Clinical trial NCT03035656: Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion
Official title: Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Pain
analgesic
spinal fusion
Lead sponsor: Horizon Health Network
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 228
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized into either the experimental arm (administration of Ropivaciane) or the control arm (administration of saline).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain
timeFrame: 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 outcomes:
measure: Change in Disability
timeFrame: Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
measure: Change in General Health
timeFrame: Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
measure: Change in Medication Use
timeFrame: Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.
Other outcomes:
measure: Change in Ambulation
timeFrame: Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.
measure: Adverse Events
timeFrame: The total number of adverse events will be measured at the time of patient discharge, between 48 hours and 120 hours following surgical intervention
Locations:
Study officials:
affiliation: Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery
name: Neil A Manson, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery
name: Edward P Abraham, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
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