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

NCT02635555 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-09-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Phenylephrine

100 mcg of phenylephrine or 5 mg ephedrine given as deemed necessary for treating episodes of hypotension.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Shalini Dhir, FRCPC · Western University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-06-30
Completion
2019-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02635555 on ClinicalTrials.gov