Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial

Abstract

Multimodal pain management combines analgesics to improve analgesia and reduce side effects. This study investigates the fixed combination of diclophenac and orphenadrin (Neodolpasse(®) Infusion Solution) in patients after unilateral total hip arthroplasty (THA). This prospective, randomized, double-blind, placebo-controlled, multi-centre clinical study enrolled 120 patients receiving patient-controlled analgesia (PCA). Isotonic saline was infused as placebo. The primary efficacy goal was defined as reduction of PCA analgesics used over the first 24 h post-surgery. The study used a three-stage group sequential test design with two interim analyses. Analgesia was monitored by visual analogue scale and verbal rating. Infusion of the Neodolpasse(®) Infusion Solution resulted in a significant reduction in the PCA analgesic requirements by approximately 30% (38.7 ± 21.3 mg vs. 55.9 ± 31.1 mg; p = 0.0004) while maintaining adequate analgesia and patient safety. This study demonstrates that Neodolpasse(®) Infusion Solution significantly reduces PCA analgesic requirements without compromising analgesic effectiveness and safety in THA patients.

PROSPECT guideline for total hip arthroplasty: a systematic review and procedure‐specific postoperative pain management recommendations

“…Regular i.v. diclofenac and orphenadrine infusions after surgery and at 12 h reduced morphine patient‐controlled analgesia (PCA) consumption postoperatively [22]. McQuay et al.…”

“…Regular i.v. diclofenac and orphenadrine infusions after surgery and at 12 h reduced morphine patient-controlled analgesia (PCA) consumption postoperatively [22]. McQuay et al [23] showed that a combination of oral dexketoprofen 25 mg with tramadol 75 mg was superior to both medications alone for postoperative pain control.…”

“…Pre-operative and intra-operative Three studies showed analgesic benefit of NSAID administration [22][23][24]. Regular i.v.…”

Perioperative Opioid-sparing Strategies: Utility of Conventional NSAIDs in Adults

“…All included trials were conducted in adult populations aged 18 years or older, and 1 study was conducted specifically in a geriatric population over 65 years of age. 19 All studies were conducted in the surgical setting, and common surgeries in the trials reviewed included gynecologic surgery/cesarean delivery (n = 15), 12,13,18,[20][21][22][23][24][25][26] orthopedic/arthroscopic surgery (n = 10), 11,14,19,[27][28][29][30][31][32][33] and spinal surgery (n = 4). [34][35][36][37] Findings from individual NSAIDs are presented below.…”

Diclofenac Versus Ketorolac for Pain Control After Primary Total Joint Arthroplasty: A Comparative Analysis

“…A number of different agents and modalities have been studied as alternative pain therapies, including local or regional nerve blocks, acetaminophen, gabapentin, and nonsteroidal anti-inflammatory drugs (NSAIDs). In particular, NSAIDs have shown promise at maximizing analgesia while decreasing the opioid-related side effects and addiction risk [15][16][17][18][19][20]. Additionally, intravenous (IV) preparations have the benefit of greater bioavailability than oral medication for patients in need of acute pain management [21,22].…”