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