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Ann Thorac Surg 2003;76:1055-1058
© 2003 The Society of Thoracic Surgeons


Original article: general thoracic

A prospective, double-blinded, randomized trial evaluating the use of preemptive analgesia of the skin before thoracotomy

Robert James Cerfolio, MD, FACSa,b*, Ayesha S. Bryant, MSPHc, Cynthia Sale Bass, RN, MSNa, Alfred A. Bartolucci, PhDd

a Department of Cardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA
b Department of Cardiothoracic Surgery, Birmingham Veterans Administration HospitalBirmingham, Alabama, USA
c Department of Epidemiology, University of Alabama at Birmingham School of Public Health, Birmingham, Alabama, USA
d Department of Biostatistics, University of Alabama at Birmingham School of Public Health, Birmingham, Alabama, USA

Accepted for publication May 2, 2003.

* Address reprint requests to Dr Cerfolio, Department of Cardiothoracic Surgery, University of Alabama at Birmingham, 1900 University Blvd, THT 712, Birmingham, AL , USA 35294
e-mail: robert.cerfolio{at}ccc.uab.edu


    Abstract
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
BACKGROUND: Thoracic surgeons spend a lot of time treating the pain of thoracotomy.

METHODS: A total of 119 consecutive patients underwent elective thoracotomy. They were prospectively randomized into two groups. One group received an injection of 1% lidocaine with epinephrine in the planned skin incision just before thoracotomy, and the other group received an equal amount of saline and epinephrine. All patients had a functioning preoperative epidural; a skin incision the width of their latissimus dorsi muscle, which was cut; sparing of the serratus anterior muscle; undercutting of the sixth rib; intercostal nerve blocks before rib spreading; a similar number of chest tubes and pulmonary resections; and comparable postoperative pain management. Pain was objectified by a numeric pain score, a visual pain score, and by the Modified McGill pain questionnaire each day in the hospital, and at 3, 6, and 12 months postoperatively.

RESULTS: There were 66 patients in the lidocaine group (L group) and 53 patients in the saline group (S group). Although a trend was noted toward less pain in the L group during the first 3 postoperative days (on the numeric pain scale only) the difference was not statistically significant in overall pain in the hospital or at 3, 6, and 12 months after the operation. Other pain scores and descriptors were similar throughout.

CONCLUSIONS: The injection of lidocaine and epinephrine in the skin just before thoracotomy does not decrease the amount or type of pain during the hospital stay or at 3, 6, and 12 months after surgery.


    Introduction
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
One of the main complaints patients have after thoracotomy is pain, not only in the hospital but also after discharge. General thoracic surgeons spend a lot of time treating this pain and talking to patients about it. Early pain that is not well controlled after surgery can lead to significant complications, such as pneumonia from compromised chest wall mechanics and poor cough effort [1, 2]. Late pain that is not well controlled can also be a difficult problem for patients and surgeons. Some research has shown that chronic pain, defined by some as pain 6 months to 1 year after thoracotomy, may be evident in as many as 44% of patients [3, 4].

Although several studies have examined the problem of pain after thoracotomy [516], few have examined the role of preemptive analgesia of the skin before thoracotomy. Although this concept has been studied in other surgical procedures with good early and late results it has not been evaluated before thoracotomy incision [1720]. Therefore, in this study we performed a prospective, double-blinded, randomized trial to objectively examine the use of preemptive analgesia of the skin before thoracotomy and to evaluate its effect on both early and late pain.


    Material and methods
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Over a 5-month period 119 consecutive patients met the entry criteria for this trial. All patients had an elective pulmonary resection performed by one general thoracic surgeon in a university setting. Exclusion criteria included a history of any of the following conditions: chronic pain syndrome, previous use of methadone, preoperative chest radiation, psychiatric illness, known allergy to lidocaine, or previous ipsilateral thoracotomy. Patients who underwent concomitant chest wall resections were also excluded.

All patients underwent a standard preoperative evaluation. Epidurals were placed before surgery. Once in the operating room patients were anesthetized, intubated, positioned, and prepared. The planned skin incision was marked with a pen on the sterile drape. The pharmacy staff drew up a series of syringes. Five syringes were filled with 1% lidocaine with epinephrine, and another five were filled with normal saline and epinephrine. These syringes were numbered and coded, and the code (recorded by the pharmacist) was not broken until after all the pain data were collected. Because the contents of both sets of syringes were colorless and odorless, the surgical team, the data collector, and the patient were blinded as to treatment group assignment. A maximum dose of lidocaine was calculated based on the patient's weight, and one-half of that dose or of the placebo was injected into the skin. A skin incision was performed 5 minutes later.

All patients had a posterior lateral thoracotomy and all had preoperative epidurals placed. If the epidurals did not function, patients were excluded from this trial. All patients then underwent identical chest opening and closure procedures. The length of each patient's skin incision was equivalent to the width of his or her latissimus dorsi muscle at the level of the sixth rib. This muscle was cut. The underlying serratus anterior muscle was spared, and the chest was entered over the top of the unresected and unshingled sixth rib. Before retracting the ribs, Marcaine (Abbott, South Plainfield, NJ) with epinephrine was injected into the fifth intercostal muscle. We did not dissect out the nerve but injected Marcaine in the muscle bundle proximally. This was done for the fourth, fifth, sixth, seventh, and eighth intercostal muscle and nerve.

An electrocautery was used to undercut the top of the sixth rib from the erector spinae fascia all the way medially to the internal mammary artery. A chest retractor was then placed and slowly opened during the course of the operation in an attempt to avoid rib fracture.

After completion of the appropriate pulmonary resection or procedures, all patients had one or two 28F soft Deknatel (Boston, MA) chest tubes placed. Patients who underwent lobectomy had two tubes placed, and patients who had wedge resection for metastasectomy or segmentectomies received only one chest tube. All patients' chests were closed with intracostal sutures by drilling four small holes in the bed of the sixth rib (as previously described, publication pending). Patients were given similar postoperative pain regimens. The pain service, surgical team, and patient were all blinded to treatment group assignment. Epidural analgesia was used in both groups. The epidural was removed on postoperative day (POD) 2 in all patients, and after that patients were given oxycodone and acetaminophen (Tylox, McNeil Pharmaceutical, Springhouse, PA) as well as ketorolac tromethamine (Toradol, Roche, Nutley, NJ.).

After a statistical power analysis where {alpha} = 0.05 and a power of 80% in a two-sided test, we included 119 patients in this study. Postoperative pain was measured by several different scales. A combination of these scores and scales to achieve the best objective measurement of pain were chosen. We used the Modified McGill pain questionnaire, numeric pain scale, and the visual analog pain scale. Patients were asked to fill out these three surveys each day in the hospital and the amount of pain medicines they used was recorded. If any part of any of the pain surveys were not completely filled out the survey was considered to be incomplete. The Institutional Review Board at the University of Alabama at Birmingham approved this study and patient consent was obtained.

Results are reported as means with standard deviations for continuous variables and as percentages for categorical variables. Categorical variables were compared using either the chi-square or Fisher exact tests. Continuous variables were assessed with the use of nonparametric analyses (Wilcoxon test). A two-sided p value of less than 0.05 was considered statistically significant difference between two groups unlikely to be due to chance. The analysis was performed using SAS v.8.02 software (SAS Institute, Cary, NC).


    Results
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
There were 119 patients in this trial. Sixty-six patients were randomized into the lidocaine (L) group and 53 in the saline (S) group. The groups were matched for age, race, sex, and types of operations (p > 0.05 for all). Additionally we compared potential postoperative confounders such as mean length of stay, mean duration and number of chest tubes, and number of complications and found no significant differences among the two groups (Table 1).


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Table 1. Evaluation of Potential Postoperative Confounders

 
All patients filled out at least part of the pain surveys while in the hospital; 90% of the data points were filled out on average for each patient. However, only 58% completely filled out every part of each survey each POD. Numeric pain scores were completed by 98% of patients during the hospital stay; however, only 65% completed the Modified McGill pain questionnaire each day. After discharge, the percentage of patients who completely filled out all the pain surveys were 88% at 3 months, 82% at 6 months, and 78% at 12 months.

Table 2 shows that although the patients in the L group had a lower mean numeric pain score on PODs 1, 2, and 3, this difference was not statistically significant. We did not analyze the other postoperative days because most patients went home by POD 3 or 4. Table 3 shows a minimal difference between the two groups for most of the McGill pain descriptors. However, the few descriptors that were significantly different all favored the L group. Table 4 shows that there was no difference in the visual analog scores between the two groups.


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Table 2. Mean Numeric Pain Scores After Thoracotomy

 

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Table 3. p Values Comparing the L Group to the S Group for the Modified McGill Questionnaire Descriptors After Thoracotomy

 

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Table 4. Visual Analog Pain Scale

 

    Comment
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Any pain study is plagued by the inherently subjective nature of pain. We sought the best pain scores and scales possible, but still pain is difficult to objectify. Because of the difficulty of studying pain in a controlled fashion we planned a single institutional study, with only one surgeon, with similar preoperative, intraoperative, and postoperative techniques and management. We used the same type of analgesics in both groups, and had the same personnel managing both groups of patients. We varied only one specific part of the operation. We performed a double-blinded, prospective, randomized trial and found no significant difference between two matched groups.

We learned some valuable lessons for future studies on pain. Obtaining pain scores from elderly patients while in the hospital after a thoracotomy is difficult. The compliance rate for completing the entire survey was much lower during the hospital stay than after the patient was released home. This is because patients are often too tired or too weak to fill out long surveys on their own, and their family members try to help them. We found that even the Modified McGill pain survey, which is a condensed version of the much lengthier McGill pain survey, is too cumbersome and may be best suited for chronic and not acute pain. Moreover, we found that even trying to record the amount of pain medicines that patients use while in the hospital may also be inaccurate, because oftentimes family members are pressing the patients' controlled analgesia buttons. Therefore, these data were discarded and not analyzed in this study.

We found that the level of pain patients experienced was influenced by the time of the day the survey was done with respect to their recent activity and dosing of oral pain medicines. This difference was much greater while in the hospital as opposed to after discharge. The visual analog scale was difficult for patients to complete consistently; therefore, we are not including this scale in our ongoing pain studies.

The concept of preemptive analgesia is not new. Interestingly, injecting local anesthesia in the skin in a patient under general anesthesia may help decrease long-term pain despite lidocaine's half-life of only 1.5 to 2 hours. Several possible reasons may explain why our trial failed to show a consistent difference in pain between the two groups at 3, 6, and 12 months. First and most important is perhaps that the idea of preemptive analgesia of the skin does not work as well in the chest as it does in other areas of the body [16–21]. This may be because most of the pain of thoracotomy is secondary to the intercostal nerve and not from the skin. It also may be because the pain of thoracotomy has a visceral component that local anesthesia cannot control. Preemptive injection of the intercostal nerve may be another area that needs to be further studied, but ensuring proper injection before surgery may be difficult. A final possibility why our study did not show a difference is that we did not have enough patients. This may explain why we found only a trend but not a statistically significant difference.

In summary, the injection of lidocaine in the skin before posterolateral thoracotomy does not seem to decrease the pain during the hospital stay or at 3, 6, or 12 months postoperatively. Therefore, we do not currently recommend its use. More studies are needed before the idea of preemptive analgesia of the skin or of the intercostal nerve before thoracotomy is rejected.


    References
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 

  1. Sabanathan S., Eng J., Mearns A.G. Alterations in respiratory mechanics following thoracotomy. J R Coll Surg Edinb 1990;35:144-150.[Medline]
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  5. Hazelrigg S.R., Landreneau R.J., Boley T.M., et al. The effect of muscle-sparing versus posterolateral thoracotomy on pulmonary function, muscle strength, and postoperative pain. J Thorac Cardiovasc Surg 1991;101:394-401.[Abstract]
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  8. Landreneau R.J., Hazelrigg S.R., Mack M.J., et al. Postoperative pain-related morbidity: video-assisted thoracic surgery versus thoracotomy. Ann Thorac Surg 1993;56:1285-1289.[Abstract]
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  12. Cerfolio RJ, Price TN, Bryant AS, Bass CS, et al. Intra-costal sutures decrease the pain of thoracotomy. (Publication pending)
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