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Pain Management After Elective Hallux Valgus Surgery: a Prospective Randomized Double-Blind Study Comparing Etoricoxib and Tramadol

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Pain Management After Elective Hallux Valgus Surgery: a Prospective Randomized Double-Blind Study Comparing Etoricoxib and Tramadol Pain Medicine Section Editor: Spencer S. Liu Pain Management After Elective Hallux Valgus Surgery: A Prospective Randomized Double-Blind Study Comparing Etoricoxib and Tramadol Metha Brattwall, MD,* Ibrahim Turan, MD, PhD,† and Jan Jakobsson‡ BACKGROUND: Pain is a common complaint after day surgery, and there is still a controversy surrounding the use of selective cyclooxygenase-2 (COX-2) inhibitors. In the present prospective, randomized, double-blind study we compared pain management with a selective (COX-2) inhibitor (etoricoxib) with pain management using sustained-release tramadol after elective hallux valgus surgery. METHODS: One hundred ASA 1 to 2 female patients were randomized into 2 groups of 50 patients each; oral etoricoxib 120 mg ϫ 1 ϫ IV ϩ 90 mg ϫ 1 ϫ day V–VII and oral tramadol sustained-release 100 mg ϫ 2 ϫ VII. Pain, pain relief, satisfaction with pain management, and need for rescue medication were evaluated during the first 7 postoperative days. A computed tomography scan evaluating bone healing was performed 12 weeks after surgery. A clinical evaluation of outcome (healing, mobility, and patient-assessed satisfaction) was performed 16 weeks after surgery. RESULTS: Two patients withdrew before discharge from the hospital. Ninety-eight patients, 81 ASA 1 and 17 ASA 2 (82 nonsmokers and 14 smokers), mean age 49 years (19–65), weight 64 (47–83) kg, and height 167 (154–183) cm were evaluated. Overall pain was well managed, but the mean visual analog scale (VAS) was significantly lower among etoricoxib patients evaluated during the entire 7-day period studied (12.5 Ϯ 8.3 vs. 17.3 Ϯ 11, P Ͻ 0.05). patient’s grading of pain relief (92 Ϯ 12 vs. 85 Ϯ 15, P Ͻ 0.05) and satisfaction with pain medication (47/49 vs. 39/49, P Ͻ 0.05) was higher among etoricoxib patients. Patients receiving tramadol reported significantly more side effects. Six patients, all in the tramadol group, discontinued the study because of side effects (P Ͻ 0.05). At 14-day follow-up 1 patient in the etoricoxib group and 5 patients in the tramadol group exhibited minor irritation in the wound area. The 12-week computed tomography scan showed good healing in 82 patients, 43 in the etoricoxib group, and 39 in the tramadol group. The study found ongoing healing in 11 patients, 4 in the etoricoxib group and 7 in the tramadol group. The 16-week patient-assessed Health Profile Quality of life revealed high patient satisfaction overall; 47 patients in each study group rated the outcome as satisfactory and the mean change in the patient-assessed quality of life VAS score was 6.2 and 2.6 for the etoricoxib and tramadol groups, respectively. Clinical follow-up at 16 weeks showed high functionality and no signs or symptoms of improper healing in any patient. CONCLUSION: Etoricoxib was found to be more effective and associated with fewer side effects in comparison with tramadol sustained release as a component of multimodel analgesia after elective hallux valgus surgery. There were no signs of impaired wound or bone healing associated with the use of etoricoxib. (Anesth Analg 2010;111:544–9) ain and nausea are common complaints after day case facilitate resumption of the normal activities of daily living.3 orthopedic surgery. Simple and effective pain medica- Nonsteroidal anti-inflammatory drugs (NSAIDs) have been tion after discharge is of importance to maintain quality shown to be effective analgesics in the early postoperative P 1,2 of care. The goal in optimizing postoperative pain manage- phase.4–7 The selective cyclooxygenase-2 (COX-2) inhibitors ment is to reduce pain, improve the quality of recovery, and may provide perioperative analgesia without the impaired hemostasis associated with nonselective NSAIDs. For ex- From the *Department of Anaesthesia, Sahlgrenska Academy, University ample, Desjardins et al. found rofecoxib 50 mg significantly Hospital Mo¨ndal, Gothenburg, Sweden; †Foot & Ankle Surgical Centre, Stock- holm, Sweden; ‡Department of Anaesthesia & Intensive Care, Karolinska more effective than was diclofenac sodium 100 mg for total Institutet, Institution for Physiology & Pharmacology, Stockholm, Sweden. pain relief, onset time, and duration of response after Accepted for publication March 30, 2010. bunionectomy.8 The institution received a grant from Merck Sharp & Dome. The potential negative effects from long-term NSAID Jan Jakobsson is currently affiliated with Foot & Ankle Surgical Centre, use on the healing process have always been controversial.9 Stockholm, Sweden. Conflict of Interest: The study had financial support by a grant from Merck Studies involving postoperative administration of COX-2 Sharp & Dome selective inhibitors for 10 to 14 days after cardiac surgery Address correspondence and reprint requests to Jan Jakobsson, Professor, demonstrated an increased risk of postoperative wound Foot & Ankle Surgical Centre, Stora¨ngsva¨gen 10, 11542 Stockholm, Sweden. infection and cardiovascular complications.10,11 This has Address e-mail to [email protected]. Copyright © 2010 International Anesthesia Research Society led physicians to question the wisdom of using COX-2 12 DOI: 10.1213/ANE.0b013e3181e3d87c selective inhibitors after orthopedic surgery, which was 544 www.anesthesia-analgesia.org August 2010 • Volume 111 • Number 2 compounded by the withdrawal of several COX-2 selective spontaneously through a facemask. Administration of inhibitors,13 and the retractions of Scott Reuben’s studies sevoflurane was stopped when skin suturing began. Surgery on NSAIDs.a was performed with a standardized technique including an A recent meta-analysis from the Cochrane library sup- osteotomy of the first metatarsal bone, excision of the exosto- ports the utility of a single dose of etoricoxib 120 mg for sis, and a split fixation of the osteotomy to allow full weight postoperative pain in low-risk patients. One study suggests bearing immediately after surgery.17 All procedures were that a 120-mg etoricoxib dose is as effective as, or better performed by a senior orthopedic surgeon (Ibrahim Turan) than, other commonly used analgesics.14 The effects of with Ͼ25 years of experience in forefoot surgery. etoricoxib for pain management for a longer period of time All patients were fast-tracked to the step-down unit, (e.g., up to 1 week after surgery) has not been extensively where they were provided the initial dose of study medi- studied. We have observed in noncontrolled studies the cation in combination with 30 mg paracetamol per kilo- analgesic efficacy of etoricoxib after ligament repair and gram orally. bunion surgery.15,16 Before discharge a dedicated research nurse instructed The aim of the present prospective, randomized, all patients on how to take study and rescue medications, if double-blind study was to compare the analgesic efficacy of needed, and how to complete the daily diary during the etoricoxib to that of tramadol sustained release as a com- first 7 days after surgery. Study medication and rescue ponent of multimodal analgesia during the first 7 days after analgesics were provided at discharge. All patients were elective hallux valgus surgery. provided oral paracetamol1gasfirst-line rescue and oral oxycodone 5 mg as second-line rescue analgesia and in- METHODS structed how to take rescue analgesia in an escalating The study protocol was approved by the local ethical manner, when needed. committee (2008/828 to 319) and EudraCT registered (Eu- A dedicated research nurse phoned each patient 1 to 2 draCT 2008 to 000,791–24) before inclusion of any patients. days after discharge to reinforce adherence to the study After receiving written informed consent, 100 female ASA protocol. All patients were seen by a research nurse 12 to 16 1 to 2 patients were randomized into 2 groups by computer days after surgery to assess wound healing and remove randomization: stitches. A computed tomography (CT) scan with multiplanar (a) etoricoxib 120 mg oral once daily for 4 days followed reformatted images along the axis of the first metatarsal was by 90 mg oral once daily for 3 days; conducted at 12 weeks to assess bone healing. The CT scans (b) tramadol sustained release 100 mg twice daily for 7 were evaluated by 2 physicians blinded to the randomization days. and otherwise not involved in the study. The images were The first dose was provided immediately after the end of assessed on a 3-grade scale: well-established healing, ongoing surgery when patients were adequately awake in the bone healing, and limited bone healing. recovery area. The study medication was prepared by a The Euro Quality 5 Dimension (EQ-5D) questionnaire hospital pharmacist in identical-appearing capsules accord- was used for a patient-assessed health profile quality of b ing to a computer-generated random number schedule. The life at baseline before surgery and at 16 weeks in conjunction patients, nurses, surgeons, and anesthesiologists directly with an outpatient clinical assessment of healing and func- involved in patient care were blinded to the content of the tionality by the patient and a physician otherwise not in- oral study medication capsules. volved in the study. The EQ-5D questionnaire is a generic tool Patients were provided oral and written pain medica- commonly used for assessing health profile quality of life. It tion information, and instructed on how to complete pain addresses the self-assessed experience of pain, mobility, activ- questionnaires (visual analog scale [VAS] 0 to 10, with 10 ity, self-care, and mode/depression with a pregraded scale defined as the worst possible pain), medication pain relief (impaired or yes/some impairment or some symptoms/no ϭ questionnaire (VAS scale 0 to 100, with 100 defined as symptoms adequate function). It also consists of a quality of ϭ ϭ perfect pain relief), satisfaction with pain medication (bi- life VAS scale, 100 excellent quality of life and 0 death. nary, satisfied/unsatisfied), and presence of any side ef- Functionality was assessed by a defined protocol with pr- fects (asked as an open question).
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