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The Effects of Height and Weight Adjusted Dose of Local Anesthetic.

Primary Purpose

Complications; Cesarean Section, Hypotension

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Phenylephrine
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complications; Cesarean Section

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

ASA I and II patients aged 18-40 > 37 weeks gestation

  • Scheduled for an elective c-section under spinal anesthetic
  • Singleton pregnancy
  • Patients height between 150-180cm and with a BMI of <35
  • Subject understands the study and consents to participate

Exclusion Criteria:

Contraindication to neuraxial blockade

  • Local anesthetic allergy
  • Above or below our defined height and BMI criteria
  • Emergency C-Section
  • Complicated pregnancy including severe toxemia, pregnancy induced hypertension, and placenta previa

Sites / Locations

  • Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adjusted Spinal Dose

Standard Spinal Dose

Arm Description

Patients in this group receive height and weight adjusted dose for spinal anesthesia.During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. Episodes of hypotension will be treated with these vasopressors .

Patients in this group receive a fixed standard dose for spinal anesthesia. During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. Episodes of hypotension will be treated with these vasopressors .

Outcomes

Primary Outcome Measures

Maternal hypotension needing vasopressors.

Secondary Outcome Measures

Time to adequate surgical anesthetic block
incidence of nausea, vomiting, pruritus, and respiratory depression
conversion to general anesthesia due to block failure

Full Information

First Posted
December 10, 2015
Last Updated
September 23, 2022
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02635555
Brief Title
The Effects of Height and Weight Adjusted Dose of Local Anesthetic.
Official Title
The Effects of Height and Weight Adjusted Dose of Local Anesthetic Compared to Standard Dose for Spinal Anesthesia in Elective Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
At our centre a conventional dose of 12 mg of hyperbaric bupivacaine in combination with a short acting opioid fentanyl (to increase block density) and a long acting opioid morphine (to provide post-operative pain relief ) is used for spinal anesthesia for cesarean section.However, larger doses of local anesthetic drug when used in caesarean section commonly cause low blood pressure and requires drugs (vasopressors) to treat it. In our study the investigators will standardize the doses of both opioids (fentanyl/morphine) and adjust the dose of local anesthetic (bupivacaine) based on the patients height and weight .One of the obvious challenges anesthesiologists face is providing adequate anesthesia to the patient whilst minimizing harmful side effects. Our primary concern is the low blood pressure as an effect of the spinal anesthetic as it is harmful to both mother and the baby. The investigators propose that the extent of surgical anesthetic block, which is dependent on height and weight in our adjusted dose group, will provide adequate anesthesia for surgery and minimise maternal low blood pressure.
Detailed Description
Study design is prospective, randomized, double blind, placebo controlled. Patients presenting for elective cesarean section under neuraxial block and meeting inclusion criteria will be randomized to two groups: Group 1: Fixed dose group: Bupivacaine 12 mg, Fentanyl 15 mcg, Morphine 100 mcg Group 2: Height and weight adjusted bupivacaine dose, fentanyl 15 mcg, morphine 100 mcg Patients are fasted as per Canadian guidelines prior to the procedure. All patients have an IV cannula inserted,baseline vitals recorded and routine blood work checked prior to blockade. Routine monitoring (as per Canadian Anesthesia Society (CAS) guidelines) occur during and after the procedure. This includes pulse oximetry (SpO2), ECG and non-invasive blood pressure (NIBP). NIBP monitoring occurs every two minutes for the first 20 minutes post spinal and every 5 minutes thereafter. Oxygen via Hudson mask or nasal prongs is available if required. Spinal anesthetic is performed with standard doses of drugs and the level of sensory block is tested with ice. Motor block is tested with Bromage scale just before prepping and draping. Once deemed adequate, surgery begins. During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. After surgery, patients are monitored in a recovery area until fit to be transferred to their rooms. If patient reports extreme discomfort or sharp pain during the surgery,conversion to general anesthetic is as per the discretion of the attending anesthesiologist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Cesarean Section, Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjusted Spinal Dose
Arm Type
Experimental
Arm Description
Patients in this group receive height and weight adjusted dose for spinal anesthesia.During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. Episodes of hypotension will be treated with these vasopressors .
Arm Title
Standard Spinal Dose
Arm Type
Active Comparator
Arm Description
Patients in this group receive a fixed standard dose for spinal anesthesia. During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. Episodes of hypotension will be treated with these vasopressors .
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Ephedrine
Intervention Description
100 mcg of phenylephrine or 5 mg ephedrine given as deemed necessary for treating episodes of hypotension.
Primary Outcome Measure Information:
Title
Maternal hypotension needing vasopressors.
Time Frame
Until the end of surgery
Secondary Outcome Measure Information:
Title
Time to adequate surgical anesthetic block
Time Frame
24 hours after the surgery
Title
incidence of nausea, vomiting, pruritus, and respiratory depression
Time Frame
24 hours after the surgery
Title
conversion to general anesthesia due to block failure
Time Frame
1 hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I and II patients aged 18-40 > 37 weeks gestation Scheduled for an elective c-section under spinal anesthetic Singleton pregnancy Patients height between 150-180cm and with a BMI of <35 Subject understands the study and consents to participate Exclusion Criteria: Contraindication to neuraxial blockade Local anesthetic allergy Above or below our defined height and BMI criteria Emergency C-Section Complicated pregnancy including severe toxemia, pregnancy induced hypertension, and placenta previa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalini Dhir, FRCPC
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Height and Weight Adjusted Dose of Local Anesthetic.

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