NCT03476811

Postoperative subQ Pain Control for Spinal Fusion Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Post-operative pain following lumbar spine fusion is frequently difficult to manage and can lead to increased doses of opiate pain medications to control pain. In this study, the use of subcutaneous local anesthesia will be studied to determine its efficacy at reducing post-operative pain following spinal fusion surgery.

Detailed description

For patients randomized to the experimental or to the placebo groups, two subcutaneous catheters will be tunneled under the skin with large hollow-bore needles along the entire length of the incision on either side prior to closure. These catheters will deliver study drug (0.25% Marcaine) directly into the incision. They will be affixed to the skin with steri-strips. The catheters will then be attached to a drug delivery pump at 2mL/hour and will be removed prior to discharge.

Conditions

• Spine Fusion
• Surgery
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	0.25% Marcaine at 2ml/hr and pain medications	Subcutaneous pain control with OnQ Subcutaneous Drug pump
DEVICE	Placement of OnQ Drug pump	Subcutaneous placement of OnQ drug pump with normal saline infusion

Timeline

• Start date: 2018-02-09
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2018-03-26
• Last updated: 2022-05-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study