Pain, Postoperative Clinical Trial
Official title:
Analgesic Duration of Interscalene Block After Outpatient Arthroscopic Shoulder Surgery With Intravenous Dexamethasone, Dexmedetomidine or Their Combination: A Randomized Controlled Trial
In this single-centre, double-blinded, randomized controlled superiority trial, 189 participants having outpatient, arthroscopic shoulder surgery will be randomized into 3 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg of dexamethasone or 50mcg of dexmedetomidine or both intravenously just prior to their surgery. The purpose of this study is to provide a head to head comparison of two types intravenous adjuncts to ISB, corticosteroids and alpha 2 agonists, and determine if their combination, or either one alone provides superior postoperative analgesia in arthroscopic shoulder surgery patients, as well as possibly show a synergistic relationship between the two adjuncts. The investigators hypothesize the combination of adjuncts will provide a longer duration of analgesia compared to either single agent.
BACKGROUND & RATIONALE Optimal postoperative analgesia is very important in the ambulatory
arthroscopic shoulder surgery patient population; interscalene blocks are used for this
surgery because they reduce acute pain and have opioid sparing effects postoperatively. While
older patients, higher ASA grades and more complex arthroscopic procedures are risk factors
for unplanned overnight admissions, in the ambulatory surgery setting, poor analgesia is one
of the most common reasons a patient visits a health care provider after their surgery.
Approximately 30 % of patients undergoing arthroscopic surgery globally experience
significant postoperative pain within the first 24 hours post surgery. In light of this,
interscalene brachial plexus blockade (ISB) has been found to be the most effective and
preferred method of analgesia for arthroscopic shoulder surgeries when compared to
subacromial/intra-articular injections, cryotherapy and oral pain medications. ISB usually
consists of a single injection of local anesthetic, anywhere from 5 to 30 minutes prior to
shoulder surgery. Although ISB reduces postoperative pain in arthroscopic shoulder surgeries,
the length of analgesia from a single injection of local anesthetic is limited to 6 to 15
hours after surgery. Due to the limited duration of analgesia, interscalene catheters have
been studied for prolongation of analgesia via continuous infusion of local anesthetics.
Although continuous catheter infusions are effective and feasible, there exist several
complications such as dyspnea, peripheral neuropathies, nausea, and practical challenges that
limit their wider application in an ambulatory setting. Recently, different adjuncts given in
combination with local anesthetics have been used to prolong the analgesic duration of a
single injection ISB. These adjuncts have been given by both the intravenous and by the
perineural routes, where perineural means the adjunct is injected with the local anesthetic
around the brachial plexus.
Dexamethasone, a potent glucocorticoid, has been shown in multiple studies to prolong the
duration of analgesia of the ISB compared to placebo when administered either perineurally or
intravenously. A recently completed large trial (in press) at our centre showed that the
duration of analgesia (mean (standard deviation), in hours (h)) with 4mg of intravenous
dexamethasone (24.0 (4.6)h) is not significantly different from 8mg (24.8 (6.4)h) and only
slightly shorter than perineural dexamethasone doses of 4mg (25.4 (6.6)h) or 8mg (27.2
(8.5)h). The 4mg intravenous dose was favored given the established safety of the intravenous
route, its approximately equivalent effectiveness compared to the higher 8mg dose and the
absence of differences in adverse effects between groups.
Dexmedetomidine, a highly selective α2 adrenergic agonist with sedative and analgesic
properties, has also been shown to potentiate peripheral nerve blockade and prolong the
duration of analgesia versus placebo when used as an adjunct to local anesthetic for regional
anesthesia, including interscalene block. Most studies have compared perineural
dexmedetomidine to placebo, as is the case for other adjuncts such as dexamethasone, even
though there is less experience with the perineural route for dexmedetomidine compared to
dexamethasone. Interestingly, a recent study found both intravenous and perineural
dexmedetomidine reduced the 24 hour opioid consumption and comparably prolonged the duration
of ISB analgesia compared to placebo. In a recent meta-analysis, a 50-60ug Dexmedetomidine
perineural or intravenous dose maximized sensory block duration while minimizing hemodynamic
side effects.
To our knowledge, there are no published studies comparing the analgesic duration of ISB
between dexamethasone and dexmedetomidine, and no studies have evaluated whether there is
additional benefit to administering these widely available medications in combination. Three
ongoing studies are comparing dexamethasone and dexmedetomidine as single adjuncts, without a
combination. All three of these studies are using the perineural route, despite the
established safety and effectiveness of the intravenous route for both drugs. With this study
we are seeking to improve our patients' postoperative experience with superior analgesia by
better defining the relative analgesic effectiveness of dexamethasone and dexmedetomidine
when given alone or in combination as intravenous adjuncts to ISB.
OBJECTIVES AND HYPOTHESES
In outpatients undergoing arthroscopic shoulder surgery with Interscalene Block:
I. To determine if there is a significant increase in duration of analgesia when combining
intravenous dexamethasone and dexmedetomidine compared to administering each adjunct
individually. We hypothesize the combination of adjuncts will provide a longer duration of
analgesia compared to either single agent.
II. To compare the effect of Dexamethasone to Dexmedetomidine on duration of analgesia when
given individually. We hypothesize that there will be no significant difference between the
two adjuncts.
METHODS This single-centre, double-blinded, randomized controlled superiority trial has three
parallel groups and 1:1:1 randomization. Consenting and eligible adult ambulatory patients
undergoing arthroscopic shoulder surgery will receive preoperative, ultrasound guided ISB
with 30 millilitres (mL) of 0.5% bupivacaine and 4mg of preservative free dexamethasone or
50mcg of dexmedetomidine or both intravenously. The remainder of the intraoperative and
postoperative care is at the discretion of the attending anesthesiologist and surgeon. The
primary outcome is analgesic block duration. The power analysis for this study was based on
published results from previous studies, as well as our recent work. With a two-tailed alpha
error of 0.05, and a standard deviation of 5.0 hours in each group, 180 total patients would
provide greater than 90% power to detect a difference of 3.0 hours in block duration. To
account for a 5% attrition rate we propose recruiting 63 patients per group (189 patient's
total). Outcomes will be assessed by chart review and telephone follow up on postoperative
day one, postoperative day 2 (if necessary), and postoperative day 14.
After collecting 102 primary outcomes, we will compare the primary outcome between the
combination and each of the single adjuncts. At this point the study will be 90% powered to
detect a difference of 6.0h in block duration, even if the standard deviations are higher
than expected, at 7.5 hours. If the combination is superior to both of the single agents, the
study will be terminated. The principle investigator cancelled this interim analysis on 18
December 2017 after consultation with the study statistician and research team. After
reconsidering the original power calculations, the clinically plausible differences between
groups, and the high level of statistical significance recommended for interim analyses, it
was determined that this interim analysis would be very unlikely to convincingly demonstrate
the superiority of the combination over the single agents. As of 18 December 2017 90 patients
have participated in the study and recruitment is on schedule. The entire research team has
been and will continue to be blinded to outcome data by group assignment until all 189
patients have participated, which is expected to occur in the second quarter of 2018.
The primary outcome analysis will analyze by intention to treat only those patients who were
randomized and did receive an attempt at an interscalene block. A secondary analysis will
exclude patients who had a "failed" interscalene block in the post anesthesia care unit. A
tertiary analysis will be a multivariable analysis adjusted for demographics, preoperative
naproxen use, use of general anesthesia, cumulative analgesic use and failed interscalene
block.
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