effects on hemodynamics (blood pressure, cardiac output, and central venous pressure) of two doses of bupivacaine for spinal anesthesia during cesarean section: a higher dose of 12 mg to a lower dose of 4.5 mg. We will examine recovery times, incidence of hypotension, and compare pain control and maternal satisfaction during and after cesarean section.

We hypothesize that low dose bupivacaine spinal anesthesia will provide equivalent anesthesia for cesarean section compared to conventional dose bupivacaine, with less hypotension, faster recovery time, and enhanced maternal satisfaction. Maternal satisfaction will be assessed by self-reported pain scores, incidence of nausea and vomiting, shivering, and ability to interact with baby in the OR.


Condition Intervention
Complications; Cesarean Section
Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
Hemodynamic Instability
Personal Satisfaction
Drug: Bupivacaine 4.5
Drug: Bupivacaine 9
Drug: Morphine
Drug: Fentanyl

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Recovery room length of stay [ Time Frame: Current recovery room average length of stay is 4 hours ] [ Designated as safety issue: No ]
    The primary endpoint is the expected reduction in the Recovery Room length of stay. Based on a predicted 50-100% reduction in length of stay, alpha 0.05, power of 80%, and given an anticipated drop-out rate of 10%, a sample size of n = 20 study patients per group is required.


Secondary Outcome Measures:
  • Hemodynamics [ Time Frame: Average duration of surgery is 100 minutes ] [ Designated as safety issue: No ]
    Intraoperative management during Cesarean section, Hemodynamics (BP, HR, Cardiac Index)


Other Outcome Measures:
  • Maternal satisfaction scores [ Time Frame: Average duration of recovery room stay is 4 hours. ] [ Designated as safety issue: No ]
    Post-operative maternal satisfaction scores, every 30 minutes until the patient is discharge ready from PACU.

  • Bromage Scores [ Time Frame: Average recovery room length of stay is 4 hours ] [ Designated as safety issue: No ]
    Bromage Scores every 30 minutes until discharge from PACU.

  • Sensory Levels [ Time Frame: Average recovery room length of stay is 4 hours ] [ Designated as safety issue: No ]
    Sensory levels will be measured every 30 minutes until discharge from PACU.

  • Remifentanil PCA [ Time Frame: Intra-operatively. Average OR Time is 100 minutes. ] [ Designated as safety issue: No ]
    Total Remifentanil PCA dose will be recorded intraoperatively.


Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose Spinal

Hyperbaric bupivacaine 4.5mg with fentanyl 15mcg and preservative free morphine 150mcg.

The patient will be positioned right side down and head down 20-30 degrees for the dural puncture and then positioned supine in the left lateral tilt position after the anesthetic solution has been given. The OR table will be kept in 20-30 degrees head down for the cesarean section.

Drug: Bupivacaine 4.5
Bupivacaine hyperbaric, 4.5 mg
Drug: Morphine
morphine 150 mcg.
Drug: Fentanyl
15 mcg
Active Comparator: Control Spinal Group

Hyperbaric bupivacaine 1.2cc (9mg) with fentanyl 15mcg and preservative free morphine 150mcg.

The patient will be in the sitting position for the dural puncture and then positioned supine, in the left lateral tilt position after the anesthetic solution has been given. Once block height has been established the patient will be placed in 20-30 degrees trendelenberg for the cesarean section.

Drug: Bupivacaine 9
Bupivacaine hyperbaric, 9 mg
Drug: Morphine
morphine 150 mcg.
Drug: Fentanyl
15 mcg

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult females having elective, repeat cesarean sections who have given informed consent.

Exclusion Criteria:

  • • Contraindications to dural puncture

    • BMI >40
    • Elective C/S presenting in labour or with rupture of membranes
    • Placenta previa or accrete
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036697

Contacts
Contact: Stephen E Kowalski, M.D., FRCP 204-787-3796 sekowalski@hsc.mb.ca
Contact: Doug Maguire, M.D., FRCP 204-787-3796 zmaguire@mts.net

Locations
Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3E 0W2
Principal Investigator: Stephen E Kowalski, MD, FRCP(C)         
Sub-Investigator: Doug Maguire, MD, FRCP(C)         
Sub-Investigator: Fahd Al-Gurashi, MD, FRCP(C)         
Sub-Investigator: Duane Funk, MD, FRCP(C)         
Sub-Investigator: Marta Cenkowski, MD         
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Stephen E Kowalski, MD University of Manitoba
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02036697     History of Changes
Other Study ID Numbers: B2013060
Study First Received: September 26, 2013
Last Updated: November 5, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Cesarean section
spinal anesthesia
low dose spinal
bupivacaine
hemodynamics
blood pressure
cardiac output

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Fentanyl
Morphine
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014