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Anesth Analg 2000;91:1221-1225
© 2000 International Anesthesia Research Society

REGIONAL ANESTHESIA AND PAIN MEDICINE

Postoperative Analgesic Effects of Celecoxib or Rofecoxib After Spinal Fusion Surgery

Scott S. Reuben, MD, and Neil Roy Connelly, MD

Department of Anesthesiology, 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
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 References
 
Nonsteroidal antiinflammatory drugs are recommended for the multimodal management of postoperative pain and may have a significant opioid-sparing effect after major surgery. The analgesic efficacy of the cyclooxygenase-2 nonsteroidal antiinflammatory drugs, celecoxib and rofecoxib, have not been evaluated after major orthopedic surgery. This study was designed to determine whether the administration of a preoperative dose of celecoxib or rofecoxib to patients who have undergone spinal stabilization would decrease patient-controlled analgesia (PCA) morphine use and/or enhance analgesia. We evaluated 60 inpatients undergoing spine stabilization by one surgeon. All patients received PCA morphine. The patients were divided into three groups. Preoperatively, they were given oral celecoxib 200 mg, rofecoxib 50 mg, or placebo. The outcome measures included pain scores and 24-h morphine use at six times during the first 24 postoperative h. The total dose of morphine and the cumulative doses for each of the six time periods were significantly more in the placebo group than in the other two groups. The morphine dose was significantly less in five of the six time intervals in the rofecoxib group compared with the celecoxib group. The pain scores were significantly less in the rofecoxib group than in the other two groups at two of the six intervals, and less than the placebo group in an additional interval. Although both rofecoxib and celecoxib produce similar analgesic effects in the first 4 h after surgery, rofecoxib demonstrated an extended analgesic effect that lasted throughout the 24-h study. We thus recommend that rofecoxib be used as a preoperative component of pain management that includes PCA morphine in patients undergoing spine stabilization surgery.

Implications: The cyclooxygenase-2-specific nonsteroidal antiinflammatory drugs, celecoxib and rofecoxib, both demonstrate an opioid-sparing effect after spinal fusion surgery. Celecoxib resulted in decreased morphine use for the first 8 h after surgery, whereas rofecoxib demonstrated less morphine use throughout the 24-h study period.


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 References
 
Nonsteroidal antiinflammatory drugs (NSAIDs) inhibit the synthesis of prostaglandins both in the spinal cord and at the periphery, thus diminishing the hyperalgesic state after surgical trauma (1,2). NSAIDs are useful as the sole analgesic after minor surgical procedures (2) and may have a significant opioid-sparing effect after major surgery (3). It is currently recommended that NSAIDs be used in the multimodal analgesic approach for the management of perioperative pain (4–6).

The mechanism of action of NSAIDs is through the inhibition of prostaglandin biosynthesis by the cyclooxygenase (COX) enzyme (7). COX exists as two distinct isoforms: COX-1 and COX-2 (8). COX-1 is constitutively active throughout the body and is responsible for mediating routine physiologic functions, including gastric mucosal function (9) and vascular hemostasis (10). In contrast, COX-2 is an inducible enzyme expressed from both polymorphonuclear leukocytes and macrophages after inflammatory stimuli (11).

Conventional NSAIDs nonspecifically inhibit both the COX-1 and the COX-2 isoforms (12). It is believed that the therapeutic activity of NSAIDs is primarily the inhibition of COX-2, whereas the toxicity results from inhibition of COX-1 (8). Early clinical trials demonstrate that endoscopic ulceration is significantly reduced with COX-2 specific inhibitors (9). These data, combined with the lack of platelet effect by COX-2-specific NSAIDs (8), may give reason for the improved safety of administering these drugs in the perioperative setting. Recently the COX-2-specific inhibitors, celecoxib and rofecoxib, have become available (8,13). At therapeutic concentrations, both of these NSAIDs inhibit the COX-2 isoenzyme without effecting the COX-1 isoform (8,13). Previous data have suggested that both rofecoxib (14–16) and celecoxib (17) have analgesic effects similar to those of the conventional NSAIDs when used for postdental surgery pain. However, the opioid-sparing effect of the COX-2 NSAIDs has not been evaluated after major surgery. This study was designed to evaluate the analgesic efficacy of administering a single preoperative dose of celecoxib or rofecoxib for spinal fusion surgery.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 References
 
After IRB approval, informed, written consent was obtained from 60 patients scheduled to undergo elective decompressive lumbar laminectomy with spinal fusion by a single surgeon. Patients were eligible for participation if they were at least 18 yr old, they weighed more than 40 kg, and they could operate a patient-controlled analgesia (PCA) device. Exclusion criteria included known allergy, sensitivity, or contraindications to morphine or any NSAID; renal insufficiency; a history of peptic ulcer; a history of a bleeding diathesis; and pregnancy.

Anesthesia was induced with propofol (2 mg/kg), fentanyl (5 µg/kg), and cisatracurium (0.2 mg/kg), and maintained with isoflurane in 70% N2O in O2. Neuromuscular blockade was antagonized with neostigmine (50 µg/kg). Patients were connected to a PCA pump (Abbott PCA Plus, Abbott Park, Chicago, IL) on arrival in the postanesthesia care unit. The PCA solution contained morphine 1 mg/mL. Initial settings were as follows: incremental dose, 2 mL; lockout interval, 8 min; and 4-h limit, 40 mL. The incremental dose was increased to 2.5 mL, and the 4-h limit was increased to 50 mL if analgesia was inadequate after 1 h. If analgesia remained inadequate after an additional hour, the incremental dose was further increased to 3.0 mL.

All patients received PCA morphine. Twenty patients were assigned to one of the three treatment groups in a double-blinded randomized manner:

Group P received an oral placebo 1 h before the anesthetic induction.
Group CEL received an oral dose of celecoxib 200 mg 1 h before the anesthetic induction.
Group ROF received an oral dose of rofecoxib 50 mg 1 h before the anesthetic induction.

These are the maximum doses of celecoxib and rofecoxib that have previously been shown to be effective in the management of acute postoperative pain (14–17).

Patients were asked to quantify their pain on a verbal analog pain scale (VbAPS) between 0 and 10 with 0 representing no pain and 10 the worst imaginable pain. Pain assessments and morphine use were made by a blinded observer at 4, 8, 12, 16, 20, and 24 h later. Intraoperative blood loss was determined by combining the blood collected in the suction canister as well as by estimating the blood present in the surgical sponges.

Demographic data (age, height, and weight), procedure duration, and blood loss were analyzed with analysis of variance. Pain scores and morphine doses were analyzed by using the Kruskal-Wallis test. If a significant result was obtained, Wilcoxon testing was performed to determine between which groups there was significance; a Bonferroni adjustment was made for multiple comparisons. Significance was determined at the P < 0.05 level.


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 References
 
There were no significant differences among the treatment groups with respect to age, height, weight, duration of surgery, or intraoperative blood loss (Table 1). There were significant differences among the groups with regard to the interval dose of morphine at each of the time intervals as well as the cumulative morphine dose (P < 0.0001; Table 2; Fig. 1). The total dose of morphine and the cumulative doses for each of the six periods were significantly more in the P group than in the ROF group (P < 0.0001; Table 2; Fig. 1). The total dose of morphine and two interval doses were significantly more in the P group than in the CEL group (P < 0.03; Fig. 2). The total dose of morphine (P < 0.0001) and interval dose during five of the six intervals (P < 0.01; Fig. 1) were significantly more in the CEL group than the ROF group.


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  		Table 1. Patient Demographics and Surgical Data
 

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  		Table 2. Morphine Consumption (mg) for the Six Time Periodsa
 


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  		Figure 1. Interval dose of morphine at each postoperative time interval. The mean morphine dose for each of the six periods was significantly increased in the control group than in the rofecoxib group (P < 0.0001). The mean morphine dose at the first two time intervals was significantly increased in the control group than in the celecoxib group (* P < 0.03). The mean morphine dose at five of the six time intervals was significantly increased in the celecoxib group than in the rofecoxib group (** P < 0.01). Values are mean ± SD.

 
There was a significant difference among the groups with regard to VbAPS after 8 (P < 0.03), 12 (P < 0.02), and 16 (P < 0.01) postoperative h (Table 3). The VbAPS were significantly higher in the P group than in the ROF group after 8 (P < 0.03), 12 (P < 0.03), and 16 (P < 0.01) postoperative h. The VbAPS were significantly higher in the P group than in the CEL group after 8 postoperative h (P < 0.02). The VbAPS were significantly higher in the CEL group than in the ROF group after 12 (P < 0.006) and 16 (P < 0.01) postoperative h.


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  		Table 3. Pain Scores for the Six Time Periodsa
 

   Discussion
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 Abstract
 Introduction
 Methods
 Results
 Discussion
References
 
A multimodal analgesic approach is recommended for the management of perioperative pain (4–6). Unless contraindicated, the pharmacological management should include a NSAID. Ketorolac, the only parenteral NSAID available in the United States, is often used in the perioperative setting. We previously demonstrated an approximate one-third reduction in PCA morphine use when ketorolac was administered in the postoperative period (18,19). However, since ketorolac has been marketed, there have been reports of deaths caused by gastrointestinal and operative site bleeding (20). As a consequence of these safety concerns, the drug’s license was suspended in many European countries (21). The European Committee for Proprietary Medicinal Products concluded that "ketorolac has a narrow therapeutic margin" (21). In contrast, the use of COX-2 specific inhibitors may represent a significant therapeutic advance in the management of acute pain. Because these compounds produce very little effect on COX-1, they should have a large therapeutic window. Preliminary data from animal studies have revealed that selective inhibition of COX-2 produces analgesia with substantial safety advantages over existing NSAIDs (22). Although COX-2 NSAIDs have demonstrated analgesic efficacy in mild-to-moderate pain after dental surgery, their efficacy in more severe pain is yet to be established.

Our study demonstrated a significant opioid-sparing effect with both celecoxib and rofecoxib when used in conjunction with PCA morphine after spinal fusion surgery. However, rofecoxib had a significantly greater duration of analgesic effect, as demonstrated by decreased morphine use throughout the six time periods. In contrast, celecoxib resulted in less morphine use for only the first two time periods (0–8 hours) after surgery. These results are similar to those of an earlier postoperative dental pain study in which rofecoxib 50 mg had an analgesic duration of >24 hours compared with 5 hours for celecoxib 200 mg (16).

Celecoxib and rofecoxib have different indications and dosing regimens. Celecoxib should be taken either once or twice daily for the management of osteoarthritis and twice daily for rheumatoid arthritis. Rofecoxib should be administered once daily for the management of osteoarthritis or acute pain. The recommended dose of rofecoxib for the treatment of acute postoperative pain is 50 mg. This dose has similar analgesic efficacy to both ibuprofen and naproxen (15). The efficacy of celecoxib in providing relief of acute postoperative pain is encouraging but limited and is not a generally approved use (17). The analgesic efficacy of a single dose of celecoxib 100 to 400 mg was superior to placebo but similar to aspirin after dental surgery (17). However, celecoxib 200 mg was less effective than ibuprofen. In the setting of acute postoperative pain, 200 mg appeared to be the full therapeutic dosage of celecoxib in that dosages of 400 mg conferred no additional analgesic benefit (17).

Although the perioperative administration of nonspecific NSAIDs may provide effective analgesia, their ability to decrease platelet aggregation and increase bleeding time, may increase the risk of perioperative bleeding (2,3,23). Because neither celecoxib nor rofecoxib inhibits platelet function (8), they may be safer analgesics when administered in the perioperative period. In fact, celecoxib 1200 mg daily had no effect on serum thromboxane or platelet function (17). Similarly, in doses of 1000 mg per day, rofecoxib had no effect on platelet aggregation or bleeding time (15). Our study demonstrated that a single oral dose of either celecoxib or rofecoxib administered before surgery resulted in no significant increase in the incidence of intraoperative bleeding.

Regarding the issue of cost: Our hospital acquisition cost for ketorolac 15 mg is $2.79, whereas the cost of celecoxib 200 mg is $1.94, and rofecoxib 50 mg is $2.81. To provide effective postoperative analgesia, ketorolac should be administered every 6 hours after spinal fusion surgery (19). Therefore, the 24-hour cost for ketorolac would be $11.16. In this study, it is evident that patients receiving celecoxib would require a dosing schedule of at least every 8 hours, resulting in a daily cost of $5.82. However, most of our patients recovering from spinal fusion surgery are unable to tolerate oral analgesic use for at least 18 hours after surgery, making the administration of celecoxib less practical.

We thus recommend that rofecoxib be used as a component of the pain regimen including PCA morphine in patients undergoing spine stabilization surgery. A single preoperative dose results in decreased morphine consumption and enhanced analgesia when compared with not receiving rofecoxib. Although both rofecoxib and celecoxib produce similar analgesic effects in the first 4 hours after surgery, rofecoxib demonstrated an extended analgesic effect which lasted throughout the 24-hour study period.


   Acknowledgments
 
The authors gratefully acknowledge Dr. R. Scott Cowan for allowing us to enroll his patients in the study, and Holly Maciolek, RN, Charles Gibson, RN, and Anne Moineau, RN, for their help in data collection. The authors acknowledge the secretarial assistance of Ms. Maria Colon.


   Footnotes
 
Funding was provided solely from the Department of Anesthesia.


   References
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 Introduction
 Methods
 Results
 Discussion
 References
 

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  5. Acute Pain Management Guideline Panel. Acute pain management: operative or medical procedures and trauma– clinical practice guideline. AHCPR Pub. No. 92-0032. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services, 1992;Feb:15–26.
  6. Task Force on Pain Management, Acute Pain Section. Practice guidelines for acute pain management in the perioperative setting. Anesthesiology 1995; 82: 1071–81.[ISI][Medline]
  7. Vane JR. Inhibition of prostaglandin synthesis as a mechanism of action of aspirin-like drugs. Nat New Biol 1971; 231: 232–5.[ISI][Medline]
  8. Hawkey CJ. COX-2 inhibitors. Lancet 1999; 353: 307–14.[ISI][Medline]
  9. Warner TD, Giuliano F, Vojnovic I, et al. Nonsteroid drug selectivities for cyclo-oxygenase-1 rather than cyclo-oxygenase-2 are associated with human gastrointestinal toxicity: a full in vitro analysis. Proc Natl Acad Sci 1999; 96: 7563–8.[Abstract/Free Full Text]
  10. Moncado S, Gryglewski R, Bunting S, Vane JR. An enzyme isolated from arteries transforms prostaglandin endoperoxides to an unstable substance that inhibits platelet aggregation. Nature 1976; 263: 663–5.[Medline]
  11. Seibert K, Masferrer JL. Role of inducible cyclooxygenase (COX-2) in inflammation. Receptor 1994; 4: 17–23.[ISI][Medline]
  12. Meade EA, Smith WL, DeWitt DL. Differential inhibition of prostaglandin endoperoxide synthase (cyclooxygenase) isozymes by aspirin and other non-steroidal anti-inflammatory drugs. J Biol Chem 1993; 268: 6610–4.[Abstract/Free Full Text]
  13. Crofford LJ, Lipsky PE, Brooks P, et al. Basic biology and clinical application of specific cyclooxygenase-2 inhibitors. Arthritis Rheum 2000; 43: 4–13.[ISI][Medline]
  14. Morrison BW, Christensen S, Yuan W, et al. Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib in post-dental surgery pain: a randomized, controlled trial. Clin Ther 1999; 21: 943–53.[ISI][Medline]
  15. Ehrich EW, Dallob A, DeLepeleire I, et al. Characterization of rofecoxib as a cyclooxygenase-2 isoform inhibitor and demonstration of analgesia in the dental pain model. Clin Pharmacol Ther 1999; 65: 336–47.[ISI][Medline]
  16. Malmstrom K, Daniels S, Kotey P, et al. Comparison of rofecoxib and celecoxib, two cyclooxygenase-2 inhibitors, in postoperative dental pain: a randomized, placebo- and active-comparator-controlled clinical trial. Clin Ther 1999; 21: 1653–63.[ISI][Medline]
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  19. Reuben SS, Connelly NR, Lurie S, et al. Dose-response of ketorolac as an adjunct to patient-controlled analgesia morphine in patients after spinal fusion surgery. Anesth Analg 1998; 87: 98–102.[Abstract/Free Full Text]
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  23. Schafer AI. Effects of nonsteroidal anti-inflammatory therapy on platelets. Am J Med 1999; 106: 25S–35S.[Medline]
Accepted for publication July 26, 2000.




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 Anesth. Analg.Home page
N. M. Gajraj
Cyclooxygenase-2 Inhibitors
Anesth. Analg., June 1, 2003; 96(6): 1720 - 1738.
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M. F. Watcha, T. Issioui, K. W. Klein, and P. F. White
Costs and Effectiveness of Rofecoxib, Celecoxib, and Acetaminophen for Preventing Pain After Ambulatory Otolaryngologic Surgery
Anesth. Analg., April 1, 2003; 96(4): 987 - 994.
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 J. Pharmacol. Exp. Ther.Home page
E. Niederberger, I. Tegeder, C. Schafer, M. Seegel, S. Grosch, and G. Geisslinger
Opposite Effects of Rofecoxib on Nuclear Factor-kappa B and Activating Protein-1 Activation
J. Pharmacol. Exp. Ther., March 1, 2003; 304(3): 1153 - 1160.
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 Br J AnaesthHome page
R. C. Hubbard, T. M. Naumann, L. Traylor, and S. Dhadda
Parecoxib sodium has opioid-sparing effects in patients undergoing total knee arthroplasty under spinal anaesthesia
Br. J. Anaesth., February 1, 2003; 90(2): 166 - 172.
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A. Turan, S. Emet, B. Karamanlioglu, D. Memis, N. Turan, and Z. Pamukcu
Analgesic Effects of Rofecoxib in Ear-Nose-Throat Surgery
Anesth. Analg., November 1, 2002; 95(5): 1308 - 1311.
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 Anesth. Analg.Home page
T. Issioui, K. W. Klein, P. F. White, M. F. Watcha, M. Coloma, G. D. Skrivanek, S. B. Jones, K. C. Thornton, and B. F. Marple
The Efficacy of Premedication with Celecoxib and Acetaminophen in Preventing Pain After Otolaryngologic Surgery
Anesth. Analg., May 1, 2002; 94(5): 1188 - 1193.
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 J Am Acad Orthop SurgHome page
R. S. Sinatra MD, J. Torres, and A. M. Bustos
Pain Management After Major Orthopaedic Surgery: Current Strategies and New Concepts
J. Am. Acad. Ortho. Surg., March 1, 2002; 10(2): 117 - 129.
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P. F. White
The Role of Non-Opioid Analgesic Techniques in the Management of Pain After Ambulatory Surgery
Anesth. Analg., March 1, 2002; 94(3): 577 - 585.
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 Br J AnaesthHome page
A. E. Pickering, H. S. Bridge, J.