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Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 103 - 103
1 May 2017
Kaya A Ömer Ü Oğuz PŞ Bahattin K Samet E Burak Ö
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Background. Osteoarthritis (OA) pain treatment has limitations in terms of serious adverse effects and low efficacy. We aimed to evaluate efficacy and safety of naproxen sodium/codeine phosphate combination in these patients. Methods. In this prospective, randomised, double blind, placebo controlled clinical trial, 135 patients with osteoarthritis, who were 40–65 years; applied to our institution's orthopaedics outpatient clinic; had grade 1, 2, or 3 primary osteoarthritis diagnosed in last 1 year; and had Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score≥40, and Visual Analogue Scale score≥40, were enrolled. Subjects were randomised (1:1) to placebo (n= 67) or combination (n= 68) arms, in which 550 mg naproxen sodium/30mg codeine phosphate was given orally twice a day for 7 days. Rescue medicine was 500 mg paracetamol (max= 6 tablets/day). Demographic characteristics, medical history, adverse events, VAS and WOMAC scores were collected in study visits performed within 10 days. The study was approved by local institutional ethics committee and written informed consents were obtained from all participants. Results. Patients were evenly matched in both arms. The mean age was 52.3±6.6 years (89.7% female). WOMAC and VAS scores decreased significantly within each group (p<0.001 for all). For the study group (n=43) the mean (+ SD) and median (min-max) VAS Score was −29.8 (+21.0) and −30 (−70−0), respectively. In contrast, for the control group (n=36) the mean and median (min-max) VAS Score was −16.1 (+24.4) and −12.5 (−65−40), respectively. WOMAC score was decreased more in combination group (p= 0.044). Changes in VAS scores between visits were significantly different (more in combination receivers) between groups (p= 0.018). Ratio of patients requiring no rescue medicine was higher among combination receivers than controls (64.8% vs. 35.2%, respectively). Most common adverse events were constipation, dyspepsia, and somnolence; no fatality was encountered. Conclusions. Naproxen sodium/codeine phosphate combination is effective and safe in osteoarthritis patients. Level of Evidence. Level 1


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 279 - 279
1 May 2010
Moghtadaei M Akbarian E Farahini H Zangi M Pazouki M
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Background: Polymethylmethacrylate (PMMA) is a potent stimulant of inflammatory response. This study investigated the role of Prostaglandin E2 (PGE2), Platelet activating factor (PAF) and histamine and their specific antagonists in bone changes. Materials: 120 white-male-wistar rats were divided into ten groups. Using sterile technique, a 2mm drill hole was made in the tibia 1cm distal to the knee joint bilaterally. The left tibia was filled with Simplex particulate cement polymer (PMMA) and the right tibia was used as control. The first nine groups respectively received terfenadine 1mg/kg, 10mg/kg and 25mg/kg, alprazolam 0.08mg/kg, 0.32mg/kg and 0.64mg/kg, and naproxen 1mg/kg, 5mg/kg and 25mg/kg; however, the tenth group received no drug and served as control. The animals were killed after 16 weeks and implant areas were harvested aseptically and studied by one pathologist. Results: Our study revealed that the cellular reaction in the left side was statistically more than the right one in all cases (p< 0.05). Also, a significant decrease in histiocytes and giant cells was seen just in those groups that had received 10mg/kg and 25mg/kg of terfenadine, 0.32mg/kg and 0.64mg/kg of alprazolam and 5mg/kg and 25mg/kg of naproxen (P< 0.05) while administration of 1mg/kg naproxen resulted in significant decrease only in giant cells (P< 0.05) but not in histiocytes. Discussion: Previous studies have suggested that particulate debris, PGE2 production and inflammatory response are associated with arthroplasty loosening. This experiment has demonstrated that the increased cellular reaction by the membrane surrounding particulate cement polymer can be suppressed by administration of PGE2, PAF and histamine specific inhibitors. The use of these agents may be indicated in retarding the bone loss associated with early prosthetic loosening


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Hallux valgus surgery can result in moderate to severe post-operative pain requiring the use of narcotic medication. The percutaneous distal metatarsal osteotomy is a minimally invasive approach which offers many advantages including minimal scarring, immediate weight bearing and decreased post-operative pain. The goal of this study is to determine whether the use of narcotics can be eliminated using an approach combining multimodal analgesia, ankle block anesthesia and a minimally invasive surgical approach. Following ethics board approval, a total of 160 ambulatory patients between the ages of 18-70 with BMI ≤ 40 undergoing percutaneous hallux valgus surgery are to be recruited and randomized into Narcotic-free (NF) or Standard (S) groups. To date, 72 patients have been recruited (38 NF and 34 S). The NF group received acetaminophen, naproxen, pregabalin 75mg and 100mg Ralivia (tramadol extended release) before surgery and acetaminophen, naproxen, pregabalin 150mg one dose and Ralivia 100mg BID for five days, as well as a rescue narcotic (hydromorphone, 1mg pills) after surgery. The S group received acetaminophen and naproxen prior to surgery and acetaminophen, naproxen and hydromorphone (1mg pills) post-operatively, our current standard. Visual analog scales (VAS) were used to assess pain and narcotic consumption was recorded at 6, 12, 24, 36, 48, 72 hours and seven days post-operatively. Patients wore a smart watch to record the number of daily steps and sleep hours. A two-sided t-test was used to compare the VAS scores and narcotic consumption. During the first post-operative week, the NF group consumed in total an average of 6.5 pills while the S group consumed in total an average of 16 pills and this difference was statistically significant (p-value=0.001). Importantly, 19 patients (50%) in the NF group and four patients (12%) in the S group did not consume any narcotics post-operatively. For the VAS scores at 24, 48, 72 hours and seven days the NF group's average scores were 2.17, 3.17, 2.92, 2.06 respectively and the S group's average scores were 3.97, 4.2, 3.23, 1.97. There was a statistically significant difference between the groups at 24 and 48hours (the NF group scored lower on the VAS) with a p-value of 0.0008 and 0.04 respectively, but this difference is not considered clinically significant as the minimal clinically important difference reported in the literature is a two-point differential. The NF group walked an average of 1985.75 steps/day and slept an average of 8h01 minute/night, while the S group walked an average of 1898.26 steps/day and slept an average of 8h26 minutes/night in the first post-operative week. Hallux valgus remains a common orthopedic foot problem for which surgical treatment results in moderate to severe post-operative pain. This study demonstrates that with the use of multimodal analgesia, ultrasound guided ankle blocks and a percutaneous surgical technique, narcotic requirements decreased post-operatively. The use of long-acting tramadol further decreased the need for narcotic consumption. Despite decreased use of narcotics, this combined novel approach to hallux valgus surgery allows for early mobilization and excellent pain control


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 65 - 65
1 Dec 2022
Gazendam A Ayeni OR
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Orthopaedic surgeons prescribe more opioids than any other surgical speciality. Opioids remain the analgesic of choice following arthroscopic knee and shoulder surgery. There is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients’ pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. The objective of the current randomized controlled trial (RCT) was to evaluate the efficacy of a multi-modal, opioid-sparing approach to postoperative pain management in patients undergoing arthroscopic shoulder and knee surgery. The NO PAin trial is a pragmatic, definitive RCT (NCT04566250) enrolling 200 adult patients undergoing outpatient shoulder or knee arthroscopy. Patients are randomly assigned in a 1:1 ratio to an opioid-sparing group or standard of care. The opioid-sparing group receives a three-pronged prescription package consisting of 1) a non-opioid prescription: naproxen, acetaminophen and pantoprazole, 2) a limited opioid “rescue prescription” of hydromorphone, and 3) a patient education infographic. The control group is the current standard of care as per the treating surgeon, which consists of an opioid analgesic. The primary outcome of interest is oral morphine equivalent (OME) consumption up to 6 weeks postoperatively. The secondary outcomes are postoperative pain scores, patient satisfaction, quantity of OMEs prescribed and number of opioid refills. Patients are followed at both 2 and 6 weeks postoperatively. Data analysts and outcome assessors are blinded to the treatment groups. As of December 1, 2021 we have enrolled 166 patients, reaching 83% of target enrolment. Based on the current recruitment rate, we anticipate that enrolment will be completed by the end of January 2022 with final follow-up and study close out completed by March of 2022. The final results will be released at the Canadian Orthopaedic Association Meeting in June 2022 and be presented as follows. The mean difference in OME consumption was XX (95%CI: YY-YY, p=X). The mean difference in OMEs prescribed was XX (95%CI: YY-YY, p=X). The mean difference in Visual Analogue Pain Scores (VAS) and patient satisfaction are XX (95%CI: YY-YY, p=X). The absolute difference in opioid refills was XX (95%CI: YY-YY, p=X). The results of the current study will demonstrate whether an opioid sparing approach to postoperative outpatient pain management is effective at reducing opioid consumption while adequately addressing postoperative pain in patients undergoing outpatient shoulder and knee arthroscopy. This study is novel in the field of arthroscopic surgery, and its results will help to guide appropriate postoperative analgesic management following these widely performed procedures


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 71 - 71
1 Dec 2022
Gazendam A Ekhtiari S Ayeni OR
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Orthopaedic surgeons prescribe more opioids than any other surgical speciality. Opioids remain the analgesic of choice following arthroscopic knee and shoulder surgery. There is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients’ pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. The objective of the current randomized controlled trial (RCT) was to evaluate the efficacy of a multi-modal, opioid-sparing approach to postoperative pain management in patients undergoing arthroscopic shoulder and knee surgery. The NO PAin trial is a pragmatic, definitive RCT (NCT04566250) enrolling 200 adult patients undergoing outpatient shoulder or knee arthroscopy. Patients are randomly assigned in a 1:1 ratio to an opioid-sparing group or standard of care. The opioid-sparing group receives a three-pronged prescription package consisting of 1) a non-opioid prescription: naproxen, acetaminophen and pantoprazole, 2) a limited opioid “rescue prescription” of hydromorphone, and 3) a patient education infographic. The control group is the current standard of care as per the treating surgeon, which consists of an opioid analgesic. The primary outcome of interest is oral morphine equivalent (OME) consumption up to 6 weeks postoperatively. The secondary outcomes are postoperative pain scores, patient satisfaction, quantity of OMEs prescribed and number of opioid refills. Patients are followed at both 2 and 6 weeks postoperatively. Data analysts and outcome assessors are blinded to the treatment groups. As of December 1, 2021 we have enrolled 166 patients, reaching 83% of target enrolment. Based on the current recruitment rate, we anticipate that enrolment will be completed by the end of January 2022 with final follow-up and study close out completed by March of 2022. The final results will be released at the Canadian Orthopaedic Association Meeting in June 2022 and be presented as follows. The mean difference in OME consumption was XX (95%CI: YY-YY, p=X). The mean difference in OMEs prescribed was XX (95%CI: YY-YY, p=X). The mean difference in Visual Analogue Pain Scores (VAS) and patient satisfaction are XX (95%CI: YY-YY, p=X). The absolute difference in opioid refills was XX (95%CI: YY-YY, p=X). The results of the current study will demonstrate whether an opioid sparing approach to postoperative outpatient pain management is effective at reducing opioid consumption while adequately addressing postoperative pain in patients undergoing outpatient shoulder and knee arthroscopy. This study is novel in the field of arthroscopic surgery, and its results will help to guide appropriate postoperative analgesic management following these widely performed procedures


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 17 - 17
1 Jun 2016
Saed A Aweid O Kalairajah Y
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Introduction. The mortality and serious side effects risk of both medical and surgical management of hip and knee osteoarthritis (OA) has been widely published. To date however, there are no studies comparing safety between the two treatment modalities. We aimed to systematically review the published evidence on the mortality and serious complications risk of the various treatments for hip and knee OA. Methods. We searched for studies investigating the safety of arthroplasty, arthroscopy, opioids, non-steroidal anti-inflammatory drugs (NSAIDS), and paracetamol using PubMed, Score, Cochrane, PEDRO, and Google Scholar. The phrase “osteoarthritis treatment” was searched and then combined using Boolean connectors (“OR and “AND) with “serious complications” or “serious adverse events” or “mortality”. The quality of included studies was assessed based on the approach used by the AAOS in judging the quality of treatment studies. Results. 19 studies were included in the review. Mortality risk was highest for Naproxen HR = 3 (1.9; 4.6) and lowest for total hip replacement RR = 0.7 (0.7; 0.7). Highest serious gastrointestinal complication risk was reported for diclofenac OR = 4.77 (3.94; 5.76) and lowest for total knee replacement HR = 0.6 (0.49; 0.75). Ibuprofen had the highest renal complications risk OR=2.32 (1.45; 3.71) whereas celecoxib had the lowest RR = 0.61 (0.4; 0.94). Celecoxib users had the highest cardiovascular (CV) complication risk OR=2.26 (1; 5.1) and the lowest was for tramadol RR = 1.1 (0.87; 1.4). Discussion. Long term medical management of hip and knee OA particularly with NSAIDS may carry a higher mortality risk compared to surgery. Conclusion. The practitioner and patient should carefully consider the risks of medications as well as surgery prior to commencing treatment. Treatment choice should also be tailored to the patient taking into account known GI, CVS, and renal co-morbidities