The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion

Rush

Status: Withdrawn

Conditions: Isthmic Spondylolisthesis; Degenerative Disc Disease; Foraminal Stenosis; Radiculopathy; Degenerative Spondylolisthesis; Herniated Nucleus Pulposus; Central Spinal Stenosis

Treatments: Device: Cold-Therapy System

Study type: Interventional

Funder types: Other

Identifiers

NCT03640338

18050401

Details and patient eligibility

About

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.

Full 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).

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Cold-therapy system

Experimental group

Description:

Patients will receive a cold-therapy system postoperatively (Polar Care Kodiak, Breg®) and will use the system during inpatient stay and during the first 14 days post-discharge.

Treatment:

Device: Cold-Therapy System

Standard care (ice-pack)

No Intervention group

Description:

Patients will use disposable ice-pack as per standard of care