Clinical trial NCT01861743: Multimodal Analgesia Versus Routine Care Pain Management
Official title: Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Degenerative Disc Disease Lumbar
Spinal Stenosis
Lumbar Spondylolisthesis
Keywords: Multi-modal Pain Management
Lumbar fusion
misTLIF
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is associated with an increased risk of developing chronic pain and delayed wound healing.

Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization. The most common post-operative analgesia used in spine surgery is narcotic medication delivered via an intravenous patient controlled analgesia (IV PCA).

A multimodal peri-operative pain management protocol for spine surgery has the potential to not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease length of stay in the hospital and reduce both direct and indirect hospital costs.

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 compared to usual analgesic care.

Detailed description: We hypothesize patients undergoing spinal fusion who receive peri-operative MMA will have:

1. decreased post-operative pain compared to patients receiving usual care for pain management.
2. shorter hospital LOS compared to patients receiving usual care pain management.
3. fewer analgesic-related post-operative complications (urinary retention, ileus, etc) compared to patients receiving usual care pain management.
4. improved physical functioning at the time of hospital discharge compared to patients receiving usual care pain management.
5. better short and long term outcomes. Subjects will be randomized to MMA (Group 1) or usual care (Group 2). The unit of randomization will be a week (Monday through Sunday). Each week will randomly be assigned to MMA or usual care. Subjects who are hospitalized into a consecutive week will continue with the pain regimen they were assigned upon hospitalization.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing single level MIS-TLIF
* Patients able to provide informed consent

Exclusion Criteria:

* Allergies or other contraindications to medicines in the protocol
* Current liver disease with documented liver function test abnormality
* Current renal disese with documented glomerular filtration rate (GFR) \< 60 mL/min/1.73m2
* Baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day
* Active alcohol dependence
* Active illicit drug dependence

Primary outcomes:
measure: Numeric pain scale
timeFrame: Patients will be followed post-operatively while in the hospital (Avg 1-3 days), and a 6 weeks, 3 months, 6 months, 1 year and 2 years.
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Post operatively (avg: 1-3 days)
Other outcomes:
measure: Length of Stay
timeFrame: Post operatively (avg: 1-3 days)
measure: Discharge destination
timeFrame: Post operatively (avg:1-3 days)
measure: Adverse events
timeFrame: Post operatively (avg: 1-3 days)
measure: Disease specific and General health outcome measures
timeFrame: Pre operatively (within 1 month of date of surgery) and Post operatively (6 weeks, 3months, 6 months, 1 year and 2 years)
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center-Orthopedic Spine
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Frank M Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JC, Choi YS, Kim KN, Shim JK, Lee JY, Kwak YL. Effective dose of peri-operative oral pregabalin as an adjunct to multimodal analgesic regimen in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2011 Mar 15;36(6):428-33. doi: 10.1097/BRS.0b013e3181d26708.
citation: Rajpal S, Gordon DB, Pellino TA, Strayer AL, Brost D, Trost GR, Zdeblick TA, Resnick DK. Comparison of perioperative oral multimodal analgesia versus IV PCA for spine surgery. J Spinal Disord Tech. 2010 Apr;23(2):139-45. doi: 10.1097/BSD.0b013e3181cf07ee.