ORIGINAL ARTICLE

Prospective, randomized controlled trial on use of ropivacaine after robotic thyroid surgery: Effects on postoperative pain Dong Sik Bae, MD,1 Su-jin Kim, MD, MS,2 Do Hoon Koo, MD, PhD,1 Se-Hyun Paek, MD, MS,2 Hyungju Kwon, MD, MS,2 Young Jun Chai, MD, MS,3 June Young Choi, MD, MS,4 Kyu Eun Lee, MD, PhD,2* Yeo-Kyu Youn, MD, PhD2 1

Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea, 2Department of Surgery, Seoul National University College of Medicine and Hospital, Cancer Research Institute, Division of Surgery, Thyroid Center, Seoul National University Cancer Hospital, Seoul, Korea, 3Department of Surgery, Seoul National University Boramae Medical Center and College of Medicine, Seoul, Korea, 4Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea.

Accepted 6 March 2015 Published online 6 July 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/hed.24045

ABSTRACT: Background. We evaluated the effects of ropivacaine for pain relief after robotic thyroid surgery. Methods. One hundred eight patients scheduled for robotic thyroid surgery were randomized into ropivacaine (n 5 54) or control (n 5 54) groups. After surgery, 40 mL of 0.25% ropivacaine or 0.9% saline (control) was instilled into the skin flap. Postoperative pain intensity (visual analog scale [VAS]), analgesic requirements (fentanyl), and adverse events were assessed at 1, 2, 4, 8, 16, and 24 hours postoperatively. Results. One hundred three patients completed the study protocol. VAS scores were lower in the ropivacaine group than the control group

INTRODUCTION Since endoscopic neck surgeries were first introduced by Gagner1 in 1996, various endoscopic techniques for thyroid surgery have been developed.2–4 Endoscopic thyroidectomy has several advantages over conventional open thyroidectomy, including superior cosmetic results, a quicker return to normal activity, and a better operative view with magnification.5–8 However, endoscopic thyroidectomy has some limitations, as it is difficult to obtain an adequate operative view and perform meticulous dissections in the operative field as a result of the small working space. Furthermore, the instruments used in endoscopic thyroidectomy can be inadequate. The introduction of robotic systems in thyroid surgery has enabled an easy and highly precise manipulation of instruments in the small working space of the neck.9,10 Given these advantages, robotic systems have been widely adopted for thyroid surgery and include remoteaccess methods, such as the gasless transaxillary approach or bilateral axillo-breast approach (BABA).11,12 Since

*Corresponding author: K. E. Lee, Department of Surgery, Seoul National University Hospital and College of Medicine, Cancer Research Institute, Seoul National University College of Medicine, Division of Surgery, Thyroid Center, Seoul National University Cancer Hospital, 101 Daehangno, Jongno-gu, Seoul, 110–744, Republic of Korea. E-mail: [email protected] Dong Sik Bae and Su-jin Kim contributed equally to this work.

E588

HEAD & NECK—DOI 10.1002/HED

APRIL 2016

(p 5 .010); however, VAS scores were not significantly different after 8 hours postoperatively. Total analgesic consumption was higher in controls than ropivacaine-treated patients (p 5 .01). Adverse events did not differ between the 2 groups. Conclusion. Ropivacaine instillation after robotic thyroid surgery reduces acute postoperative pain and analgesic requirements without adverse C 2015 Wiley Periodicals, Inc. Head Neck 38: E588–E593, 2016 events. V

KEY WORDS: acute pain, ropivacaine, robotic thyroid surgery, postoperative pain, bilateral axillo-breast approach (BABA)

2004, we have been performing BABA endoscopic thyroidectomy for benign and malignant tumors,13 and a da Vinci Robotic System (Intuitive Surgical, Mountain View, CA) has been applied for endoscopic thyroidectomy since 2008.12 BABA robotic thyroid surgery provides surgical and oncologic safety with excellent cosmetic outcomes.14,15 However, there are concerns regarding postoperative pain after BABA robotic thyroid surgery because the remote-access method requires additional flap dissection to establish an operative field when compared with that of a conventional open thyroidectomy. Thus, we performed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of ropivacaine instillation into the skin flap for postoperative pain control. Surgical outcomes and adverse events associated with ropivacaine instillation were also analyzed.

PATIENTS AND METHODS This prospective study was performed in the Department of Surgery, Seoul National University Hospital (Seoul, Korea). The study protocol was approved by the Institutional Ethics Committee of Seoul National University (H-11105-116-364). This clinical trial was registered at the Clinical Research Information Service: KCT0001085 (https://cris.nih.go.kr/cris). One hundred eight patients who were scheduled for BABA robotic thyroid surgery agreed to participate in the

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present study, which was performed from March 2012 to December 2012. Written informed consent was obtained from all patients before randomization. Patients were not admitted to this study if any of the following criteria were present: known or suspected allergy, hypersensitivity, or contraindication to amide local anesthetics. Furthermore, patients with the following medical conditions were excluded: pregnant or breast feeding, history of liver or heart problems, low blood pressure (systolic blood pressure

Prospective, randomized controlled trial on use of ropivacaine after robotic thyroid surgery: Effects on postoperative pain.

We evaluated the effects of ropivacaine for pain relief after robotic thyroid surgery...
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