Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section

NCT02036697 | Terminated

• 1 other identifier: B2013060
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complications; Cesarean Section; Effects of; Anesthesia, Spinal and Epidural, in Pregnancy; Hemodynamic Instability; Personal Satisfaction

Keywords

Cesarean section; spinal anesthesia; low dose spinal; bupivacaine; hemodynamics; blood pressure; cardiac output

Outcome Measures

Primary Outcomes (1)

• Recovery room length of stay

  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.

  Current recovery room average length of stay is 4 hours

Secondary Outcomes (1)

• Hemodynamics

  Average duration of surgery is 100 minutes

Other Outcomes (4)

• Maternal satisfaction scores

  Average duration of recovery room stay is 4 hours.

• Bromage Scores

  Average recovery room length of stay is 4 hours

• Sensory Levels

  Average recovery room length of stay is 4 hours

Study Arms (2)

Low Dose Spinal

EXPERIMENTAL

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; Drug: Morphine; Drug: Fentanyl

Control Spinal Group

ACTIVE COMPARATOR

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; Drug: Morphine; Drug: Fentanyl

Interventions

Bupivacaine 4.5 DRUG

Bupivacaine hyperbaric, 4.5 mg

Low Dose Spinal

Bupivacaine 9 DRUG

Bupivacaine hyperbaric, 9 mg

Control Spinal Group

Morphine DRUG

morphine 150 mcg.

Control Spinal Group; Low Dose Spinal

Fentanyl DRUG

15 mcg

Control Spinal Group; Low Dose Spinal

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Contraindications to dural puncture
• BMI \>40
• Elective C/S presenting in labour or with rupture of membranes
• Placenta previa or accrete

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3E 0W2, Canada

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Morphine; Fentanyl

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Stephen E Kowalski, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: January 15, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 8, 2016

Record last verified: 2016-05

Locations

CA (1)