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 .
Postoperative Analgesia After Major Spine Surgery: Patient-Controlled Epidural Analgesia Versus Patient-Controlled Intravenous Analgesia
BACKGROUND : Spinal fusion surgery causes severe postoperative pain , hampering reconvalescense . We investigated the efficacy of patient-controlled epidural analgesia ( PCEA ) in a prospect i ve , double-blind , r and omized , controlled comparison with patient-controlled IV analgesia ( PCIA ) . METHODS : After lumbar anterior-posterior fusion receiving an epidural catheter intraoperatively , 72 patients were given either PCEA ( ropivacaine 0.125 % and sufentanil 1.0 & mgr;g/mL at 14 mL/h ; bolus : 5 mL ; lockout time : 15 min ) and IV placebo or PCIA ( morphine 2.0 mg/mL ; bolus : 3 mg ; lockout time : 15 min ) and epidural placebo .  Pain levels ( visual analog scale 0 - 10 ) , functional capabilities ( turning in bed , st and ing , and walking ) , analgesic consumption , and side effects were evaluated until 72 h after surgery . RESULTS : Fourteen patients were excluded by predetermined criteria , leaving 58 patients for data analysis . Pain levels at rest and during mobilization were significantly lower in the PCEA when compared with that in the PCIA group throughout the study period ( P < 0.0001 in all cases ) . Time until able to turn in bed was achieved earlier in the PCEA group ( P < 0.05 ) . Patients in the PCEA group were significantly more satisfied with pain therapy ( P < 0.01 ) . CONCLUSION : We conclude that PCEA with ropivacaine and sufentanil , using intraoperatively placed epidural catheters , provides superior analgesia and higher patient satisfaction when compared with PCIA after spinal fusion surgery
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 .