Pain, Postoperative
Conditions
Keywords
Pain, analgesic, spinal fusion
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.
Interventions
DRUGRopivacaine
Administration of Ropivaciane via epidural injection intra-operatively
OTHERSaline
Administration of saline via epidural injection intra-operatively
Sponsors
Horizon Health Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomization of arms are conducted by the pharmacy department, and drug or saline preparation are prepared by the pharmacy department.
Intervention model description
Patients are randomized into either the experimental arm (administration of Ropivaciane) or the control arm (administration of saline).
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 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 | Back and leg pain measured using the validated Numeric Rating Scales (NRS) for back and leg pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disability | Administered 6 weeks pre-operatively, 6 and 12 months post-operatively | Measurement of disability attributed to back problem using the validated Oswestry Disability Index (ODI). |
| Change in General Health | Administered 6 weeks pre-operatively, 6 and 12 months post-operatively | Measurement of overall general health as measured by the validated Short Form General Health Survey (SF-12) |
| Change in Medication Use | Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively. | Medication used to control pain post-operatively as given by a qualified health professional while the patient is in hospital. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Ambulation | Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively. | The patient's ability to walk following surgery as measured using Ortho-Care Step Watch Activity Monitors (SAM) which will be attached to the patient's ankle during their stay in hospital. |
| Adverse Events | The total number of adverse events will be measured at the time of patient discharge, between 48 hours and 120 hours following surgical intervention | Adverse Events (AEs) will be measured using the validated Spine Adverse |
Contacts
Primary ContactErin E Bigney, BA MA
Backup ContactEden A Richardson, BA
Outcome results
None listed