Clinical trial NCT03640338: The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion
Official title: The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Radiculopathy
Central Spinal Stenosis
Foraminal Stenosis
Herniated Nucleus Pulposus
Degenerative Disc Disease
Isthmic Spondylolisthesis
Degenerative Spondylolisthesis
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patient outcomes and satisfaction are an ever-increasing priority in surgical specialties. Cryotherapy has been utilized following spine surgery as an adjunct therapy to reduce postoperative inflammation and improve patient outcomes. However, limited studies have investigated the effect of cryotherapy on postoperative pain and narcotics use. Fountas et al. performed a randomized controlled trial to assess the impact of postoperative cryotherapy following single-level lumbar microdiscectomy. The authors reported patients receiving cryotherapy required significantly less pain medication (0.058 mg/kg/hr versus 0.067 mg/kg/hr, p\<0.001) and had shorter hospital stays (1.71 days versus 2.65 days, p\<0.001) as compared to the control group. In another randomized trial of single-level lumbar discectomy patients, Murata et al. demonstrated cryotherapy to have no significant effect on VAS inpatient pain scores or postoperative blood loss.

Detailed description: The purpose of this study is to determine if postoperative cryotherapy with a cold-therapy system reduces postoperative pain and narcotic consumption following single and multi-level spinal fusion.

The investigators hypothesize that patients undergoing lumbar spinal fusion who receive postoperative cryotherapy treatment with a cold-therapy system will have reduced inpatient pain scores and require less narcotics as compared to patients that receive standard care (ice pack).

Eligibility criteria: Inclusion Criteria:

1. Single or multi-level lumbar spinal fusion for degenerative pathology, including: radiculopathy, central spinal stenosis, foraminal stenosis, herniated nucleus pulposus, degenerative disc disease, and isthmic or degenerative spondylolisthesis.
2. Patient able to provide informed consent

Exclusion Criteria:

1. Chronic preoperative narcotic use defined as daily narcotic use for the past 6 months prior to surgery
2. Workers' compensation insurance claim
3. Active or history of malignancy
4. Unable to speak, read, or comprehend English language

Primary outcomes:
measure: Postoperative Pain
timeFrame: 2 year postoperative
measure: Narcotics Consumption
timeFrame: 2 weeks postoperative
Secondary outcomes:
measure: Bony fusion
timeFrame: 2 year postoperative
measure: Disability
timeFrame: 2 year postoperative
measure: Physical Function: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 2 year postoperative
measure: General Health Status: Short-Form (SF-12)
timeFrame: 2 year postoperative
measure: Length of Stay
timeFrame: Up to 2 weeks
measure: Disposition on discharge
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Rush University Medical Center
name: Kern Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: