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Comparing Analgesia for Postoperative Pain Relief in Spine Surgery

NCT02968862 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 99

Last updated 2016-11-21

No results posted yet for this study

Summary

The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated post surgical hospital stay of one to three days. These patients will be randomly assigned by the BWH Investigational Drug Service to one of three different groups, each consisting of 33 patients:

• Group 1 will be patients that will receive epidural hydromorphone 0. 5mg and bupivicaine 6.25 mg for a total volume of 10 ml.

* Group 2 patients will receive hydromorphone 0.5 mg in preservative free saline for a total volume of 10ml.
* Group 3 patients will receive 10 ml of preservative free saline and this will serve as the control group.

Conditions

  • Low Back Pain

Interventions

OTHER

observational

The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated post surgical hospital stay of one to three days. These patients will be randomly assigned by the BWH Investigational Drug Service to one of three different groups, each consisting of 33 patients. This is an observational studies with subjects in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive a therapeutic intervention, but the investigator does not assign specific interventions to the subjects of the study.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-05-31
Completion
2015-05-31

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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 NCT02968862 on ClinicalTrials.gov