NCT03640338

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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).

Conditions

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2020-04-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2018-08-21
• Last updated: 2020-11-23