MP55-08 LIPOSOMAL BUPIVACAINE LOCAL INFILTRATION FOR BUCCAL MUCOSAL GRAFT HARVEST SITE PAIN CONTROL: A SINGLE- BLIND RANDOMIZED CONTROLLED TRIAL

Abstract Background Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. Methods This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. Discussion The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. Trial registration The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250).

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Correction to: Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04474-4 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

◽

Aaron Gazendam ◽

Seper Ekhtiari ◽

Nolan S. Horner ◽

Nicole Simunovic ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Pain Control ◽

Controlled Trial ◽

Standard Of Care ◽

Shoulder Surgery ◽

Opioid Prescription ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Arthroscopic Knee

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Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04168-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Shicheng Wang ◽

Wensheng Wang ◽

Long Shao ◽

Jing Ling

Keyword(s):

Clinical Trial ◽

Total Knee Arthroplasty ◽

Randomized Controlled Trial ◽

Pain Control ◽

Controlled Trial ◽

Control Group ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Total Knee ◽

Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

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