The effects of a preoperative steroid/anesthetic injection on post-tonsillectomy pain. (Original Article).

Abstract

We conducted a placebo-controlled, single-blind study to determine the efficacy of a local preoperative injection of a steroid/anesthetic combination in preventing posttonsillectomy pain. We randomized 21 adults to receive either triamcinolone/bupivacaine on the left side and saline on the right or vice versa. Injections were administered in the area of the tonsillar pillars following intubation and prior to tonsillectomy. Based on the "generalized estimating equations" model of statistical analysis, we found no significant difference in the degree of postoperative pain between the active-treatment and control sides.

Introduction

Otolaryngologists have dealt with the issue of postoperative tonsillar pain since the earliest days of the procedure. Postoperative pain can have a detrimental effect on patients and can increase the risk of postoperative complications. The consequences of postoperative pain include dehydration, the need for narcotic medication, a higher risk of bleeding, and a greater number of missed school or work days. (1)

The search for effective pain prevention is valid. Although many protocols have been tried, no one standard for controlling postoperative pain currently exists. Although electrocautery is the most widely used technique, many newer surgical modalities have been developed in the hope of not only decreasing postoperative pain, but in shortening operative time, as well. Pharmacologic and other adjuvant strategies have also been extensively investigated with the goal of achieving better postoperative pain control. Protocols involving steroids, (2-10) anesthetics, (9-13) antibiotics, (9,10,14) catecholamines, (10,11,15) and nonsteroidal anti-inflammatory drugs (16) have been attempted with varying results. Even the use of radiation has been reported. (17)

Previous experience with steroids has not been associated with an increase in complications during post-tonsillectomy recovery, and these agents are commonly used in the otolaryngology community. (2,3,6,7,9) To our knowledge, no study of local preoperative steroid/anesthetic injections for postoperative tonsillectomy pain has been previously described in the literature. In this article, we describe our study of this regimen.

Patients and methods

After receiving approval from our hospital's internal review board, we began recruiting adult candidates for our study. Each candidate provided a thorough history and underwent a physical examination prior to study entry. All candidates were also evaluated with respect to our study's inclusion and exclusion criteria. Inclusion criteria included age between 18 and 65 years and the presence of recurrent tonsillitis (defined as at least seven infections in 1 year, at least five in 2 consecutive years, or at least three per year for 3 consecutive years), asymmetric tonsils, or tonsillar hypertrophy. Exclusion criteria included the presence of diabetes, an episode of peritonsillar abscess or tonsillitis during the preceding 2 weeks, surgery within the previous 2 weeks, the current use of a systemic steroid, a known hypersensitivity to either of the two drugs used in this study (triamcinolone and bupivacaine), and the presence of peptic ulcer disease.

Following our initial screening, 21 patients met the eligibility requirements for our study. They were randomized on the basis of their Social Security numbers to receive either triamcinolone/bupivacaine on the left side and saline on the right or vice versa. All patients were blinded to the protocol used in their particular case. Each tonsillectomy was performed by one of two surgeons. The two surgeons had similar levels of experience, and both used electrocautery for tonsil removal. Adenoidectomy was not performed.

The study medication was a mixture of 1.5 ml of triamcinolone (at 40 mg/ml) and 1.5 ml of plain bupivacaine (at 0.25%) for a total of 3 ml. After intubation and just prior to tonsillectomy, the study mixture was injected as follows: 1 ml in the inferior pole, 1 ml in the superior pole, and 1 ml just lateral to the tonsillar capsule midway between the two poles. The contralateral side was then injected with a similar amount of normal saline in the same locations. No intravenous steroids were administered during or after the procedure.

During the first 10 days postoperatively, patients were asked to use a visual analog scale to self-evaluate the degree of pain they experienced on each side (figure 1). Once these scales were returned to us, the results were compiled and numerical values were assigned to the responses for statistical analysis.

Results

Five of the 21 patients did not return their scales and were excluded from further study. Among the remaining 16 patients--nine women and seven men, aged 19 to 54 years (mean: 27)--six (37.5%) noted a subjective benefit on the active-treatment side. Three patients felt that their pain was worse on the active-treatment side; however, two of these patients had previously experienced peritonsillar abscesses, and their pre-existing scar tissue made the dissection on the study side more difficult. Overall, we conclude that our method of injecting a preoperative mixture of a steroid and a local anesthetic failed to show any significant alleviation of postoperative pain.

The data were analyzed in accordance with the "generalized estimating equations" (GEE) model, which is an appropriate method given that the correlated data were obtained by repeated measurements. The GEE model is programmed to recognize that multiple observations from each patient are included in the data. Final analysis revealed that while there was very little evidence of a treatment effect (p = 0.83), there was a statistically significant association between decreasing postoperative pain and the passage of time (p<0.000l) (figure 2).

Discussion

Using an individual patient as his or her own control is not a new concept in evaluating post-tonsillectomy pain. Several studies have shown that when surgeons employ a different tonsillectomy technique on each side, patients are able to discern differences in pain intensity on the two sides. (1,15,18,20) Two other advantages of using patients as their own controls include (1) a need for fewer patients in a given study and (2) no need to standardize patients according to their age, weight, pain tolerances, etc., all of which can have an effect on the intensity of postoperative pain.

With the GEE model, we found that the number of assessments reported by our 16 patients was high enough to allow us to make a valid determination of the efficacy of the steroid/anesthetic mixture.

Because two surgeons participated in this study, we were able to achieve our results relatively quickly. Although both surgeons have their own dissection techniques, we believe that this difference had a minimal impact on our overall results; therefore, we did not attempt to control for any possible differences in technique. We did note, however, that the two surgeons had comparable results with respect to the number and degree of postoperative complications.

It is also possible that stratifying our patients by age might have had an impact on our results, and further study in this dimension might add to our understanding of post-tonsillectomy pain relief.

The introduction of alternate operative modalities--including laser, ultrasound, and modified-current electrocautery dissection techniques--holds some promise for shorter operative times and less post-tonsillectomy pain. Future studies will undoubtedly help to refute or substantiate the value of these techniques.

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References

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From the Department of Otolaryngology-Head and Neck Surgery, Madigan Army Medical Center, Tacoma, Wash.

Reprint requests: Timothy M. Cupero, MD, USA MEDDAC-AK, MCUC-ENT, Ft. Wainwright, AK 99703. Phone: [phone]; fax: [phone]; e-mail: [e-mail]

Originally presented at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery; Sept. 26-29, 1999; New Orleans. The opinions and assertions expressed herein are those of the authors and do not necessarily reflect the view of the U.S. Army or the Department of Defense.