mobic and Hernia--Inguinal

Currently available local anesthetics have not demonstrated sufficient analgesia beyond 12-24 h postoperatively. The purpose of the study was to assess the safety and efficacy of HTX-011 (bupivacaine and meloxicam in Biochronomer. A phase 3, randomized, double-blind, active-controlled multi-center study (EPOCH 2; NCT03237481) in subjects undergoing unilateral open inguinal herniorrhaphy with mesh placement was performed. Subjects randomly received a single intraoperative dose of HTX-011, immediate-release bupivacaine HCl, or saline placebo prior to closure.. The study evaluated 418 subjects, and the primary and all key secondary efficacy endpoints were in favor of HTX-011. HTX-011 reduced mean pain intensity by 23% versus placebo (primary endpoint; p < 0.001) and by 21% versus bupivacaine HCl (p < 0.001) with significant reductions in the number of patients experiencing severe pain. Opioid consumption over 72 h was reduced by 38% versus placebo (p < 0.001) and 25% versus bupivacaine HCl (p = 0.024). Overall, 51% of HTX-011 subjects were opioid-free through 72 h (versus 22% for placebo [p < 0.001] and 40% for bupivacaine HCl [p = 0.049]). HTX-011 was generally well-tolerated with fewer opioid-related adverse events reported compared to the bupivacaine HCl and placebo and no evidence of local anesthetic systemic toxicity.. HTX-011 demonstrated significant improvement in postoperative pain control and a clinically meaningful reduction in opioid consumption when compared to the most widely used local anesthetic, bupivacaine HCl.

Topics: Adult; Analgesics, Opioid; Anesthetics, Local; Bupivacaine; Double-Blind Method; Female; Hernia, Inguinal; Herniorrhaphy; Humans; Male; Meloxicam; Middle Aged; Pain Management; Pain Measurement; Pain, Postoperative

To investigate the effect of the administration of a single dose of meloxicam pre-emptively on postoperative pain management in patients who underwent inguinal hernia repair under local anaesthesia.. Fifty patients who underwent inguinal hernia repair under local anaesthesia during the period November 2005 to May 2006 were recruited into the study prospectively. The patients were randomized to two groups regarding administration and non-administration of pre-emptive meloxicam. The postoperative visual analogue pain scale (VAS) values at 4, 8, 12 and 24 hours and analgesic needs of the patients were recorded. No difference was found between the groups in terms of age, gender, hernia localization and type. The VAS values of the patients regarding their pain severity were evaluated at 4, 8, 12 and 24 hours and were significantly lower in the group which received meloxicam pre-emptively (p = 0.001, 0.0001, 0.003 and 0.0001 respectively). The need for non-steroidal anti-inflammatory drug was also found to be significantly lower (p = 0.0001).. Postoperative pain severity and hence analgesic requirement were significantly decreased in the patients who received meloxicam pre-emptively. Single dose pre-emptive meloxicam seems to be an effective analgesic therapy for patients undergoing inguinal hernia repair under local anaesthesia. It thereby improves patients comfort and should be considered for use in outpatient surgery.

Topics: Anesthesia, Local; Anti-Inflammatory Agents, Non-Steroidal; Female; Hernia, Inguinal; Humans; Male; Meloxicam; Middle Aged; Pain Measurement; Pain, Postoperative; Prospective Studies; Thiazines; Thiazoles

To distinguish between local and systemic drug effects, we compared pain scores, analgesic consumption and plasma concentrations after local vs i.v. administration of meloxicam 7.5 mg in patients with inguinal hernia repair.. In a double-blind, randomized study 56 patients received either local or i.v. meloxicam 7.5 mg. Postoperative pain was assessed with a visual analogue scale (VAS) at rest, on mobilization, and on coughing, the need for supplementary analgesics (fentanyl i.v. and/or acetaminophen-codeine tablets) was recorded, and blood samples were drawn during 24 hr after meloxicam administration.. No significant differences were found between groups with respect to pain scores, or in the consumption of supplementary analgesics. Following local application of meloxicam, the peak plasma concentration (C(max)) of 0.5 +/- 0.2 mg*L(-1) achieved after 1.8 +/- 0.5 hr was much lower than the C(max) of 2.5 +/- 0.9 mg*L(-1) achieved immediately after i.v. administration (P <0.05). Mean meloxicam plasma concentration after infiltration was significantly lower than after i.v. doses for the first three hours after administration (P <0.05).. We showed no differences in pain scores and analgesic consumption between local and i.v. administration of meloxicam 7.5 mg during the first 24 hr after herniorrhaphy, while plasma concentration of meloxicam was lower after local administration. These results indicate a lack of difference in pain relief after concentrating meloxicam at the hernia wound or after achieving high blood levels rapidly (i.v.). Local administration of meloxicam may confer an advantage over systemic administration by eliciting lower incidences of systemic adverse effects.

Topics: Administration, Topical; Adult; Aged; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Female; Hernia, Inguinal; Humans; Injections, Intravenous; Male; Meloxicam; Middle Aged; Pain, Postoperative; Thiazines; Thiazoles

Most severe pain occurs within the first 72 hours after an operation, and current local anesthetics have a limited duration of action. HTX-011 is a dual-acting, local anesthetic containing bupivacaine, and low-dose meloxicam in an extended-release polymer. In a prior phase 3 inguinal herniorrhaphy study, HTX-011 alone provided superior pain relief for 72 hours and significantly decreased opioid use compared with saline placebo and bupivacaine hydrochloride. This open-label study assessed the safety, efficacy, and opioid-sparing properties of HTX-011 as the foundation of a scheduled, nonopioid, multimodal analgesia regimen in patients undergoing open inguinal herniorrhaphy.. This study was conducted in 2 sequential cohorts. All patients received a single, intraoperative dose of HTX-011 prior to wound closure, followed by a scheduled postoperative regimen of oral ibuprofen and acetaminophen for 72 hours. Patients in cohort 2 also received a single intraoperative dose of ketorolac. Opioid analgesics were available by request only.. More than 90% of patients remained opioid-free through 72 hours postoperatively, and 83% of patients remained opioid-free through day 28 (last study visit). Pain was well controlled, and mean intensity of the pain never increased higher than the mild range during the first 72 hours. Ketorolac did not demonstrate any additional benefit. HTX-011 with this multimodal analgesia regimen was well tolerated.. HTX-011 when used as the foundation of a nonopioid, multimodal analgesia regimen, provided effective and well-tolerated analgesia without the need for opioids in the majority of patients recovering from an open inguinal herniorrhaphy.

Topics: Adult; Aged; Analgesics, Opioid; Anesthetics, Local; Bupivacaine; Female; Hernia, Inguinal; Herniorrhaphy; Humans; Male; Meloxicam; Middle Aged; Pain, Postoperative