Preemptive Analgesia for Postoperative Pain Relief in Thoraco-lumbo-sacral Spine Surgery: a Double-blinded Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 99
- Primary Endpoint
- low back pain
Study Overview
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.
Detailed Description
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.
Exclusion criteria would be:
- 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 All subjects will be provided information about the study at their surgical appointment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •adult patients
- •8 years of age or older
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
low back pain
Time Frame: 24 hours
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Linda S Aglio
Principal Investigator
Brigham and Women's Hospital