Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-29 @ 8:19 PM
Study NCT ID:
NCT02202369
Status:
SUSPENDED
Last Update Posted:
2025-04-28
First Post:
2014-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study
Sponsor:
OrthoCarolina Research Institute, Inc.
Organization:
Study Overview
Official Title:
Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study
Status:
SUSPENDED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment and subject followup rates
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA (multimodal analgesia) compared to usual analgsic care.
Detailed Description:
Specific Aim #1: To compare the postoperative pain levels of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
Controlling postoperative pain is a critical first step in facilitating a patient's recovery and improved quality of life. In-hospital pain levels will be measured using a numeric pain scale on a scale of 0-10. Pain assessment is conducted by the hospital nurses as a standard of care protocol. Assessments are every four to six hours, within 60 minutes after receiving a pain medication
Hypothesis: Patients treated with the MMA pain protocol will have significantly less immediate postoperative pain as compared to patients treated with the standard pain protocol.
Specific Aim #2: To compare the immediate postoperative, or in-hospital, narcotic consumption of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
Decreasing narcotic consumption following lumbar spinal fusion surgery is important for faster recovery for the patient, decreasing narcotic related side effects (nausea and vomiting, lethargy, ileus, etc) as well as lowering overall treatment costs. The total amount of narcotic use during the course of the hospitalization for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents.
Hypothesis: Patients treated with the MMA pain protocol will consume significantly less immediate postoperative narcotic pain medications compared to patients treated with the standard pain protocol.
Specific Aim #3: To compare the length of hospital stay of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
Decreasing the amount of time patients remain in the hospital may decrease the time it takes a patient to return to personal and societal responsibilities. Additionally it reduces the patients risk of a nosocomial infection and reduces the costs of the surgery.
Hypothesis: Patients treated with the MMA pain protocol will have a significantly reduced length of stay in the hospital compared to patients treated with the standard pain protocol.
Specific Aim #4: To compare postoperative quality of life of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
The primary purpose of lumbar fusion surgery is to improve the quality of life for patients. The Oswestry Disability Index (ODI) will be used as a disease specific measure. The Veterans Rand 12 (VR-12) will be used as a general health outcome measure. Each of these patient reported outcome measures will be collected pre-operatively and at each of the following postoperative visits: 2 weeks, 6 weeks, 3 month, 6 visit, 1 visit, and 2 year.
Hypothesis: Patients treated with the MMA pain protocol will have significantly greater improvement in Quality of Life measures compared to patients treated with the standard pain protocol and this will be sustained out to two years post-operatively.
Controlling postoperative pain is a critical first step in facilitating a patient's recovery and improved quality of life. In-hospital pain levels will be measured using a numeric pain scale on a scale of 0-10. Pain assessment is conducted by the hospital nurses as a standard of care protocol. Assessments are every four to six hours, within 60 minutes after receiving a pain medication
Hypothesis: Patients treated with the MMA pain protocol will have significantly less immediate postoperative pain as compared to patients treated with the standard pain protocol.
Specific Aim #2: To compare the immediate postoperative, or in-hospital, narcotic consumption of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
Decreasing narcotic consumption following lumbar spinal fusion surgery is important for faster recovery for the patient, decreasing narcotic related side effects (nausea and vomiting, lethargy, ileus, etc) as well as lowering overall treatment costs. The total amount of narcotic use during the course of the hospitalization for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents.
Hypothesis: Patients treated with the MMA pain protocol will consume significantly less immediate postoperative narcotic pain medications compared to patients treated with the standard pain protocol.
Specific Aim #3: To compare the length of hospital stay of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
Decreasing the amount of time patients remain in the hospital may decrease the time it takes a patient to return to personal and societal responsibilities. Additionally it reduces the patients risk of a nosocomial infection and reduces the costs of the surgery.
Hypothesis: Patients treated with the MMA pain protocol will have a significantly reduced length of stay in the hospital compared to patients treated with the standard pain protocol.
Specific Aim #4: To compare postoperative quality of life of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
The primary purpose of lumbar fusion surgery is to improve the quality of life for patients. The Oswestry Disability Index (ODI) will be used as a disease specific measure. The Veterans Rand 12 (VR-12) will be used as a general health outcome measure. Each of these patient reported outcome measures will be collected pre-operatively and at each of the following postoperative visits: 2 weeks, 6 weeks, 3 month, 6 visit, 1 visit, and 2 year.
Hypothesis: Patients treated with the MMA pain protocol will have significantly greater improvement in Quality of Life measures compared to patients treated with the standard pain protocol and this will be sustained out to two years post-operatively.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: