Postoperative subQ Pain Control for Spinal Fusion Surgery

University of Arizona

Status and phase: Completed; Phase 2

Conditions: Spine Fusion; Surgery; Pain, Postoperative

Treatments: Drug: 0.25% Marcaine at 2ml/hr and pain medications; Device: Placement of OnQ Drug pump

Study type: Interventional

Funder types: Other

Identifiers

NCT03476811

1712090332

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient 18 years of age or greater
• Surgery to be done at Banner University Medical Center-Tucson
• Elective Surgeries only
• Lower Thoracic or Lumbar fusions only - Posterior Approach
• Postero or Posterolateral Instrumented Fusions with or without Interbody graft
• Transforaminal Interbody Fusions
• Must be able to cooperate in the daily VAS assessment

Exclusion criteria

• Patients under 18 years of age
• Prisoners
• Pregnant women
• Hypersensitivity to infusion medication
• Deformity Correction cases requiring osteotomies
• Surgical fusion in acute phase for traumatic injury
• Anterior Lumbar Interbody Fusion, Direct Lateral Interbody Fusion procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 3 patient groups, including a placebo group

Control Group

No Intervention group

Description:

Normal treatment paradigm (no anesthetic pump) with pain medications, only.

Marciano Group

Active Comparator group

Description:

Subcutaneous pain control with OnQ pump (0.25% Marcaine at 2ml/hr) and pain medications.

Treatment:

Drug: 0.25% Marcaine at 2ml/hr and pain medications

Placebo Group

Placebo Comparator group

Description:

OnQ pump with placebo (normal saline at 2ml/hr) and pain medications.

Treatment:

Device: Placement of OnQ Drug pump