Pain, PostoperativePhase 4NCT02426736
Effect of Dexamethasone Dose and Route on Duration of Interscalene Block After Outpatient Shoulder Surgery
A Phase 4 study testing Dexamethasone, Bupivacaine and Interscalene brachial plexus block in people with Pain, Postoperative and Disorder of Shoulder, run by University of Manitoba at 1 site in Canada.
Trial summary
In this factorial design study, 280 participants having outpatient, arthroscopic shoulder surgery will be randomized into 4 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg or 8mg of dexamethasone given by the intravenous or perineural (by the nerve with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Disorder of Shoulder
- What is being tested?
- Dexamethasone, Bupivacaine and Interscalene brachial plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jun 2015to 12 Jan 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective ambulatory surgery patients undergoing arthroscopic shoulder surgery
- Including rotator cuff repair
- Stabilization procedures
- Acromioplasty
- Debridement and distal clavicle excision
Who cannot join
- Patient refusal, diabetes
- Pregnancy
- Coagulopathy significant enough to be a contraindication to regional anesthesia as determined by the attending anesthesiologist
- Sensitivity to local anesthetics or dexamethasone
- Severe chronic obstructive pulmonary disease
- Contralateral vocal cord paralysis
Show all 17Show fewer
- Contralateral diaphragmatic paralysis
- Surgical limb brachial plexus neuropathy
- Interscalene block site infection
- Systemic glucocorticoids in the last 2 weeks
- Epidural or intraarticular steroid injection in the past 3 months
- Chronic opioid use defined as daily use for the last two weeks
- International normalized ratio (INR) > 1.5
- Active peptic ulcer disease
- End-stage renal disease
- Cirrhotic liver disease
- Previous participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexamethasone Dose and Route on Duration of Interscalene Brachial Plexus Block for Outpatient Arthroscopic Shoulder Surgery - A Randomized Controlled Trial
In this factorial design study, 280 participants having outpatient, arthroscopic shoulder surgery will be randomized into 4 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg or 8mg of dexamethasone given by the intravenous or perineural (by the nerve with the nerve block) route just prior to their surgery. The purpose of this study is to determine which dose and route of dexamethasone provides the longest duration of pain control and the fewest side effects after surgery. The investigators hypothesize that giving dexamethasone by the perineural route, and by higher doses, will result in the longer durations of pain control, without increased side effects.
Read the detailed description
BACKGROUND \& RATIONALE Interscalene brachial plexus blockade (ISB) has emerged as the choice method of analgesia for arthroscopic shoulder surgery performed on an outpatient basis. The ISB is typically administered as a single injection of local anesthetic prior to surgery. Benefits include reduced pain, opioid consumption and postoperative nausea and vomiting on the first postoperative day. However, the limited duration of analgesia with a single injection of local anesthetic, typically 12 to15 hours, is inadequate for many patients. Recent interest in prolonging the analgesic duration of single injection ISB has been focused on the addition of various adjuncts to the local anesthetic, with varying degrees of success.
Dexamethasone is the most promising of these adjuncts, with both perineural and intravenous administration consistently resulting in increased analgesic duration, by as much as two-fold. Nevertheless, it would seem prudent to administer perineural adjuncts at the lowest effective dose and only if they offer significant benefit over other routes of administration.
The multiple small clinical studies published to date have used dexamethasone doses between 4 and 10mg for both intravenous and perineural routes. Attributing differences in results between any of these studies to the dose and route of dexamethasone administered is not possible due to differences in drugs, doses, study populations and methodology. Most importantly, no study has compared two different doses of dexamethasone and the only two studies that compared the intravenous and perineural routes arrived at different conclusions. Thus, the effect of dexamethasone dose and route on the analgesic duration of interscalene block remains unclear, with multiple recent editorials and meta-analyses calling for further study. In light of these gaps in the evidence, a trial elucidating the effect of dose and route of administration of dexamethasone on analgesic duration of ISB is required. This is the focus of our proposed study.
OBJECTIVES AND HYPOTHESES In this factorial design study of outpatients undergoing elective arthroscopic shoulder surgery with interscalene brachial plexus block (ISB), the investigators will compare perineural and intravenous administration of dexamethasone at high (8mg) and low (4mg) doses. The investigators hypothesize that high doses and the perineural route will provide significantly longer duration of analgesia, without significant statistical interaction between dose and route of administration.
METHODS This single-centre, factorial design, double-blinded, randomized controlled superiority trial has four parallel groups and 1:1:1:1 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 or 8mg of preservative free dexamethasone either intravenous or perineural. The remainder of the intraoperative and postoperative care is at the discretion of the attending anesthesiologist and surgeon. Based on previous work, with 70 patients per group, the study is at least 90% powered to detect a 3 hour difference in analgesia for dose or route, and a 4 hour synergistic interaction, even with a 5% attrition rate. Outcomes will be assessed by chart review and telephone follow up on postoperative day one, postoperative day 2 (if necessary), and postoperative day 14.
An interim analysis of group standard deviations only will occur after 100 patients have completed the study to determine if the original power calculations were accurate, and if testing for the interaction effect is feasible within the planned sample size of 280 participants. If testing for the interaction of dose and route is not feasible, a new study sample size will be determined, based on the number of participants needed to have 90% power to test the two main effects.
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" inter scalene 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 inter scalene block.
- Conditions
- Pain, Postoperative, Disorder of Shoulder
- Being tested
- Dexamethasone, Bupivacaine, Interscalene brachial plexus block
- Keywords
- Shoulder Joint, Arthroscopy, Ambulatory surgical procedures, Pain, Postoperative, Brachial Plexus Block, Corticosteroid, Dexamethasone, Bupivacaine, Perineural
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
BupivacaineDrug
Interscalene brachial plexus blockProcedure or surgery
Performed with real time ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Low dose intravenous dexamethasone | Active comparator | 4 milligrams dexamethasone administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block Receives: Drug: Dexamethasone; Drug: Bupivacaine; Procedure: Interscalene brachial plexus block |
| High dose intravenous dexamethasone | Active comparator | 8 milligrams dexamethasone administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block Receives: Drug: Dexamethasone; Drug: Bupivacaine; Procedure: Interscalene brachial plexus block |
| Low dose perineurial dexamethasone | Active comparator | 4 milligrams dexamethasone administered once perineurally with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block Receives: Drug: Dexamethasone; Drug: Bupivacaine; Procedure: Interscalene brachial plexus block |
| High dose perineurial dexamethasone | Active comparator | 8 milligrams dexamethasone administered once perineurally with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block Receives: Drug: Dexamethasone; Drug: Bupivacaine; Procedure: Interscalene brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia after interscalene block
Time from block performance to the first time shoulder pain was experienced after the surgery, rounded to the nearest 0.1 hours, as reported by the participant at telephone follow-up on postoperative day one, or if necessary, postoperative day 2.
Measured: Time-to-event outcome measure, assessed up to the end of postoperative day 2 (approximately 60 hours from performance of the block).
Secondary outcomes (14)
Block Success or Failure
The block will be considered "failed" if the patient required opioid analgesia for surgical site pain during their stay in the post anesthesia care unit, as determined by the patient's nurse. At our facility, patients are discharged home directly from the post anesthesia care unit.
Measured: Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after the performance of the block.
Severity of pain at the time the primary outcome occurred, measured on an 11-point numerical rating score.
11-point numerical rating score, with integers from 0 to 10 where 0 represents no pain and 10 represents worst imaginable pain. As reported by telephone follow up.
Measured: Assessed at the time that the primary outcome occurs, an expected average of 20 hours after performance of the block.
Cumulative Analgesic Consumption in the post anesthesia care unit, measured as equivalent milligrams of morphine.
Measured: "Change" outcome measure: From admission to the post anesthesia care unit (an expected average of 3 hours after performance of the block), to discharge from the post anesthesia care unit (an expected average of 5 hours after performance of the block).
Cumulative Analgesic Consumption from post anesthesia care unit discharge until the time the primary outcome occurred, measured as equivalent milligrams of morphine.
Measured: "Change" outcome measure: From discharge from the post anesthesia care unit (an expected average of 5 hours after performance of the block), to the occurrence of the primary outcome (an expected average of 20 hours after performance of the block).
Postoperative Nausea and/or vomiting measured on an 11-point numerical rating score.
11-point numerical rating score, with integers from 0 to 10 where 0 represents the symptom was completely absent and 10 represents the symptom was present the entire time since arrival to the post anesthesia care unit.
Measured: Assessed at telephone follow up on postoperative day one.
First postoperative night Sleep Quality, measured on an 11-point numerical rating score.
11-point numerical rating score, with integers from 0 to 10 where 0 represents a very poor sleep and 10 represents a very restful night's sleep.
Measured: Assessed at telephone follow up on postoperative day one.
Observed postoperative Dyspnea, as recorded in the post anesthesia care unit record.
As observed and recorded by the post anesthesia care unit nurse during the patient's stay in the post anaesthesia care unit.
Measured: Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after performance of the block.
Subjective postoperative Dyspnea, measured on an 11-point numerical rating score.
11-point numerical rating score, with integers from 0 to 10 where 0 represents the symptom was completely absent and 10 represents the symptom was present the entire time since admission to the post anesthesia care unit.
Measured: Assessed at telephone follow up on postoperative day one.
Restlessness and/or Anxiety, measured on an 11-point numerical rating score.
11-point numerical rating score, with integers from 0 to 10 where 0 represents the symptom was completely absent and 10 represents the symptom was present the entire time since admission to the post anesthesia care unit.
Measured: Assessed at telephone follow up on postoperative day one.
Motor and/or Sensory Block Dissatisfaction, measured on an 11-point numerical rating score.
11-point numerical rating score, with integers from 0 to 10 where 10 represents complete dissatisfaction and 0 represents no dissatisfaction.
Measured: Assessed at telephone follow up on postoperative day one
Likelihood of choosing this method of analgesia again, measured on an 11-point numerical rating score.
11-point numerical rating score, with integers from 0 to 10 where 10 "would for sure choose this method again", and 0 represents "would for sure not choose this method again".
Measured: Assessed at telephone follow up on postoperative day one
Unplanned Postoperative Hospital Admission, as reported at telephone follow up or chart review.
Transfer or admission to hospital during the postoperative period between admission to the post anesthesia care unit and telephone follow up on postoperative day one.
Measured: Assessed at telephone follow up and chart review on postoperative day one.
New Persistent Neurologic Symptoms
Patient will be asked whether they are experiencing any tingling, numbness or weakness in the surgical limb, or hoarseness or dyspnea. Patients answering yes to any of the above will be reassessed at 6 months postoperatively.
Measured: Assessed at postoperative day 14.
Post anesthesia care unit length of stay in minutes
Amount of time between admission and discharge from the post anesthesia care unit.
Measured: Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after performance of the block.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study start25 Jun 2015
- Primary completion12 Jul 2016
- Study completion12 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Mutter, University of Manitoba
- Investigators
- Thomas C Mutter, MD MSc, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426736
- Sponsor's protocol ID
- B2015:016
- Status last verified
- Oct 2017
- First submitted
- 14 Apr 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fortier J, Chung F, Su J. Unanticipated admission after ambulatory surgery--a prospective study. Can J Anaesth. 1998 Jul;45(7):612-9. doi: 10.1007/BF03012088.
PubMed 9717590Hughes MS, Matava MJ, Wright RW, Brophy RH, Smith MV. Interscalene brachial plexus block for arthroscopic shoulder surgery: a systematic review. J Bone Joint Surg Am. 2013 Jul 17;95(14):1318-24. doi: 10.2106/JBJS.L.01116. No abstract available.
PubMed 23864181Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
PubMed 20565394Wu CL, Rouse LM, Chen JM, Miller RJ. Comparison of postoperative pain in patients receiving interscalene block or general anesthesia for shoulder surgery. Orthopedics. 2002 Jan;25(1):45-8. doi: 10.3928/0147-7447-20020101-15.
PubMed 11811241Boezaart AP. Continuous interscalene block for ambulatory shoulder surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):295-310. doi: 10.1053/bean.2002.0239.
PubMed 12491559Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.
PubMed 24413428Bailard NS, Ortiz J, Flores RA. Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations, and recommendations. Am J Health Syst Pharm. 2014 Mar 1;71(5):373-85. doi: 10.2146/ajhp130336.
PubMed 24534592Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.
PubMed 21956081Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
PubMed 20009936Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.
PubMed 21676892Tandoc MN, Fan L, Kolesnikov S, Kruglov A, Nader ND. Adjuvant dexamethasone with bupivacaine prolongs the duration of interscalene block: a prospective randomized trial. J Anesth. 2011 Oct;25(5):704-9. doi: 10.1007/s00540-011-1180-x. Epub 2011 Jun 17.
PubMed 21681533Kim YJ, Lee GY, Kim DY, Kim CH, Baik HJ, Heo S. Dexamathasone added to levobupivacaine improves postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Feb;62(2):130-4. doi: 10.4097/kjae.2012.62.2.130. Epub 2012 Feb 20.
PubMed 22379567Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.
PubMed 23587875Kawanishi R, Yamamoto K, Tobetto Y, Nomura K, Kato M, Go R, Tsutsumi YM, Tanaka K, Takeda Y. Perineural but not systemic low-dose dexamethasone prolongs the duration of interscalene block with ropivacaine: a prospective randomized trial. Local Reg Anesth. 2014 Apr 5;7:5-9. doi: 10.2147/LRA.S59158. eCollection 2014.
PubMed 24817819De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
PubMed 21799397
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone Dose and Route on Duration of Interscalene Brachial Plexus Block for Outpatient Arthroscopic Shoulder Surgery - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02426736
- Acronym / sponsor ID
- B2015:016
- Conditions
- Pain, Postoperative, Disorder of Shoulder
- Keywords
- Shoulder Joint, Arthroscopy, Ambulatory surgical procedures, Pain, Postoperative, Brachial Plexus Block, Corticosteroid, Dexamethasone, Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 25 Jun 2015 (actual)
- Primary completion
- 12 Jul 2016 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this factorial design study, 280 participants having outpatient, arthroscopic shoulder surgery will be randomized into 4 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg or 8mg of dexamethasone given by the intravenous or perineural (by the nerve with the nerve block) route just prior to their surgery. The purpose of this study is to determine which dose and route of dexamethasone provides the longest duration of pain control and the fewest side effects after surgery. The investigators hypothesize that giving dexamethasone by the perineural route, and by higher doses, will result in the longer durations of pain control, without increased side effects.
Detailed description
BACKGROUND \& RATIONALE Interscalene brachial plexus blockade (ISB) has emerged as the choice method of analgesia for arthroscopic shoulder surgery performed on an outpatient basis. The ISB is typically administered as a single injection of local anesthetic prior to surgery. Benefits include reduced pain, opioid consumption and postoperative nausea and vomiting on the first postoperative day. However, the limited duration of analgesia with a single injection of local anesthetic, typically 12 to15 hours, is inadequate for many patients. Recent interest in prolonging the analgesic duration of single injection ISB has been focused on the addition of various adjuncts to the local anesthetic, with varying degrees of success.
Dexamethasone is the most promising of these adjuncts, with both perineural and intravenous administration consistently resulting in increased analgesic duration, by as much as two-fold. Nevertheless, it would seem prudent to administer perineural adjuncts at the lowest effective dose and only if they offer significant benefit over other routes of administration.
The multiple small clinical studies published to date have used dexamethasone doses between 4 and 10mg for both intravenous and perineural routes. Attributing differences in results between any of these studies to the dose and route of dexamethasone administered is not possible due to differences in drugs, doses, study populations and methodology. Most importantly, no study has compared two different doses of dexamethasone and the only two studies that compared the intravenous and perineural routes arrived at different conclusions. Thus, the effect of dexamethasone dose and route on the analgesic duration of interscalene block remains unclear, with multiple recent editorials and meta-analyses calling for further study. In light of these gaps in the evidence, a trial elucidating the effect of dose and route of administration of dexamethasone on analgesic duration of ISB is required. This is the focus of our proposed study.
OBJECTIVES AND HYPOTHESES In this factorial design study of outpatients undergoing elective arthroscopic shoulder surgery with interscalene brachial plexus block (ISB), the investigators will compare perineural and intravenous administration of dexamethasone at high (8mg) and low (4mg) doses. The investigators hypothesize that high doses and the perineural route will provide significantly longer duration of analgesia, without significant statistical interaction between dose and route of administration.
METHODS This single-centre, factorial design, double-blinded, randomized controlled superiority trial has four parallel groups and 1:1:1:1 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 or 8mg of preservative free dexamethasone either intravenous or perineural. The remainder of the intraoperative and postoperative care is at the discretion of the attending anesthesiologist and surgeon. Based on previous work, with 70 patients per group, the study is at least 90% powered to detect a 3 hour difference in analgesia for dose or route, and a 4 hour synergistic interaction, even with a 5% attrition rate. Outcomes will be assessed by chart review and telephone follow up on postoperative day one, postoperative day 2 (if necessary), and postoperative day 14.
An interim analysis of group standard deviations only will occur after 100 patients have completed the study to determine if the original power calculations were accurate, and if testing for the interaction effect is feasible within the planned sample size of 280 participants. If testing for the interaction of dose and route is not feasible, a new study sample size will be determined, based on the number of participants needed to have 90% power to test the two main effects.
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" inter scalene 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 inter scalene block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose intravenous dexamethasone | Active comparator | Drug: Dexamethasone, Drug: Bupivacaine, Procedure: Interscalene brachial plexus block4 milligrams dexamethasone administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block |
| High dose intravenous dexamethasone | Active comparator | Drug: Dexamethasone, Drug: Bupivacaine, Procedure: Interscalene brachial plexus block8 milligrams dexamethasone administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block |
| Low dose perineurial dexamethasone | Active comparator | Drug: Dexamethasone, Drug: Bupivacaine, Procedure: Interscalene brachial plexus block4 milligrams dexamethasone administered once perineurally with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block |
| High dose perineurial dexamethasone | Active comparator | Drug: Dexamethasone, Drug: Bupivacaine, Procedure: Interscalene brachial plexus block8 milligrams dexamethasone administered once perineurally with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elective ambulatory surgery patients undergoing arthroscopic shoulder surgery
- Including rotator cuff repair
- Stabilization procedures
- Acromioplasty
- Debridement and distal clavicle excision
Key exclusion criteria (17 listed)
- Patient refusal, diabetes
- Pregnancy
- Coagulopathy significant enough to be a contraindication to regional anesthesia as determined by the attending anesthesiologist
- Sensitivity to local anesthetics or dexamethasone
- Severe chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone | Drug | High dose intravenous dexamethasone, High dose perineurial dexamethasone, Low dose intravenous dexamethasone, Low dose perineurial dexamethasone |
| Bupivacaine | Drug | High dose intravenous dexamethasone, High dose perineurial dexamethasone, Low dose intravenous dexamethasone, Low dose perineurial dexamethasone |
| Interscalene brachial plexus blockPerformed with real time ultrasound guidance. | Procedure or surgery | High dose intravenous dexamethasone, High dose perineurial dexamethasone, Low dose intravenous dexamethasone, Low dose perineurial dexamethasone |
Primary outcome
Duration of analgesia after interscalene block
Time frame: Time-to-event outcome measure, assessed up to the end of postoperative day 2 (approximately 60 hours from performance of the block).
Time from block performance to the first time shoulder pain was experienced after the surgery, rounded to the nearest 0.1 hours, as reported by the participant at telephone follow-up on postoperative day one, or if necessary, postoperative day 2.
14 secondary outcomes
Block Success or Failure
Time frame: Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after the performance of the block.
Severity of pain at the time the primary outcome occurred, measured on an 11-point numerical rating score.
Time frame: Assessed at the time that the primary outcome occurs, an expected average of 20 hours after performance of the block.
Cumulative Analgesic Consumption in the post anesthesia care unit, measured as equivalent milligrams of morphine.
Time frame: "Change" outcome measure: From admission to the post anesthesia care unit (an expected average of 3 hours after performance of the block), to discharge from the post anesthesia care unit (an expected average of 5 hours after performance of the block).
Cumulative Analgesic Consumption from post anesthesia care unit discharge until the time the primary outcome occurred, measured as equivalent milligrams of morphine.
Time frame: "Change" outcome measure: From discharge from the post anesthesia care unit (an expected average of 5 hours after performance of the block), to the occurrence of the primary outcome (an expected average of 20 hours after performance of the block).
Postoperative Nausea and/or vomiting measured on an 11-point numerical rating score.
Time frame: Assessed at telephone follow up on postoperative day one.
First postoperative night Sleep Quality, measured on an 11-point numerical rating score.
Time frame: Assessed at telephone follow up on postoperative day one.
Observed postoperative Dyspnea, as recorded in the post anesthesia care unit record.
Time frame: Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after performance of the block.
Subjective postoperative Dyspnea, measured on an 11-point numerical rating score.
Time frame: Assessed at telephone follow up on postoperative day one.
Restlessness and/or Anxiety, measured on an 11-point numerical rating score.
Time frame: Assessed at telephone follow up on postoperative day one.
Motor and/or Sensory Block Dissatisfaction, measured on an 11-point numerical rating score.
Time frame: Assessed at telephone follow up on postoperative day one
Likelihood of choosing this method of analgesia again, measured on an 11-point numerical rating score.
Time frame: Assessed at telephone follow up on postoperative day one
Unplanned Postoperative Hospital Admission, as reported at telephone follow up or chart review.
Time frame: Assessed at telephone follow up and chart review on postoperative day one.
New Persistent Neurologic Symptoms
Time frame: Assessed at postoperative day 14.
Post anesthesia care unit length of stay in minutes
Time frame: Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after performance of the block.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Background: PubMed 9717590Fortier J, Chung F, Su J. Unanticipated admission after ambulatory surgery--a prospective study. Can J Anaesth. 1998 Jul;45(7):612-9. doi: 10.1007/BF03012088.
- Background: PubMed 23864181Hughes MS, Matava MJ, Wright RW, Brophy RH, Smith MV. Interscalene brachial plexus block for arthroscopic shoulder surgery: a systematic review. J Bone Joint Surg Am. 2013 Jul 17;95(14):1318-24. doi: 10.2106/JBJS.L.01116. No abstract available.
- Background: PubMed 20565394Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
- Background: PubMed 11811241Wu CL, Rouse LM, Chen JM, Miller RJ. Comparison of postoperative pain in patients receiving interscalene block or general anesthesia for shoulder surgery. Orthopedics. 2002 Jan;25(1):45-8. doi: 10.3928/0147-7447-20020101-15.
- Background: PubMed 12491559Boezaart AP. Continuous interscalene block for ambulatory shoulder surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):295-310. doi: 10.1053/bean.2002.0239.
- Background: PubMed 24413428Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.
- Background: PubMed 24534592Bailard NS, Ortiz J, Flores RA. Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations, and recommendations. Am J Health Syst Pharm. 2014 Mar 1;71(5):373-85. doi: 10.2146/ajhp130336.
- Background: PubMed 21956081Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.
- Background: PubMed 20009936Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
- Background: PubMed 21676892Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.
- Background: PubMed 21681533Tandoc MN, Fan L, Kolesnikov S, Kruglov A, Nader ND. Adjuvant dexamethasone with bupivacaine prolongs the duration of interscalene block: a prospective randomized trial. J Anesth. 2011 Oct;25(5):704-9. doi: 10.1007/s00540-011-1180-x. Epub 2011 Jun 17.
- Background: PubMed 22379567Kim YJ, Lee GY, Kim DY, Kim CH, Baik HJ, Heo S. Dexamathasone added to levobupivacaine improves postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Feb;62(2):130-4. doi: 10.4097/kjae.2012.62.2.130. Epub 2012 Feb 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C Mutter, MD MSc principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Bupivacaine and Interscalene brachial plexus block in people with Pain, Postoperative and Disorder of Shoulder, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia after interscalene block (time frame: Time-to-event outcome measure, assessed up to the end of postoperative day 2 (approximately 60 hours from performance of the block).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02426736, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.