Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .
Continuous infusion of local anesthetic at iliac crest bone-graft sites for postoperative pain relief. A randomized, double-blind study.
BACKGROUND Autologous bone graft is the so-called gold st and ard for reconstruction of bone defects and nonunions . The most frequent complication is donor site pain . The iliac crest is a common source for autologous bone graft . The purpose of this study was to determine whether a continuous infusion of 0.5 % bupivacaine into the iliac crest harvest site provides pain relief that is superior to the relief provided by systemic narcotic pain medication alone in patients undergoing reconstructive orthopaedic trauma procedures . METHODS A prospect i ve , double-blind r and omized study of patients over eighteen years of age who were undergoing harvesting of iliac crest bone graft was conducted . The patients were r and omized to the treatment arm ( bupivacaine infusion pump ) or the placebo arm . Postoperatively , all study patients received morphine sulfate with use of a patient-controlled analgesia pump . The patients recorded the pain at the donor and recipient sites with use of a scale ranging from 0 to 10 . The use of systemic narcotic medication was recorded . Independent- sample s t tests were used to assess differences in perceived pain relief between the treatment and control groups at zero , eight , sixteen , twenty-four , thirty-two , forty , and forty-eight hours after surgery . Pain was also assessed at two and six weeks postoperatively . RESULTS Sixty patients were enrolled . Across all data points , except pain at the recipient site at twenty-four hours , no significant differences in the perception of pain were found between the bupivacaine group and the placebo group . On the average , patients in the treatment group reported more pain than those in the control group . No significant difference was found between the two groups with regard to the amount of narcotic medication used . CONCLUSIONS No difference in perceived pain was found between the groups . The results of this small , unstratified study indicate that continuous infusion of bupivacaine at iliac crest bone-graft sites during the postoperative period is not an effective pain-control measure in hospitalized patients receiving systemic narcotic medication
Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .