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 .
Premedication with Gabapentin: The Effect on Tourniquet Pain and Quality of Intravenous Regional Anesthesia
BACKGROUND : Gabapentin , an oral non-opioid analgesic , has been used to decrease pain after a variety of surgical procedures . We hypothesized that premedication with gabapentin would minimize tourniquet-related pain in patients receiving IV regional anesthesia ( IVRA ) . METHODS : Patients undergoing elective h and surgery with IVRA were r and omly assigned to one of two study groups using a double-blind study design . The control group ( n = 20 ) received placebo capsules 1 h before the surgery , and the gabapentin  group ( n = 20 ) received gabapentin 1.2 g p.o . before the operation . IVRA was achieved in all patients with lidocaine , 3 mg/kg , diluted with saline to a total volume of 40 mL. Fentanyl , 0.5 & mgr;g/kg IV , was administered as a rescue analgesic during surgery . Sensory and motor block onset and recovery times , tourniquet pain , and quality of anesthesia were assessed at specific time intervals during the perioperative period . Visual analog scale pain scores ( 0–10 ) were recorded during the 24 h follow-up period , and patients received diclofenac , 75 mg IM , if their pain score was > 4 . RESULTS : The onset of the sensory and motor block did not differ between the two study groups . However , tourniquet pain scores at 30 , 40 , 50 , and 60 min after cuff inflation were lower in the gabapentin group ( P < 0.05 ) . The time to intraoperative analgesic rescue was prolonged in the gabapentin group ( 35 ± 10 min vs 21 ± 13 min , P < 0.05 ) , and less supplemental fentanyl was required ( 35 ± 47 & mgr;g vs 83 ± 73 & mgr;g , P < 0.05 ) . The quality of anesthesia , as independently assessed by the anesthesiologist and the surgeon , was significantly better in the gabapentin ( versus control ) group . In the gabapentin group , the time to requesting a rescue analgesic after surgery was prolonged ( 135 ± 25 min vs 85 ± 19 min , P < 0.05 ) , and postoperative pain scores at 60 min ( 3.8 ± 0.9 vs 2.2 ± 0.5 ) and 120 min ( 3.2 ± 1.4 vs 1.8 ± 0.8 ) , as well as diclofenac consumption ( 30 ± 38 mg vs 60 ± 63 mg ) , were reduced after surgery . CONCLUSIONS : Premedication with oral gabapentin ( 1.2 g ) decreased tourniquet-related pain and improved the quality of anesthesia during h and surgery under IVRA . Gabapentin also reduced pain scores in the early postoperative period
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 .