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

NCT03640338 | Withdrawn

• 1 other identifier: 18050401
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain

  Average daily Visual Analog Scale (VAS) survey, which measures pain, for the duration of hospital stay and postoperative VAS scores will be recorded for 2 years postoperatively. This information will be collected through a survey that will be administered upon patient discharge. Patients will be asked to return the completed survey to the research team. VAS scale ranges from 0 - 100 mm, with 100 representing maximum pain and 0 representing no pain.

  2 year postoperative

• Narcotics Consumption

  Total, daily, and hourly narcotics consumption during the hospitalization. Narcotic consumption will be recorded for 2 weeks following discharge. Patients will be asked to report the number of narcotic pills taken each day. This information will be collected through a survey that will be administered upon patient discharge. Patients will be asked to return the completed survey to the research team.

  2 weeks postoperative

Secondary Outcomes (6)

• Bony fusion

  2 year postoperative

• Disability

  2 year postoperative

• Physical Function: Patient-Reported Outcomes Measurement Information System (PROMIS)

  2 year postoperative

• General Health Status: Short-Form (SF-12)

  2 year postoperative

• Length of Stay

  Up to 2 weeks

Study Arms (2)

Cold-therapy system

EXPERIMENTAL

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.

Device: Cold-Therapy System

Standard care (ice-pack)

NO INTERVENTION

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

Interventions

Cold-Therapy System 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.

Also known as: Polar Care Kodiak, Breg®

Cold-therapy system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient able to provide informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead

MeSH Terms

Conditions

Radiculopathy; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Kern Singh, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 21, 2018
• Study Start: April 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share