ORIGINAL ARTICLE ISSN 1598-1703 (Print) ISSN 2287-6782 (Online) Korean J Endocrine Surg 2013;13:257-261 The Korean Journal of Endocrine Surgery 액와접근법을이용한무기하내시경갑상선절제술후국소부위통증조절장치 (On-Q R PainBuster R ) 와자가통증조절장치의무작위대조연구에대한예비자료 성균관대학교의과대학강북삼성병원유방갑상선암센터이경원ㆍ박찬흔ㆍ박용래ㆍ현기훈ㆍ윤지섭 A Preliminary Study for Randomized, Controlled Trial of On-Q R PainBuster R Pain Pump vs. Intravenous Patient-controlled Analgesia after Gasless Transaxillary Endoscopic Thyroidectomy Purpose: Gasless transaxillary approach to endoscopic thyroidectomy is a widely performed procedure for benign or malignant thyroid neoplasms. However, it requires wide dissection for approaching the target area. The intravenous patient-controlled analgesia (IV PCA) is an effective method for postoperative pain control and patients can use it according to their requirement. However, patients suffer from nausea, vomiting, sleep disturbance, etc. due to opioids. Pain pump ON-Q R PainBuster R (pain buster) has been used widely in various surgeries for control of postoperative localizing and wide area pain without side effects of opioid analgesia because it consists of Ropivacaine. Methods: From Aug. 2008 to Jan. 2013, Gasless transaxillary endoscopic thyroidectomy was performed in 90 patients in a single institution, who were divided into three groups, including the IV PCA, pain buster, and null groups. We compared postoperative outcomes, pain severity between groups. We recorded scores immediately, 6, 12, 24, and 48 hours after surgery following visual analog pain score (VAS), and investigated hospital stay and occurrence of events of nausea, vomiting, and complications. Results: In the IV PCA group, it was discontinued due to nausea in 36.7% of patients. No significant difference in pain severity following VAS score was observed among the three groups. However, smaller numbers of analgesia injections were required in the Pain buster group than in the other groups, and fewer patients suffered from constipation, compared with the PCA group. Conclusion: Pain buster showed even effects compared to IV PCA, with few side effects and less discomfort of patients, compared with the other groups. Therefore, pain buster was thought to be the proper method for pain control after dissection of the anterior chest wall, cervical area in order to secure an operative view for transaxillary endoscopic thyroidectomy. Key Words: Endoscopic thyroidectomy, Gasless transaxillary approach, Postoperative pain control 중심단어 : 내시경갑상선절제술, 무기하액와접근법, 수술후통증조절 Kyung-Won Lee, Chan-Heun Park, Yong-Lai Park, Ki-Hun Hyun, Ji-Sup Yoon Breast-Thyroid Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea Received October 18, 2013, Revised November 20, 2013, Accepted November 20, 2013 Correspondence: Ji-Sup Yoon Department of Surgery, Breast-Thyroid Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 108 Pyong-dong, Jongro-gu, Seoul 110-746, Korea Tel: +82-2-2001-2132, 3 Fax: +82-2-2001-2131 E-mail: jisup.yun@samsung.com Copyright 2013 Korean Association of Thyroid and Endocrine Surgeons; KATES. All Rights Reserved. cc This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
258 Korean J Endocrine Surg 2013;13:257-261 journal.kates.or.kr 서론 액와접근법을이용한무기하내시경갑상선절제술은여러연구에서유용성과안정성이입증되었으며고식적갑상선절제술과비교하였을때우수한미용적효과를보인다.(1-4 ) 그러나수술에필요한공간확보를위해액와부부터갑상선에이르기까지넓은조직박리가필요하며이에따라발생할수있는통증의조절은환자의삶의질측면에서중요한문제이다.(5 ) 이전의연구결과들을살펴보면액와접근법을이용한무기하내시경갑상선절제술은고식적갑상선절제술에비해통증의강도는덜하나 35 65% 환자들이중등도에서고도의경부혹은전흉부통증을호소한다.(6,7 ) 자가통증조절장치 (Intravenous patientcontrolled analgesia; PCA) 는수술후통증조절에강력한도구로환자가스스로진통의정도따라적정량의진통제를투여할수있는장점이있다.(8 ) 그러나마약성진통제를사용하여야기되는오심, 구토, 수면장애, 변비등의부작용이동반되어환자의불편을야기한다.(9 ) 국소부위통증지속조절장치 ON-Q R PainBuster R (painbuster) 는 Ropivacaine을사용하여마약성진통제에의한부작용이없다.(10 ) 또한카테터를사용하여박리부위에직접적으로지속적인약물주입을하기때문에광범위영역에국소적통증조절이가능하다.(11 ) 따라서넓은조직박리가필요한무기하내시경갑상선절제술에적합한국소적통증조절방법으로생각된다. 방법 본연구는전향적무작위공개임상연구로써 2012년 8월부터 2013년 1월까지성균관대학교의과대학강북삼성병원유방갑 상선암센터에서시행한액와접근법을이용한무기하내시경갑상선절제술환자 90명을대상으로자가통증조절장치군과국소부위통증조절장치군, 그리고대조군으로나누어수술후경과와합병증발생을비교하였다. 자가통증조절장치군은자가통증조절장치 (Accufuser Plus R ; Wooyoung Medical, Seoul, Korea) 에연결하여정맥주사로투여되었다. 정맥용자가통증조절요법은 2 mg fentanyl과 120 mg ketorolac 1.5 mg fentanyl 그리고생리식염수총용량 100 ml으로혼합하였다. 정맥용 PCA의유지용량, 급속정맥주사 (IV bolus) 용량, 중지 (lockout) 간격은 1 ml/h, 1 ml, 15분이었다. 국소부위통증조절장치 (On-Q pain buster; I-Flow Corp., Lake Forest, CA; distributed by Ethicon Endo-Surgery, Inc., Cincinnati, OH) 군은무기하경액와내시경갑상선절제술중갑상선절제후지혈과배액관삽입후피부봉합전카테터를삽입한다 (Fig. 1). 카테터의끝의위치는약제가되돌이후두신경에닿지않도록경정맥앞까지만위치시킨다 (Fig. 2). 카테터를피부에고정시킨후 Ropivacaine 0.75%, 20 ml를 bolus 주입한다 (Fig. 3). 이후카테터를국소부위통증조절장치펌프에연결한다. 펌프에혼합되는약제는 Ropivacaine 0.75% 60 ml와생리식염수 (40 ml), 총 100 ml로하루투여양은 600 mg이된다. 대조군은자가통증조절장치와국소부위통증조절장치를둘다사용하지않고 ibuprofen 200 mg을하루 3회투여하였다. 세군의환자들모두각각의통증조절로도통증이조절되지않아환자가통증조절을원할때 tramadol 50 mg/ml가정맥주사로투여되었고이의횟수를기록하였다. 통증조절의효과조사는 통증없음 0에서 상상할수있는가장강한통증 10점까지의 VAS 점수를통해수술직후, 수술 Fig. 1. Insertion on the catheter of On-Q R PainBuster R pain pump during gasless transaxillary endoscopic thyroidectomy. Fig. 2. Placing the catheter - Use forceps to the end of the flap until ropivacaine should not reach to recurrent laryngeal nerve.
이경원외 : Pain Pump vs. Intravenous PCA after Gasless Transaxillary Endoscopic Thyroidectomy 259 후 6, 12, 24, 48시간에환자자가평가를통하여점수를기록하였다. 오심은정도에따라오심이없는경우 grade 0; 특별한치료없이관찰후경과가좋아진경우 grade 1; 자가통증조절장치나국소부위통증조절장치를중지해야하는경우 grade 2; 환자의요구로치료 (intravenous metoclopramide 10 mg) 가필요한정도 grade 3로나누어이의평균을조사하였다. 그리고재원일수, 변비, 출혈등의합병증발생여부를조사하였다. 1) 통계분석정성적변수는 Fisher 정확검정을시행하였다. 정규분포정량적변수는 Student T 검정을시행하였고, 비정규분포정량적 Fig. 3. Bolus injection of ropivacaine (0.75%, 20 ml). 변수는 Mann-Whitney U 검정을시행하였다. 세그룹의 VAS 점수변화의차이를확인하기위하여상호작용 P 값 (interaction P value) 을살펴보았다. 모든통계분석은 IBM SPSS Statistics 21.0 (IBM, Armonk, New York, USA) 을사용하였고, P<0.05 인경우통계적유의성이있는것으로상정하였다. 결과 총 90명의환자중대조군의 1명만제외하고모두여성이었다. 환자들의평균연령은 40.1세이며대조군이 39.2세로젊었으나통계적유의성은없었다. 세군간의특성은수술시간만국소부위통증조절장치군이 68.27±13.26분 (P=0.002) 10분내외로길게걸린것을제외하고유의한차이는없었다 (Table 1). 각군의수술후결과를살펴보았을때자가통증조절장치군에서다른두군에비해유의하게변비를호소하는환자가많았다 ( 자가통증조절장치군 7명 23.3% P=0.011). 오심의정도역시자가통증조절장치군은평균 1.37±1.42로국소부위통증조절장치군 0.17±0.46 그리고대조군 0.03±1.83에비해유의하게높았다 (P<0.001). 오심호소나환자의요구에의해통증조절방법을중단한경우는자가통증조절장치군에서 11명 (36.7%) 으로매우높았으며국소부위통증조절장치군에서는모든환자에서특별한불편감호소는없었다 (P<0.001). 추가적으로정맥진통제를투여한환자는자가통증조절장치군 17명, 국소부위통증조절장치군 9명, 그리고대조군은 30명이었다 (Table 2). VAS 점수를조사한결과세군간의통계적으로유의한차이는 Table 1. Patients characteristics Age (years) 41.8 40.3 39.2 0.781 Sex (M:F) 0:30 0:30 1:29 Height (cm) 159.78±4.12 158.93±4.60 159.77±5.85 0.746 Weight (kg) 56.72±8.95 58.61±8.49 60.48±7.56 0.226 Operation Hemi-thyroidectomy 20 (66.66%) 24 (80.0%) 22 (73.33%) 0.296 Total-thyroidectomy 10 (33.33%) 6 (20.0%) 8 (26.66%) Operation time (min) 57.67±11.27 68.27±13.26 60.00±15.53 0.002 Table 2. Patients outcomes Hospital stay (day) 2.73±0.64 2.80±0.79 2.79±0.62 0.824 Nausea (mean grades) 1.37±1.42 0.17±0.46 0.03±1.83 <0.001 Withdrawal 11 (36.7%) 0 0 <0.001 Constipation 7 (23.3%) 0 1 (3.34%) 0.011 Additional pain medication 17 (56.7%) 9 (30%) 30 (100%) 0.04
260 Korean J Endocrine Surg 2013;13:257-261 journal.kates.or.kr Table 3. VAS score Post operation 4.53±1.38 4.97±2.29 4.63±1.15 0.178 6 hr 2.63±0.96 2.50±0.93 3.07±0.74 0.093 12 hr 2.17±0.83 2.03±0.92 2.53±0.90 0.094 24 hr 1.83±1.17 1.87±0.90 2.10±1.18 0.115 48 hr 0.80±1.09 0.87±0.81 1.13±1.00 0.103 Fig. 4. Graph of visual analogue pain scores. 없었으나자가통증조절장치군과국소부위통증조절장치군이대조군보다수술후 6시간부터호소하는 VAS 점수가조금씩더낮은수치를보였다 (Table 3, Fig. 4). 고찰 갑상선암은여성에서호발하는질환이기때문에미용적문제에따른삶의질의중요성이크다. 1996년최초내시경적부갑상선아전절제술을발표한이후에갑상선영역에서내시경의비약적인발전을이루었다.(12-14 ) 특히액와접근법을이용한무기하내시경갑상선절제술은갑상선의측면에서접근하여시야를확보하기때문에고식적경부절개술후의수술시야와동일한상태로수술을진행할수있다. 이의가장뛰어난장점은중요해부학적구조를보존하는데유리하며넓은수술시야를확보할수있고중앙경부림프절절제술이용이하다는점이다.(14 ) 그러나이수술공간을확보하기위해액와부에서부터갑상선까지넓은영역의박리와피판의견인이필요하다. 따라서이에뒤따르는통증은환자의삶의질에있어중요한해결과제이다. 국소부위통증지속조절장치 ON-Q R PainBuster R 는카테터를통하여지속적으로넓은영역에진통제를투여할수있기때문에이러한넓은피판의통증조절에있어적절한방법으로생각된다.(15,16 ) 여러종류의수술분야에서국소부위통증지속조절장치의적용연구가시행되었다. Givens 등은제왕절개수 술후모르핀의사용이 40% 줄었음을보고했고 Morrison 등도유방절제술에서 68% 의진통제사용감소를보고했다.(17,18 ) 특히근치적액와부임파선곽청술을시행한환자에서국소부위통증지속조절장치의이중맹검무작위임상연구에서 ON-Q R PainBuster R 를사용한그룹에서유의한통증의감소와마약성진통제사용감소, 오심과구토의감소를보인결과는우리의가설을뒷받침해준다.(19 ) 본연구에서는국소부위통증조절장치와큰수술 (major operation) 시자주사용하는통증조절인자가통증조절장치, 그리고둘다사용하지않은대조군의세군을비교하였다. 자가통증조절장치의가장빈번한합병증은마약성진통제에의한오심으로이전의연구결과발표에서자가통증조절장치에의한오심은 30%, 고위험환자에서는 79% 까지보고되었다.(20,21 ) 본연구도이와유사한결과를보이며자가통증조절군에서환자의 11명 (36.7%) 에서오심의부작용으로사용을중단하였다. 이는경제적측면에서환자에게큰부담이되는동시에수술후불편감을오히려증가시키게되었으며결과적으로다른두군에비해효과적이지못한진통방법이라생각된다. 국소부위통증조절장치는자가통증조절장치에서발생하는마약성진통제연관합병증의발생없이환자들이편안하게통증조절이되었고통계적유의성은떨어지나대조군에비해서도낮은수술후 VAS 점수를보였다. 대조군의통증조절은 ibuprofen 200 mg의하루 3회복용외에환자가통증을호소하여필요할때마다추가적인 tramadol 정주를한것이다. 그러나대조군의모든 30명의환자가정주진통제를투여하였고결과적으로국소부위통증조절장치에비해환자들의통증의호소횟수가많았다. 또한추가적인정맥주사를위하여정맥주사용통로를유지해야하는불편과이에따른염증등의합병증이발생할수있다. 본연구는액와접근법을이용한무기하내시경갑상선절제술에서국소부위통증지속조절장치의유용성을알아본첫연구이나, 무작위연구였음에도불구하고공개임상연구로진행되어이에따른편향 (bias), 그리고환자들의총비용에대한집계가이뤄지지않아경제적효과의비교가되지못하였다는한계점이있다. 본연구결과국소부위통증지속조절장치 (ON-Q R
이경원외 : Pain Pump vs. Intravenous PCA after Gasless Transaxillary Endoscopic Thyroidectomy 261 PainBuster R ) 는적은부작용으로자가통증조절장치와같은통증조절효과를보이며대조군과자가통증조절장치군에비하여환자들의불편호소가적었다. 따라서액와접근법을이용한갑상선내시경수술후절개창, 수술공간을확보하기위해박리를진행한전흉부, 경부의국소적통증조절에유용한방법으로적용할수있다. 향후더많은수의환자를대상으로한맹검검사와비용효과에대한평가가필요할것으로생각된다. REFERENCES 1. Miccoli P, Bellantone R, Mourad M, Walz M, Raffaelli M, Berti P. Minimally invasive video-assisted thyroidectomy: multiinstitutional experience. World J Surg 2002;26:972-5. 2. Lombardi CP, Raffaelli M, de Crea C, Princi P, Castaldi P, Spaventa A, et al. Report on 8 years of experience with video-assisted thyroidectomy for papillary thyroid carcinoma. Surgery 2007;142:944-51. 3. Chung YS, Choe JH, Kang KH, Kim SW, Chung KW, Park KS, et al. Endoscopic thyroidectomy for thyroid malignancies: comparison with conventional open thyroidectomy. World J Surg 2007;31:2302-6. 4. Jeong JJ, Kang SW, Yun JS, Sung TY, Lee SC, Lee YS, et al. Comparative study of endoscopic thyroidectomy versus conventional open thyroidectomy in papillary thyroid microcarcinoma (PTMC) patients. J Surg Oncol 2009;100:477-80. 5. Kang SW, Jeong JJ, Yun JS, Sung TY, Lee SC, Lee YS, et al. Gasless endoscopic thyroidectomy using trans-axillary approach; surgical outcome of 581 patients. Endocr J 2009;56:361-9. 6. Duncan TD, Rashid Q, Speights F, Ejeh I. Endoscopic transaxillary approach to the thyroid gland: our early experience. Surg Endosc 2007;21:2166-71. 7. Ikeda Y, Takami H, Sasaki Y, Takayama J, Niimi M, Kan S. Clinical benefits in endoscopic thyroidectomy by the axillary approach. J Am Coll Surg 2003;196:189-95. 8. Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg 2002;10:117-29. 9. Oh JH, Kim WS, Kim JY, Gong HS, Rhee KY. Continuous intralesional infusion combined with interscalene block was effective for postoperative analgesia after arthroscopic shoulder surgery. J Shoulder Elbow Surg 2007;16:295-9. 10. Pontarelli EM, Matthews JA, Goodhue CJ, Stein JE. On-Q R pain pump versus epidural for postoperative analgesia in children. Pediatr Surg Int 2013. 11. Gebhardt R, Mehran RJ, Soliz J, Cata JP, Smallwood AK, Feeley TW. Epidural versus ON-Q local anesthetic-infiltrating catheter for post-thoracotomy pain control. J Cardiothorac Vasc Anesth 2013;27:423-6. 12. Gagner M. Endoscopic subtotal parathyroidectomy in patients with primary hyperparathyroidism. Br J Surg 1996;83:875. 13. Chao TC, Lin JD, Chen MF. Gasless video-assisted total thyroidectomy in the treatment of low risk intrathyroid papillary carcinoma. World J Surg 2004;28:876-9. 14. Yoon JH, Park CH, Chung WY. Gasless endoscopic thyroidectomy via an axillary approach: experience of 30 cases. Surg Laparosc Endosc Percutan Tech 2006;16:226-31. 15. Stringer NH, Rodino KL, Edwards M, Kumari NV. On-Q system for managing trocar site pain after operative laparoscopy. J Am Assoc Gynecol Laparosc 2000;7:552-5. 16. Baig MK, Zmora O, Derdemezi J, Weiss EG, Nogueras JJ, Wexner SD. Use of the ON-Q pain management system is associated with decreased postoperative analgesic requirement: double blind randomized placebo pilot study. J Am Coll Surg 2006;202:297-305. 17. Givens VA, Lipscomb GH, Meyer NL. A randomized trial of postoperative wound irrigation with local anesthetic for pain after cesarean delivery. Am J Obstet Gynecol 2002;186:1188-91. 18. Morrison JE Jr, Jacobs VR. Reduction or elimination of postoperative pain medication after mastectomy through use of a temporarily placed local anesthetic pump vs. control group. Zentralbl Gynakol 2003;125:17-22. 19. Schell SR. Patient outcomes after axillary lymph node dissection for breast cancer: use of postoperative continuous local anesthesia infusion. J Surg Res 2006;134:124-32. 20. Apfel CC, Läärä E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology 1999;91:693-700. 21. Watcha MF, White PF. Postoperative nausea and vomiting. Its etiology, treatment, and prevention. Anesthesiology 1992;77: 162-84.