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A5 [MAY 2014, SUPPLEMENT A] Bariatric Times HOT TOPICS IN SURGICAL PAIN MANAGEMENT Additionally, a study by Petring and colleagues confirmed that significant delays in gastric emptying occur with the administration of IV opioid analgesics. When used as a gastric absorption marker, postoperative plasma concentrations of acetaminophen given orally were significantly lower than preoperative values (P<0.001) in patients who received opioids following surgery. 2 0 Analgesic Efficacy of OFIRMEV As part of an extensive clinical data set consisting of numerous randomized controlled trials (RCTs), IV acetaminophen has demonstrated a significant analgesic benefit relating to pain relief or reduction in pain intensity, and has demonstrated analgesic efficacy in a variety of surgery types. The following two pivotal studies evaluated OFIRMEV in the treatment of acute postoperative pain following abdominal laparoscopic surgery (soft tissue pain) and major orthopaedic surgery (bone and joint pain). In abdominal laparoscopic surgery, Wininger and colleagues evaluated the analgesic efficacy of repeated doses of IV acetaminophen 1g or IV placebo 100mL at six-hour intervals, or IV acetaminophen 650mg or IV placebo 65mL at four-hour intervals, over 24 hours in 244 patients with moderate to severe postoperative pain following elective laparoscopic surgery (including cholecystectomy, hysterectomy, hernia repair, colonic resection, and prostatectomy). IV or oral opioid rescue medication was available to all patients. Efficacy was measured as the weighted sum of pain intensity differences over 24 hours (SPID24) based on 100-mm visual analog scale (VAS) for the IV acetaminophen 1g versus combined placebo groups (primary endpoint); SPID24 based on VAS for the IV acetaminophen 650mg versus combined placebo groups; pain relief; patients' global evaluation of study treatment at 24 hours; time to first use of rescue medication; and total amount of rescue medication consumption over 24 hours. 24 A significant reduction in SPID24 from baseline was seen with IV acetaminophen 1g plus rescue when compared with placebo plus rescue (P<0.007) (Figure 3a). Time to meaningful pain relief after the first dose was significantly shorter in subjects who received IV acetaminophen 1g plus rescue compared to the matched placebo plus rescue group, with median values of 24.9 versus 53.9 minutes, respectively (P<0.003). 24 Furthermore, an expanded analysis of these study data over 24 hours demonstrated that the mean pain intensity scores were significantly lower for the IV acetaminophen plus rescue group at each dosing interval through 18 hours (Figure 3b). 19,24 In major orthopaedic surgery, Sinatra and colleagues evaluated the analgesic efficacy of repeated doses of IV acetaminophen 1g versus placebo every six hours for 24 hours in 101 patients reporting moderate to severe pain following total hip or total knee replacement. Rescue IV patient-controlled analgesia (PCA) morphine was available to all patients. Patients were started on study medication the morning of the first postoperative day to allow for anesthesia washout and to establish a baseline. Efficacy was measured as: pain relief on a five-point verbal scale over six hours (primary endpoint); pain intensity on a 100-mm VAS and a four-point verbal scale over 24 hours; quantity of morphine consumed; time to first use of rescue medication; and patient satisfaction with pain management at 24 hours. 18 In the six-hour, single-dose evaluation period, IV acetaminophen 1g plus PCA morphine demonstrated superior pain relief versus placebo plus PCA morphine from 15 minutes to six hours (Figure 4). In the repeated- dose evaluation period, SPID24 was significantly reduced in the IV acetaminophen group compared with the placebo group (P<0.01). 25 FIGURE 3. Study in abdominal laparoscopic surgery a. Wininger SJ, et al. Clin Ther. 2010;32:2348-2369. b. Data on file. Cadence Pharmaceuticals, Inc. a b EDITED-Cadence Ofirmez Suppl copy 2_Layout 1 4/14/14 10:14 AM Page A5