Abstract
ABSTRACTBackground: Clinical trials remain vital in order to: A) develop new treatment interventions, and also, B) to guide optimal use of current interventions for the treatment and prevention of acute and chronic postsurgical pain. Measures of pain (e.g. intensity and relief) and opioid use have been validated for the settings of postsurgical pain and continue to effectively guide research in this field..Methods: This narrative review considers needs for innovation in postsurgical pain trial outcomes assessment.Results: Future improvements are needed and include: A) more widespread measurement of movement-evoked pain with validation of various procedure-relevant movemen-tevoked pain maneuvers; B) new validated analytical approaches to integrate early postoperative pain scores with opioid use; and, C) closer attention to the measurement of postoperative opioid use after hospital discharge. In addition to these traditional measures, consideration is being given to the use of new pain-relevant outcome domains that include: 1) other symptoms (e.g. nausea and vomiting), 2) recovery of physiological function (e.g. respiratory, gastrointestinal, genitourinary and musculoskeletal), 3) emotional function (e.g. depression, anxiety) and, 4) development of chronic postsurgical pain. Also, there is a need to develop pain-related domains and measures for evaluating both acute and chronic post-operative pain. Finally, evidence suggests that further needs for improvements in safety assessment and reporting in postsurgical pain trials is needed, e.g. by using an agreed upon, standardized collection of outcomes that will be reported as a minimum in all postsurgical pain trials.Conclusions: These proposed advances in outcome measurement methodology are expected to improve the success by which postsurgical pain trials guide improvements in clinical care and patient outcomes.
Highlights
IntroductionOver 300 million surgical procedures are done in the world each year[1] and approximately 60–70% of these are associated with moderate or severe postsurgical pain.[2–4] The clinical goals for acute postsurgical pain management include the relief of pain-related suffering, and the reduction of pain-related physiological impairment (e.g. immobility, impaired cardio-respiratory, gastrointestinal and cognitive function, disturbed sleep) in order to accelerate functional recovery after surgery.[5,6] In addition to reducing the severity and adverse effects of postsurgical pain in the days to weeks after surgery, development of chronic postsurgical pain that persists beyond 3 months after surgery has been increasingly recognized as a serious complication that requires greater attention by surgeons, anesthesiologists and other perioperative healthcare providers and researchers.[7–10]
The clinical goals for acute postsurgical pain management include the relief of pain-related suffering, and the reduction of pain-related physiological impairment in order to accelerate functional recovery after surgery.[5,6]
In addition to reducing the severity and adverse effects of postsurgical pain in the days to weeks after surgery, development of chronic postsurgical pain that persists beyond 3 months after surgery has been increasingly recognized as a serious complication that requires greater attention by surgeons, anesthesiologists and other perioperative healthcare providers and researchers.[7–10]
Summary
Over 300 million surgical procedures are done in the world each year[1] and approximately 60–70% of these are associated with moderate or severe postsurgical pain.[2–4] The clinical goals for acute postsurgical pain management include the relief of pain-related suffering, and the reduction of pain-related physiological impairment (e.g. immobility, impaired cardio-respiratory, gastrointestinal and cognitive function, disturbed sleep) in order to accelerate functional recovery after surgery.[5,6] In addition to reducing the severity and adverse effects of postsurgical pain in the days to weeks after surgery, development of chronic postsurgical pain that persists beyond 3 months after surgery has been increasingly recognized as a serious complication that requires greater attention by surgeons, anesthesiologists and other perioperative healthcare providers and researchers.[7–10]. Proof-of-concept study designs in trials evaluating novel therapies for postsurgical pain – typically in comparison with inert placebo – generally emphasize trial feasibility, singledose trial designs, high assay sensitivity (i.e. ability of the trial to demonstrate a treatment versus placebo difference if one exists) and internal validity.[12–14] In such trials – that typically evaluate novel analgesics that have shown efficacy in reducing nociception in preclinical animal models – primary outcome measurement is usually focused on pain intensity or relief.[14]. Oriented study designs of trials focused on optimizing clinical outcomes – often involving currently available pain treatments – generally emphasize generalizability, clinical relevance and importance, and often involve multi-dose trial designs.[11,15] In such trials, that typically involve various domains of clinical assessment, outcome measures in addition to pain should whenever possible be included, addressing domains such as physiological function, patient satisfaction and time to hospital discharge readiness.[11]. In a meta-analysis of clinical trials of drugs studied for the prevention of chronic pain after
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