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

NCT ID: NCT03640338

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-12-31

Brief Summary

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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

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Cold-therapy system

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.

Group Type EXPERIMENTAL

Cold-Therapy System

Intervention Type DEVICE

After surgery, participants assigned to this group will receive the cold-therapy system to use at the hospital and during the first 2 weeks following discharge.

Standard care (ice-pack)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cold-Therapy System

After surgery, participants assigned to this group will receive the cold-therapy system to use at the hospital and during the first 2 weeks following discharge.

Intervention Type DEVICE

Other Intervention Names

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Polar Care Kodiak, Breg®

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kern Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Other Identifiers

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18050401

Identifier Type: -

Identifier Source: org_study_id