Plain English Summary
Background and study aims
Pain after surgery occurs in four out of every five patients and is a major public health concern. The goal of this pilot study is to evaluate if a larger randomized controlled trial (RCT) addressing pain management after surgery is possible. Other objectives are to: 1) identify solutions to challenges that may arise in conducting the study, and 2) obtain some data to determine how many patients will be needed for the larger RCT. We chose to study patients undergoing shoulder surgery since it is a common surgery associated with fairly severe pain that is poorly controlled with current opioid-based regimens.
Who can participate?
Adults who are 18 years or older and having shoulder surgery for rotator cuff injury or shoulder instability.
What does the study involve?
The study involves receiving one of three treatments that are routinely used at the participating hospitals. Patients will be randomized to receive: 1) a combination of pain medications before surgery, 2) a nerve block, or 3) a combination of pain medications before surgery plus the nerve block.
What are the possible benefits and risks of participating?
We cannot guarantee that there is any personal benefit to participating in the study, i.e. that one treatment is better than the other. However, participants will have the opportunity to contribute to research in pain management. As all the study interventions are routinely used at the participating sites, the risks of this study are the same as the risks assumed when undergoing this surgery without participating in the study. We have reduced some risk by excluding people who are unlikely to benefit or at high risk of certain adverse events.
Where is the study run from?
This study is being coordinated from the Jewish General Hospital in Montreal, Quebec, Canada.
When is the study starting and how long is it expected to run for?
Recruitment for this study is expected to begin in February 2019, and will continue until the target sample size is reached. The study will conclude in March 2020.
Who is funding the study?
This study is funded by the Canadian Institutes of Health Research.
Who is the main contact?
Dr. Ana Velly
ana.velly@mcgill.ca
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ana Velly
ORCID ID
http://orcid.org/0000-0003-3125-1884
Contact details
3755 Cote Ste Catherine
Suite A.017
Montreal
H3T1E2
Canada
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PJT-156259
Study information
Scientific title
Optimizing pain management: a pilot randomized trial in patients undergoing arthroscopic shoulder surgery
Acronym
N/A
Study hypothesis
This trial is an exploratory pilot study to test the feasibility for a future pragmatic trial – this is the primary outcome. We are collecting pilot data on the interventions on post-operative pain only as a secondary outcome, and preliminary data suggests that PMC may reduce pain intensity at 24 hours post-surgery, and possibly reduce routine opioid use as compared to PMC+Block. Therefore, the hypotheses are:
Primary hypothesis: The future pragmatic RCT is feasible.
Primary hypothesis for the future definitive RCT: PMC will reduce pain intensity at 24 hours post-surgery compared to either PMC+Block or Block alone; and will reduce the need for rescue opioid medication.
Ethics approval
The Jewish General Hospital's (WCMH) Ethics Review Board, 11/12/2018, ref. MP-05-2019-1505 - approval pending
Study design
Interventional, pilot randomised parallel trial.
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Rotator cuff pathology or shoulder instability
Intervention
Consenting patients will be randomly assigned to receive one of three study interventions: PMC, Block, or PMC+Block.
PMC Group:
Pregabalin: 25mg at night on the 5th day prior to surgery, 25mg BID on the 4th day prior to surgery, 50 mg BID on the 3rd day prior to surgery, 75 mg BID on 2nd and 1st day prior to surgery. In our pilot data (Section 3.5), 75 mg BID appeared effective and it is less likely to create adverse events. If patients do not tolerate the 75mg dose (e.g. sedation), we will use the greatest tolerable dose.
Non-steroidal anti-inflammatory drugs: Celecoxib 100 mg PO BID starting 5 days prior to surgery. In case of contra-indication or intolerance, Naproxen EC 500 mg PO BID for 5 days will be used.
Block Group:
Interscalene Block. An anesthesiologist experienced in providing nerve blocks will administer a preoperative single shot interscalene block, approximately 1 hour prior to the start of surgery. Either ropivacaine or bupivacaine in a volume of 5-15 ml, and a concentration of 0.5%, with no adjuvants will be used. We will not use continuous interscalene block due to logistical challenges.
Duration of the treatment.
For the PMC and PMC+Block groups, they will receive the PMC 5 days prior to their surgery date. The duration of treatment for these groups is thus 5 days. The Block group will receive their treatment right before their surgery – duration of treatment is therefore 1 day. Following that, all groups will receive the same, standard postoperative treatment. All participants will have their last follow-up assessment performed at 6 months post-surgery. The time points for follow-ups are at 6 hours, 24 hours, 7 days, 2 and 6 months post-surgery.
Randomization.
We will apply stratified randomization of patients by surgeon using random number generation by an independent third party. To improve blinding, distinct evaluators will be making assessments. A research assistant will assess POP intensity and research nurses will assess pain medication and adverse events. Further, we will ask patients not to disclose their treatment. However, we recognize that the evaluators may be unblinded if patients disclose their treatment (see Section 7.1). We will also blind the supervising statistician to prevent biases during the analysis (e.g., model selection, handling of missing data).
Wash-out period.
There is no wash-out period in this parallel RCT, and there are 3 treatment groups.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
1. Recruitment and consent: Recruitment rate will be assessed as the number of eligible participants who consent to participate in the study, by month, every month. If patient recruitment is below 25% early in the process, we will develop methods to improve recruitment decreasing the barriers to recruitment.
2. Treatment allocation randomization, blinding: Problems will be summarized through internal communications. We will assess evaluator unblinding after the trial, and whether it was caused by study processes (solutions would be implemented during the pilot trial), active treatment efficacy or adverse events.
3. Adherence: We will document challenges and the proposed solutions with all participating surgeons through internal communications. Adherence rate will be calculated by number of participants who adhered at least 50% of the medication as prescribed 5 days before surgery divided by the total of participants who received the prescribed medication (PMC and PMC+Block groups). If we cannot increase adherence (defined as taking at least 50% of the medication as prescribed 5 days before surgery) to occur in at least 75% of participants, we will consider the definitive trial to be non-feasible.
4. Attrition: Attrition rates will be assessed by the number of patients who consent to participate who remain in the study until the end of the follow-up period. We will assess dropout during the study. We will document challenges and the proposed solutions with all dropouts through internal communications. We consider a dropout rate of ≤ 20% to be the threshold for a feasible future definitive RCT.
5. Response rates to questionnaires and incomplete questionnaires: We will consider 80% as an acceptable threshold. We will ask all non-responders why they did not to respond the questionnaire or the question, and use this information to decide how to improve response rates.
6. Time needed to collect data. We will record how long each set of questionnaires requires, and elicit feedback as to its acceptability. If more than 25% of patients consider the time unacceptable, the definitive RCT will focus on the most important data.
Secondary outcome measures
1. Cumulative consumption of opioids for pain management. The research nurse/assistant will assess if patients use opioids at 6 h, 1 day, and 1 week after surgery during their follow-ups at these time points.
2. Pain intensity at 1 day post-surgery. This is generally the primary outcome in trials assessing the effectiveness of POP management. We will measure POP intensity using the standardized, validated questionnaire recommended by the APS: “Patient Outcome questionnaire”(POQ).
3. Pain intensity. We will also assess pain intensity at 6 h, 1 week, 2 and 6 months post-surgery using the POQ as above.
4. Supplemental pain management. We will assess if patients received non-opioid supplemental pain management (rescue medication, other treatments) during follow-ups at 6 h, 1 day, 1 week, and 2 and 6 months after surgery, and identify the treatments received. The research nurse/assistant will be responsible for this.
5. Physical Activity. We will use the validated self-assessment portion of the POQ. This questionnaire will be used at 2 and 6 months post-surgery.
6. Frequency of adverse and serious adverse events: Adverse and serious adverse events will be recorded by the research nurse/assistant at 6h, 1 day, and 7 days post-surgery. In addition, the research nurse/assistant will contact the study surgeons weekly to assess any occurrence of serious adverse events.
7. Cost data. We will record the cost of the anesthesiologist’s time, miscellaneous items (e.g., syringes, gauze pads), and medications by region (Ontario and Quebec).
Overall trial start date
01/04/2018
Overall trial end date
31/03/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or older
2. Understand English or French;
3. Undergoing arthroscopic surgery for shoulder rotator cuff pathology or shoulder instability with at least 6 months of symptoms.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
36
Participant exclusion criteria
1. True allergies or other contraindications to any of the medications used in the study
2. Bleeding disorders
3. History of ulcers
4. History of cancer
5. Life expectancy for less than one year
6. Current use of high-dose opioids (>60 mg equivalents of morphine), gabapentinoids, antidepressants, antipsychotics, or cannabinoids;
7. Patients with chronic pulmonary lung disease (COPD)
Recruitment start date
15/02/2019
Recruitment end date
15/08/2019
Locations
Countries of recruitment
Canada
Trial participating centre
Jewish General Hospital
3755 Cote Ste Catherine
Montreal
H3T1E2
Canada
Trial participating centre
Maisonneuve-Rosemont Hospital
5415 Assumption Blvd
Montreal
H1T 2M4
Canada
Trial participating centre
St. Mary's Hospital
3830 Avenue Lacombe
Montréal
H3T 1M5
Canada
Trial participating centre
St. Joseph's Health Care London
268 Grosvenor St
London
N6A 4V2
Canada
Sponsor information
Organisation
Canadian Institutes of Health Research
Sponsor details
CIHR Institute of Musculoskeletal Health and Arthritis
University of British Columbia
Robert HN Ho Research Centre
7th Floor – 2635 Laurel Street
Vancouver
V5Z 1M9
Canada
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Canadian Institutes of Health Research
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR, IRSC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Results and Publications
Publication and dissemination plan
As this is a pilot study, we will publish our results in peer reviewed journals, but will refrain from conducting a knowledge translation program to clinicians. For the definitive trial, we will disseminate the results through the research team’s involvement with relevant organizations such as the Quebec Pain Research Network, the Alan Edwards Centre for Research on Pain, and the Canadian Pain Society, who in turn will collaborate and share information with patients’ pain groups such as the Canadian Pain Coalition and “Association québécoise de la douleur chronique”. The recommendations of the “Moving knowledge to action through dissemination and exchange” by Michelle L. Gagnon will be followed.
IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/01/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list