Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study

Single Level Lumbar Decompression and Fusion Spine Surgery Clinical Trial

Official title:

Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02202369
• Other study ID #: 9080
• Status: Suspended
• Phase: Phase 4
• Start date: June 25, 2015
• Est. completion date: December 31, 2050

Study information

• Verified date: April 2024
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: December 31, 2050
• Est. primary completion date: February 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects undergoing a single level lumbar decompression and fusion

2. > 18 years of age and < 70 years of age

3. The subject is willing and able to understand, sign and date the study specific patient informed consent and HIPAA authorization to volunteer participation in the study

Exclusion Criteria:

1. Patients with liver disease (documented liver function test abnormality)

2. Patients with renal disease (documented glomerular filtration rate < 60mL/min/1.73m2)

3. Patients with a baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day.

4. Patients with active alcohol dependence

5. Patients with active illicit drug dependence

6. Patients < 18 years of age and >70 years of age

7. Patients allergic to any medication given in either arm (list medications)

8. Patients who have a seizure disorder

Related Conditions & MeSH terms

• Single Level Lumbar Decompression and Fusion Spine Surgery

Intervention

Other:
• Multimodal Analgesia Treatment
Subjects are given medications preop (Pregabalin, Oxycodone, Acetaminophen, Transdermal Scopolamine, Cyclobenzaprine), intraop (Propofol induction, Sevoflorane maintenance, Dexamethasone, Fentanyl, Ketamine, Marcaine, Zofran) and postop(Acetaminophen, Pregabalin, Tramadol, Cyclobenzaprine) that implement a multi-modal approach to managing pain.
• Standard of Care Pain Management Protocol
Subjects will be treated with patient controlled (standard of care) narcotic analgesia for pain management. (Marcaine, Dexamethasone, Zofran, Morphine, Acetaminophen, Cyclobenzaprine)

Locations

Country	Name	City	State
United States	OrthoCarolina	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.	Charlotte Orthopedic Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported pain level using a verbal numeric pain scale (NPS)	While in the hospital, patient's pain is assessed by a nurse-driven standard of care protocol. Assessments are typically every four to six hours or within 60 minutes after receiving an intravenous or oral analgesic medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.	In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days)
Secondary	Patient satisfaction	As part of the nurse driven standard of care protocol, patients are asked if their pain level is acceptable during their stay in the hospital	In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days)
Secondary	Narcotic consumption	The total amount of narcotic use during the course of hospitalization for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents	In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days)
Secondary	Length of stay	The number of hours of hospitalization from entering the recovery room (time zero) until the patient meets discharge criteria	Hospital discharge (an expected average of 2 days after surgery)
Secondary	Discharge destination	As standard of care this data point will be documented in the patients chart. It is categorized as patient home, rehabilitation facility, or skilled nursing facility	Hospital discharge (an expected average of 2 days after surgery)
Secondary	Oswestry Disability Index (ODI)	A disease specific questionnaire	pre-operative, 2 week post-operative, 6 week post-operative, 3 month post-operative, 6 month post-operative, 1 year post-operative, 2 year post-operative
Secondary	The Veterans Rand 12 (VR-12)	A general health questionnaire	pre-operative, 2 week post-operative, 6 week post-operative, 3 month post-operative, 6 month post-operative, 1 year post-operative, 2 year post-operative