RESUMO
BACKGROUND: Colorectal resections are associated with a pronounced inflammatory response, severe postoperative pain, and postoperative ileus. The aim of this study was to evaluate the main effects of lidocaine and ketamine, and their interaction in colorectal cancer (CRC) patients after open surgery. The interaction could be additive if the effect of 2 drugs given in combination equals the sum of their individual effects, or multiplicative if their combined effect exceeds the sum of their individual effects. We hypothesized that the combination of lidocaine and ketamine might reduce the inflammatory response additively or synergistically. METHODS: Eighty-two patients undergoing elective open colorectal resection were randomized to receive either lidocaine or placebo and either ketamine or placebo in a 2 × 2 factorial design. After induction of general anesthesia, all subjects received an intravenous bolus (lidocaine 1.5 mg/kg and/or ketamine 0.5 mg/kg and/or a matched saline volume) followed by a continuous infusion (lidocaine 2 mg·kg-1·h-1 and/or ketamine 0.2 mg·kg-1·h-1 and/or a matched saline volume) until the end of surgery. Primary outcomes were serum levels of white blood cell (WBC) count, interleukins (IL-6, IL-8), and C-reactive protein (CRP) measured at 2 time points: 12 and 36 hours after surgery. Secondary outcomes included intraoperative opioid consumption; visual analog scale (VAS) pain scores at 2, 4, 12, 24, 36, and 48 hours postoperatively; cumulative analgesic consumption within 48 hours after surgery; and time to first bowel movement. We assessed the main effects of each of lidocaine and ketamine and their interaction on the primary outcomes using linear regression analyses. A Bonferroni-adjusted significance level was set at .05/8 = .00625 for primary analyses. RESULTS: No statistically significant differences were observed with either lidocaine or ketamine intervention in any of the measured inflammatory markers. No multiplicative interaction between the 2 treatments was confirmed at 12 or 36 hours after surgery: WBC count, P = .870 and P = .393, respectively; IL-6, P = .892 and P = .343, respectively; IL-8, P = .999 and P = .996, respectively; and CRP, P = .014 and P = .445, respectively. With regard to inflammatory parameters, no evidence of additive interactions was found. Lidocaine and ketamine, either together or alone, significantly reduced intraoperative opioid consumption versus placebo, and, except for lidocaine alone, improved pain scores. Neither intervention significantly influenced gut motility. CONCLUSIONS: Our study results do not support the use of an intraoperative combination of lidocaine and ketamine in patients undergoing open surgery for CRC.
RESUMO
The goal of the trial was to examine the effects of adding electromyographic biofeedback (EMG-BF) to the conventional program of physiotherapy after total hip arthroplasty (THA) on functional recovery and quality of life. The trial was designed as a prospective, interventional, single-blinded randomized controlled study. Ninety patients were randomized into an experimental group (EG) (n = 45; mean age 63.9 ± 8.8) and control group (CG) (n = 45; mean age 63.9 ± 9). All patients received 21 days of physiotherapy which consisted of therapeutic exercise (land-based and aquatic), electrotherapy, and education. Electromyographic biofeedback was added to a portion of the land-based exercise in EG. The Hip Disability and Osteoarthritis Outcome Score (HOOS), Numeric Rating Scale (NRS), Short Form Health Survey-36 (SF-36), use of a walking aid, 30 s chair stand test (CST) as well as the Timed Up and Go (TUG) test were used for outcome measurement. A higher proportion of the participants in both groups did not need a walking aid after the intervention (p < 0.05). All participants improved their 30 s CST and TUG results (p < 0.001), as well as their NRS and HOOS scores (p < 0.05). No significant differences between the groups were found. There were no additional benefits from adding EMG-BF to the conventional physiotherapy protocol.