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Anesth Analg 2007;105:222-227
© 2007 International Anesthesia Research Society
doi: 10.1213/01.ane.0000265440.98491.e2

ANALGESIA

Evaluating the Analgesic Efficacy of Administering Celecoxib as a Component of Multimodal Analgesia for Outpatient Anterior Cruciate Ligament Reconstruction Surgery

Scott S. Reuben, MD*{dagger}, Evan F. Ekman, MD{ddagger}, and Derek Charron, BS§

From the *Department of Anesthesiology, Baystate Medical Center, Springfield, Massachusetts; {dagger}Department of Anesthesiology and Pain Medicine, Tufts University School of Medicine, Boston, Massachusetts; {ddagger}Department of Orthopaedic Surgery, Parkridge Surgery Center, Columbia, South Carolina; and §Department of Pharmacy, Baystate Medical Center, Springfield, Massachusetts.

Address correspondence and reprint requests to Scott S. Reuben, MD, Department of Anesthesiology, Baystate Medical Center, 759 Chestnut St., Springfield, MA 01199. Address e-mail to scott.reuben{at}bhs.org.

Abstract

BACKGROUND: Cyclooxygenase-2 inhibitors may play an important role in multimodal management of pain after orthopedic surgery. We examined the analgesic efficacy of administering celecoxib as a component of a multimodal analgesic regimen for outpatient anterior cruciate ligament (ACL) surgery.

METHODS: Two-hundred consecutive patients were randomized to receive acetaminophen 1000 mg and either celecoxib 400 mg or placebo 1–2 h before ACL surgery. All patients received intraarticular analgesics (bupivacaine, clonidine, and morphine) and had an external cooling system applied to the operative knee. After discharge, patients were instructed to take acetaminophen 1000 mg every 6 h and either celecoxib 200 mg every 12 h or matching placebo for the first 14 days postoperatively. Oxycodone 5–10 mg was available for rescue analgesia.

RESULTS: Patients in the celecoxib group were more likely to experience less pain in the recovery room (P < 0.01) and require less opioids (P < 0.001) for postoperative analgesia. These patients reported a lower incidence of postoperative nausea and vomiting (P < 0.05) and were discharged home earlier (P < 0.05). While at home, patients in the celecoxib group reported lower pain scores both at rest (P < 0.05) and with movement (P < 0.01), and used less oxycodone at all postoperative time intervals.

CONCLUSIONS: The perioperative administration of celecoxib decreases postoperative pain, opioid use, postoperative nausea and vomiting, and recovery room length of stay. These results support the use of celecoxib as a component of a preventive multimodal analgesic technique for ACL surgery.

Arthroscopic reconstruction of the anterior cruciate ligament (ACL) is a common outpatient procedure associated with considerable postoperative pain (1). Unrelieved postoperative pain may delay discharge, prolong hospital stay, impair rehabilitation, and delay recovery, resulting in poorer outcome and greater use of health care resources (2).

Analgesic treatment before surgery (preemptive analgesia) may be more effective in controlling pain than administering analgesic therapy in response to pain after surgery (3). The evidence in support of preemptive analgesia has been equivocal, with a systematic review demonstrating no benefit (4), while a more recent review demonstrated improved outcome (5). Current analgesic techniques are intended to reduce central sensitization arising from noxious inputs throughout the entire operative and postoperative period (preventive analgesia), and not just those brought about by incision (preemptive analgesia) (6). Therefore, duration and efficacy of an analgesic intervention are most important for treating pain after surgery. Optimal pain relief allowing normal function is difficult to achieve with a single drug or method (7). It is currently recommended that analgesic regimens that operate through different mechanisms (multimodal analgesia) be combined (2,7). Multimodal analgesic regimens described in the literature for ACL reconstruction include: nonsteroidal antiinflammatory drugs (NSAIDs), intraarticular analgesics, ketamine, regional nerve blocks, cryotherapy, and opioids (1).

The perioperative administration of NSAIDs plays an important role in the multimodal management of acute pain (1–3). Although the preoperative administration of nonspecific NSAIDs may provide effective analgesia, their use is limited by a decrease in platelet aggregation and an increase bleeding time (8), which may increase the risk of perioperative bleeding (9,10). Although IV ketorolac can provide effective analgesia for ACL surgery (11), it is currently contraindicated for use as a preemptive analgesic (12). We have observed increased perioperative bleeding with the preemptive administration of either ketorolac or ibuprofen for outpatient ACL surgery, and have since discontinued its use (1). Celecoxib, a cyclooxygenase-2 (COX-2) specific NSAID, has no effect on platelet aggregation or bleeding time (13), and has demonstrated analgesic efficacy after major orthopedic surgery (14). The goal of this study was to assess the analgesic efficacy of celecoxib as a component of a preventive multimodal analgesic technique for patients undergoing outpatient ACL surgery.

METHODS

After IRB approval, informed written consent was obtained from 200 patients undergoing primary ACL reconstruction surgery for this randomized, double-blind, placebo-controlled study. Patients were excluded if they had other ligament tears, had undergone a previous operation in the same knee, had undergone tibial osteotomy or meniscal reconstruction, had evidence of chondral damage or degeneration, had injured the contralateral knee, complained of patellofemoral symptoms, had an acute lesion of the ACL (defined as interval between the injury and surgery <30 days), were medicated with opioids preoperatively, or had a contraindication to the use of NSAIDs or oxycodone. Two-hundred consecutive patients were randomly assigned to receive either celecoxib 400 mg (n = 100) or matching placebo (n = 100) 1–2 h before surgery according to a computer-generated randomization list. The study drugs (celecoxib and placebo supplied by Pfizer, NY, NY, as identical appearing capsules) were prepared by the hospital pharmacy in identical containers marked with the name of the project and consecutive patient numbers. During the study, the randomization list was held in the hospital pharmacy and released only after study completion. Investigators, pharmacists, and clinical staff were blinded to treatment group assignments. All patients were given acetaminophen 1000 mg with celecoxib or placebo 1–2 h before surgery. Anesthesia was induced with propofol 2 mg/kg, fentanyl 2 µg/kg, and ketamine 30 mg, and was maintained with 30%–50% N2O in O2, and sevoflurane 1%–2% end-tidal concentration delivered via either an endotracheal tube or laryngeal mask airway. Ondansetron 4 mg IV was administered prophylactically for the prevention of postoperative nausea and vomiting (PONV). All patients received 20 mL of intraarticular bupivacaine 0.25% and clonidine 50 µg before surgical incision. ACL surgery was performed using a bone-tendon-bone central-third patellar tendon autograft. Before awakening, all patients received 20 mL intraarticular bupivacaine 0.25%, morphine 5 mg, and clonidine 50 µg, and an external cooling system was applied to the operative knee.

In the postanesthesia care unit (PACU), patients were asked to rate their pain every 15 min using a numerical rating scale (NRS) ranging from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain. Analgesia was initially managed with fentanyl 25 µg IV every 5 min, followed by oral oxycodone 5–10 mg every 3 h for a NRS ≥3. PONV was recorded if present. Patients were discharged from the hospital when they were oriented to time and place, able to void, had stable vital signs, had minimal pain (NRS ≤3), were not experiencing PONV, and could ambulate with the assistance of crutches. Discharge time was defined as the time from the completion of surgery until patients met these discharge criteria. Unplanned admission (on the day of surgery) and readmission (after same-day surgery) associated with an anesthesia-related issue (pain management, PONV, somnolence, or urinary retention) were recorded.

After discharge from the hospital, patients were instructed to take acetaminophen 1000 mg every 6 h and either celecoxib 200 mg every 12 h or matching placebo (according to randomization) for the first 14 days postoperatively. In addition, patients were instructed to take oxycodone 5–10 mg every 3 h for an NRS ≥3. All patients were enrolled in an accelerated rehabilitation program as described by Shelbourne and Nitz (15). This protocol emphasizes full weight bearing and full knee extension on the first postoperative day with a goal of returning to normal activities, including full sports participation, by 6 mo. While at home, patients were asked to record their daily NRS pain scores and oxycodone use in a diary. NRS pain scores represented their average pain score during the previous 24 h. Pain scores were obtained both at rest and with movement. Patients were contacted daily by telephone by a research nurse to ensure compliance with study medications and pain diary documentation.

The present manuscript considered the short-term (up to 14 days) outcome in this population of patients. In a companion paper, we examined the long-term outcome (up to 6 mo) in this same population of patients (16).

The primary end-point was NRS pain score. The anticipated treatment effect was estimated based on our previous ACL study (17), in which mean postoperative pain scores were 5.5 ± 1.5. Assuming a 50% reduction in pain scores would be clinically significant, 40 patients per group would be necessary to provide 90% power with an {alpha} = 0.05. Group means for continuous variables were compared with Student's t-test for unpaired data. For noncontinuous data, comparisons were made with the Mann–Whitney U-test. Tests for association of binary variables were made by {chi}2 analysis. Bonferroni corrections for multiple comparisons were used when applicable. P < 0.05 was considered statistically significant.

RESULTS

There were no significant differences between the two groups with respect to demographic variables, operative times, operative site (Table 1), or preoperative level of sports participation (Table 2). The mean time interval from injury to surgery was 2.7 mo (range, 1–5 mo), which was similar between the two groups.


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  		Table 1. Patient Demographics, Surgical, and Recovery Room Data

 

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  		Table 2. Preinjury Sport Participation

 

Patients in the celecoxib group were significantly more likely to experience less pain in the PACU (P < 0.01) and require less opioids (P < 0.001) for postoperative analgesia (Table 1). Further, these patients reported a lower incidence of PONV (P < 0.05) and were discharged earlier from the hospital compared to the control group (P < 0.05) (Table 1). All patients took their study medications according to protocol and completed their pain diaries. While at home, patients in the celecoxib group reported lower pain scores at rest (P < 0.05) (Fig. 1) and with movement (P < 0.01) (Fig. 2), and used less oxycodone (P < 0.01) (Fig. 3) compared to the control group at all postoperative time intervals.


Figure 138
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  		Figure 1. Numerical rating scale (NRS) pain scores at rest over the 14 postoperative days. The group receiving celecoxib reported lower pain scores at all postoperative time intervals. Data are shown as mean ± sem; (*P < 0.05 compared to the control group); ({dagger}P < 0.01 compared to the control group).

 

Figure 238
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  		Figure 2. Numerical rating scale (NRS) pain scores with movement over the 14 postoperative days. The group receiving celecoxib reported lower pain scores at all postoperative time intervals. Data are shown as mean ± sem; ({dagger}P < 0.01 compared to the control group).

 

Figure 338
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  		Figure 3. Oxycodone use in milligrams (mg) over the 14 postoperative days. The group receiving celecoxib used less oxycodone at all postoperative time intervals. Data are shown as mean ± sem; ({dagger}P < 0.01 compared to the control group).

 

Two patients in the control group were admitted immediately after surgery and four patients were readmitted to the emergency room or hospital ward (Table 1). Of these six patients, two were admitted for surgical complications (evaluation for deep venous thrombosis or effusion), three were admitted for refractory pain, and one for persistent PONV. In the celecoxib group, no patients were admitted immediately after surgery, and two patients were readmitted to the emergency room for persistent PONV. These differences were not statistically significant.

DISCUSSION

This study demonstrated that patients who received celecoxib as a component of a preventive multimodal analgesic technique had immediate benefits in the PACU, including reduced pain, opioid use, PONV, and length of stay. After discharge to home, while continuing to take celecoxib, these patients had reduced pain scores and opioid use.

Cost-containment issues have had a major impact on the volume of ambulatory surgical procedures. As surgical and pain management techniques continue to improve, more complex surgeries will be performed on an outpatient basis. ACL reconstruction, which has been associated with hospital stays of up to 1 wk, is now routinely performed in an outpatient setting for most patients (1). Kao et al. (18) were the first to report the effectiveness of outpatient ACL reconstruction. They reported cost-savings of up to 58%. Effective pain management may become the limiting factor in determining discharge eligibility in patients undergoing outpatient ACL surgery.

Recent advances in our understanding of the pathophysiology of acute pain has led to the development of effective perioperative analgesic regimens (19). Recent studies have supported the concept that neuronal hypersensitivity and nociception accompanying surgical trauma are maintained by the afferent barrage of sensitized nociceptors throughout the operative and postoperative periods (6). Thus, the goal of preventive analgesia is to reduce central sensitization that arises from noxious inputs throughout the entire postoperative period, and not just from those occurring during the surgical incision. Hopefully this can be accomplished by using combinations of several analgesics working at different nociceptive sites.

NSAIDs inhibit the synthesis of prostaglandins both in the spinal cord and at the periphery, thus diminishing the hyperalgesic state after surgical trauma (20). NSAIDs are useful as the sole analgesic after minor operative procedures (9) and may have an important opioid-sparing effect after a major operation (21). The practice guidelines for acute pain management in the perioperative setting specifically state that "unless contraindicated, all patients should receive an around-the-clock regimen of NSAIDs, COXIBS, or acetaminophen" (22). We chose to use celecoxib because of its efficacy in the perioperative management of pain after orthopedic surgery (14,23,24) and lack of platelet inhibition (13). When used as part of a multimodal analgesic approach for arthroscopic knee surgery, celecoxib improved analgesia and reduced opioid-related adverse effects (24). Despite the theoretical advantages of using celecoxib in the perioperative period, it is not known whether similar analgesia may have been obtained by administering a nonspecific NSAID during the postoperative period.

One potential concern regarding the use of COX-2 inhibitors has been their possible role in increasing cardiovascular morbidity (25). Theoretical concerns were borne out when a fivefold increase in the incidence of myocardial infarction was seen in the Vioxx Gastrointestinal Outcome Research (VIGOR) study (26), possibly related to a prothrombotic state caused by selective COX-2 inhibitors (27). Valdecoxib and the parenteral pro-drug parecoxib have also been associated with an increased risk of myocardial infarctions (1.6% vs 0.7%) after administering a supramaximal dose (40 mg twice daily) for 14 days after coronary artery bypass grafting surgery (28). However, no increase in cardiovascular events was observed with a therapeutic dosing of parecoxib followed by valdecoxib for general and orthopedic procedures (29). A review of NSAID usage in patients enrolled in the Kaiser Permanente health care system in CA suggested that cardiovascular toxicity may be related to all NSAIDs, and not just COX-2 specific inhibitors (30). During 2,302,029 person-years of follow-up, this study showed a significant increased risk of adverse cardiovascular events among users of diclofenac (relative risk = 1.69) (P = 0.06), indomethacin (relative risk = 1.30) (P = 0.005), and naproxen (relative risk = 1.14) (P = 0.01) compared to non-NSAID users. A joint meeting of the United States Food and Drug Administration Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee reaffirmed that COX-2 inhibitors are important treatment options for pain management, and that the cardiovascular risk associated with celecoxib is similar to that associated with commonly used nonspecific NSAIDs (31).

In addition to celecoxib, acetaminophen was administered during the perioperative period. Acetaminophen has been shown to have a synergistic analgesic effect when administered with celecoxib (32). Although the mechanism of action is still poorly understood, some investigators have suggested that acetaminophen provides an analgesic effect through the inhibition of COX-3 in. the brain (33). In addition to these preventive analgesics, both groups received pre- and postincisional intraarticular bupivacaine, clonidine, and morphine, ketamine, and an external cooling system was used in the postoperative period. These preemptive multimodal analgesic techniques have demonstrated efficacy after ACL surgery (1). It may be argued that a femoral nerve block might have provided superior analgesia compared with intraarticular local anesthesia after ACL surgery (34). However, several investigators have failed to observe any significant benefit of a femoral nerve block compared to intraarticular analgesics for ACL surgery (35,36).

Although NSAIDs may provide an opioid-sparing effect, their ability to decrease opioid-related side effects is controversial. One metaanalysis examined whether there is any advantage of multimodal analgesia with acetaminophen, NSAIDs, or COX-2 inhibitors when added to patient-controlled analgesia morphine (37). The use of NSAIDs was associated with a decrease in the incidence of PONV and sedation. However, the use of COX-2 inhibitors or acetaminophen did not decrease the incidence of opioid-related adverse events when compared to placebo. One criticism of the studies assessing opioid-related adverse effects is that they used methodology that does not accurately reflect conditions in clinical practice (38). NSAIDs are more likely to be used in multiple doses (which demonstrate superior analgesia versus placebo) (37), rather than single doses for the management of postoperative pain. In addition, a more comprehensive multimodal approach, rather than bimodal therapy, is probably needed to demonstrate a reduction in opioid-related adverse events and improvement in functional outcomes.

The use of celecoxib as a component of a multimodal analgesic therapy resulted in a reduction in opioid use, postoperative pain, and PONV during the immediate postoperative period. Fewer patients in the celecoxib group required either parenteral (22% vs 64%) or oral (12% vs 38%) opioids compared to the control group respectively. Further, there were fewer postoperative nursing interventions for the treatment of PONV in the celecoxib group on the day of surgery, but this study was under-powered to determine a difference in PONV based on the incidence of unplanned hospital admissions or readmissions. We did not follow PONV after discharge from the PACU. The reduction in PONV in the PACU may have been due to the reduction in postoperative pain or perioperative use of opioids, both of which are independent risk factors for PONV (39). Further, it has been demonstrated in an animal model that activation of the medullary vomiting center involves prostaglandins, and that the preemptive administration of COX inhibitors significantly decreases lipopolysaccharide-induced emesis (40). Perhaps, the preemptive administration of celecoxib, which demonstrates penetration across the blood–brain barrier (41), contributed to a reduction in centrally mediated PONV.

The reduction in PACU length of stay observed in those patients receiving celecoxib may have been due to the lower incidence of PONV and improved pain relief. Unrelieved pain and PONV are common reasons for prolonged hospital stay, unanticipated admission, and hospital readmission after ambulatory surgery (42). Although we observed a lower incidence of unplanned admission and readmissions in the celecoxib group, this did not reach statistical significance.

In conclusion, we observed a significant reduction in length of stay, postoperative pain, opioid use, and the incidence of PONV when celecoxib was used as part of a preventive multimodal analgesic technique for the management of pain after outpatient ACL surgery. The analgesic benefits continued for 14 days postoperatively. Our companion manuscript examines the long-term (6 mo) outcome in this same population of patients (16). These data reinforce the concept that pain management is important throughout the operative continuum, from the operative to postdischarge and recovery periods. Future prospective, randomized, controlled trials involving preventive multimodal analgesic techniques are needed to determine its efficacy, appropriate timing, as well as its impact on clinical and economic outcomes after surgery.

Footnotes

Accepted for publication March 8, 2007.

Supported in part from an unrestricted medical school grant from Pfizer and from institutional and departmental sources.

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Lippincott, Williams & Wilkins Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins and Stanford University Libraries' HighWire Press®. Copyright 2007 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999 HighWire Press