Postoperative subQ Pain Control for Spinal Fusion Surgery

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-09

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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

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Spine Fusion Surgery Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This trial is a comparative trial investigating outcomes in 3 parallel groups. The control group will receive standard of care pain control following surgery, the Marcaine group will receive infusion of FDA approved Marcaine around the operative site following surgery through an FDA approved surgical device. The Placebo group will have the drug delivery device implanted with delivery of saline.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Marciano Group

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

Group Type ACTIVE_COMPARATOR

0.25% Marcaine at 2ml/hr and pain medications

Intervention Type DRUG

Subcutaneous pain control with OnQ Subcutaneous Drug pump

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placement of OnQ Drug pump

Intervention Type DEVICE

Subcutaneous placement of OnQ drug pump with normal saline infusion

Interventions

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0.25% Marcaine at 2ml/hr and pain medications

Subcutaneous pain control with OnQ Subcutaneous Drug pump

Intervention Type DRUG

Placement of OnQ Drug pump

Subcutaneous placement of OnQ drug pump with normal saline infusion

Intervention Type DEVICE

Other Intervention Names

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OnQ Subcutaneous Drug pump

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes