Abstract ID: A7
Abstract Title: Evaluation of Valdecoxib, a COX-2 Specific Inhibitor, as an Effective Opioid-Sparing Analgesic in Patients Undergoing Hysterectomy
Authors: Perov, M.D. S1, Liu, M.D. Z2, Choudhari, M.D. V3
Detroit Medical Center, Wayne State University Detroit Michigan USA1, Detroit Medical Center, Wayne State University Detroit Michigan USA2, Detroit Medical Center, Wayne State University Detroit Michigan USA3
Poster Type: Poster
ABSTRACT BODY
Introduction:Patients undergoing hysterectomy experience severe pain for 48-72 hours after surgery. Optimal postoperative recovery such as earlier ambulation, earlier discharge and better rehabilitation after hysterectomy is dependent on satisfactory postoperative pain management. Use of opioids to manage pain in the postoperative period is associated with undesirable opioid-related side effects. Valdecoxib is a potent COX-2 specific inhibitor developed for the treatment of pain and inflammation. Valdecoxib is approximately 28,000-fold more selective against COX-2 than COX-1 in vitro. Consistent with this COX-1 sparing effect, valdecoxib even at a supratherapeutic clinical dose, demonstrates no effect on platelet function in healthy elderly and non-elderly subjects, and is associated with a significantly lower incidence of endoscopically detected ulcers in osteoarthritis patients compared with the conventional NSAIDs ibuprofen and diclofenac. No previous studies have examined the effects of oral valdecoxib in patients undergoing hysterectomy. The aim of this study is to evaluate the opioid-sparing effects and analgesic efficacy of valdecoxib 40 mg given in divided doses in patients undergoing hysterectomy.
Materials and Methods:Patients were enrolled in a multiple-dose, randomized, double blind, placebo-controlled study. Inclusion criteria includes women (18–64 yrs) for elective hysterectomy, body weight of at least 50 kg, ability to understand the use of pain assessment scales and the PCA device, and a preoperative health status ASA I-II. Exclusion criteria consisted of patients with known allergy to nonsteroidal anti-inflammatory drugs, sulfas and history of bleeding disorder, esophageal and gastric ulceration, uncontrolled chronic disease, acute renal or hepatic disorder, and chronic drug abuse. Consumption of morphine by PCA, patient pain intensity and adverse reactions was recorded. T-tests were used to determine statistical significance. Significance was defined as p < 0.01.
Results:Patients were given their first dose of study medication (valdecoxib or placebo/ (corn starch)) 1-3 hours prior to surgery, and subsequently every 12 hours for 48 hours, for a total of 5 doses of study medication. The following information is summarized in the tables below. Eleven (n=11) patients (5 placebo, 6 valdecoxib) were enrolled. There was no statistical difference among basic demographic data: Age, height and weight (pounds). Likewise, no differences were found in the duration (minutes) of surgery, total fentanyl usage (mcg) during surgery, estimated blood loss (ml), and crystalloid (ml) given during surgery. Consumption of morphine (mg) in the PACU, 12 hrs, 24 hrs, 36 hrs and 48 hrs was not significantly different between placebo and valdecoxib: 2 vs 2 at PACU; 25 vs 27.6 at 12 hr, 17.3 vs 19.6 at 24 hrs, 4.2 vs 6.3 at 36 hrs. At 48 hrs, one patient in the placebo group still used the PCA morphine. All others were discontinued or discharged from the hospital. VAS scores were significantly less with the valdecoxib group at 24hrs, 6 vs 3.17 (p = 0.002) at 36 hrs, 4.4 vs 2.16 (p =0.016) and at discharge (48 hrs); 2.45 vs 1.33 (p = 0.0008). There were no serious adverse events among patients who received valdecoxib.
Discussion:Pt VAS improved
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Reg Anesth Pain Med 2005; 30(3):A7