Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion

Study Overview
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Brief Summary
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The following is a double blinded, randomized controlled clinical trial to test the hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single intra-operative epidural injection of Ropivaciane® will result in decreased postoperative pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2) Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if there are differences in pain management between MIS and open surgical procedures. The proposed study will add novel information to current knowledge by 1) exploring of the effects of intra-operative single epidural injection analgesic on patients receiving MIS compared to open surgery, and 2) investigate potential immediate and short-term functional improvements gained from intra-operative single injection of Ropivaciane®.

Detailed Description
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This double blinded, randomized clinical trial will test hypotheses by administering a single epidural injection prior to wound closure of either Ropivaciane® or saline.All pre-surgical activities and anesthesia will proceed as usual, with the addition of a single epidural injection immediately prior to wound closure 2 levels, or 10cm above the operated spinal level. Experimental groups will receive 0.2% Ropivaciane® (10 ml; dose shown to be effective without transient weakness), 9 and the control group will receive 0.9% saline solution (10 ml). Accurate placement into the space will be verified by the injection of contrast medium (iohexol, 180 mgl/ml) under fluoroscopic guidance. Epidural solutions will be prepared prior to surgery by pharmacy and coded; surgeons will administer according to the patient's code maintaining the double-blind procedure. It is important to note that treatment as usual differs between open and MIS cohorts. The question of interest is whether the addition of the epidural analgesic to current practices for each surgery type results in increased positive outcomes, whether this is due to synergistic effects or not. Following operative treatment, Foley Urinary catheter will be removed 24 hours post-operatively, unless otherwise clinically indicated.

Official Title
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Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Ropivacaine
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting participants undergoing elective 1-2 level lumbar fusion through the Canada East Spine Centre Exclusion Criteria: History of severe respiratory, renal or hepatic disease Previous spine surgery Known allergy to local anaesthesia Those who experience dural tear during operative procedure

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized into either the experimental arm (administration of Ropivaciane) or the control arm (administration of saline).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Administration of epidural Ropivaciane | Drug: Ropivacaine<br>* Administration of Ropivaciane via epidural injection intra-operatively<br>|
| Placebo Comparator: Control<br>Administration of saline | Other: Saline<br>* Administration of saline via epidural injection intra-operatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | Back and leg pain measured using the validated Numeric Rating Scales (NRS) for back and leg pain. | Administered 6 weeks pre-operatively, 2, 4, 8, 12, 24 and 48 hours post-operatively, 6 months post operatively, and 12 months post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Disability | Measurement of disability attributed to back problem using the validated Oswestry Disability Index (ODI). | Administered 6 weeks pre-operatively, 6 and 12 months post-operatively | 
| Change in General Health | Measurement of overall general health as measured by the validated Short Form General Health Survey (SF-12) | Administered 6 weeks pre-operatively, 6 and 12 months post-operatively | 
| Change in Medication Use | Medication used to control pain post-operatively as given by a qualified health professional while the patient is in hospital. | Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, analgesic, spinal fusion