Comparing Analgesia for Postoperative Pain Relief in Spine Surgery

NCT02968862 | Completed DMC

• 1 other identifier: 2010P000602
• Study Type: observational
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• low back pain

  The postoperative pain scores will be obtained and recorded by the Study Coordinator. This will be obtained by the visual analog scale (VAS) (enclosed) every 15 minutes up until 2 hours and on postoperative day one(24 hours). The type and time for the first demand for supplemental analgesia and the total amount will also be documented.

  24 hours

Interventions

observational OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All subjects will be provided information about the study at their surgical appointment. The study coordinator will approach the patient with permission from the surgeon and introduce the study and one of the co- investigators will explain the study to the patient. The investigator will review their eligibility and the inclusion criteria and the exclusion criteria. If the subject continues to meet all the criteria, the investigator will explain the study with the patient and answer all questions. Thereafter, the patients will be provided the consent forms for their review and a 24/7 contact number for any questions regarding this study.

You may qualify if:

• adult patients
• years of age or older

You may not qualify if:

• Anyone unable to sign consent
• Pregnant patients
• Non-elective surgery
• Allergy to any of the study drugs or equipment
• Any medical condition not compatible with the use of epidural anesthesia such as multiple sclerosis
• Any patient with a rash at the surgical site or for cerebrospinal leak repair
• Any patient who is currently anticoagulated for any reason (drugs or pathologic condition)
• Patient who in the opinion of the Investigator may not be a suitable candidate for this study.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (1)

• Aglio LS, Abd-El-Barr MM, Orhurhu V, Kim GY, Zhou J, Gugino LD, Crossley LJ, Gosnell JL, Chi JH, Groff MW. Preemptive analgesia for postoperative pain relief in thoracolumbosacral spine operations: a double-blind, placebo-controlled randomized trial. J Neurosurg Spine. 2018 Dec 1;29(6):647-653. doi: 10.3171/2018.5.SPINE171380. Epub 2018 Sep 14.

  PMID: 30215593 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 21, 2016
• Study Start: January 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 21, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share