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JAMA Facial Plastic Surgery | Original Investigation Occurrence of , , and Pain in Upper Blepharoplasty Using Blunt-Needle vs Sharp-Needle Anesthetic Injection in Upper Blepharoplasty A Randomized Clinical Trial

Wenxin Yu, MD; Yunbo Jin, MD; Jingyan Yang, MHS; Gang Ma, MD; Yajing Qiu, MD; Hui Chen, MD; Xi Yang, MD; Lei Chang, MD; Xiaoxi Lin, MD, PhD

Supplemental content IMPORTANCE Though it has been a common practice to use sharp needles to administer local anesthesia for upper blepharoplasty, the evidence for their benefit is lacking.

OBJECTIVE To evaluate whether there is any benefit of using blunt-needle injection for local anesthesia when performing upper blepharoplasty to reduce postoperative bruise, hematoma, and pain.

DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of 44 patients who underwent bilateral upper blepharoplasty in an academic medical setting were randomized to receive local anesthesia injections (lidocaine, 2%; 27-gauge needle) with a blunt needle in one eyelid and a sharp needle in the other eyelid.

MAIN OUTCOMES AND MEASURES Visual analog scale (VAS) score of 0 to 10 (lower score indicating lower level of pain) was used to blindly assess pain in patients receiving anesthesia injections with both needle types. After injection and skin incision, photographs of the eyelids of each patient were taken and used by 2 blinded observers to identify bruise or hematoma.

RESULTS In the 44 patients (88 eyelids) included in the study (all women; mean age, 31 years; age range, 18-56 years) bruise or hematoma occurred at the sharp-needle injection site in 11 women (25%) vs 0 women at the blunt-needle site (P < .001). The mean VAS scores were 5.48 and 4.64 for pain assessed at sites of sharp- and blunt-needle injections, respectively (P = .002).

CONCLUSIONS AND RELEVANCE Use of blunt needles to administer local anesthesia when performing upper blepharoplasty is less likely to cause hemorrhage and require interventional pain procedures than use of sharp needles. Therefore, for a more accurate surgical procedure and faster recovery, a blunt needle may be a preferable choice. The use of the blunt needle presents fewer complications and allows more accurate and refined work with faster patient recovery.

LEVEL OF EVIDENCE 1. Author Affiliations: Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Plastic TRIAL REGISTRATION Chinese Clinical Trial Registry identifier: ChiCTR-ONC-16007979 and Reconstructive Surgery, Shanghai, China (Yu, Jin, Ma, Qiu, Chen, X. Yang, Chang, Lin); Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York (J. Yang). Corresponding Author: Xiaoxi Lin, MD, PhD, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Department of Plastic and Reconstructive Surgery, No. 639 JAMA Facial Plast Surg. 2017;19(2):128-132. doi:10.1001/jamafacial.2016.1376 Zhizaoju Road, Shanghai, Shanghai Published online November 23, 2016. Corrected on March 16, 2017. 200011, China ([email protected]).

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lepharoplasty, one of the most common surgical pro- cedures performed by plastic surgeons, can improve Key Points dermatochalasis, a common condition of excess skin B Question Is there a difference between occurrence of hematoma hanging over the upper eyelids or even beyond the eyelashes, and pain in upper blepharoplasty using blunt- vs sharp-needle mostly caused by aging.1 In Asian patients, in particular, double injection of local anesthesia? eyelid plasty, also known as Asian blepharoplasty or double Findings In this randomized clinical trial of 44 women who eyelid surgery, is frequently performed together with epican- underwent blepharoplasty with sharp-needle anesthesia injection thoplasty to create a superior eyelid with a crease and re- in one eyelid and blunt-needle injection in the other, hematoma move the epicanthal fold in Asian upper eyelids. The surgical occurred at the sharp-needle site in 11 patients (25%) vs 0 patients procedure creates an illusion of larger, more relaxed eyes and at the blunt-needle site. The mean visual analog scale pain scores has become one of the most common cosmetic procedures in were 5.48 and 4.64 at the sharp- and blunt-needle sites, Asia.2-4 respectively. Conventional sharp needles (Figure 1) have been widely Meaning The use of blunt-needle injection for anesthesia used to administer local anesthesia injections in upper blepha- administration in upper blepharoplasty may cause fewer roplasty. However, blunt needles have been considered complications and allow more accurate and refined work with (Figure 1) because they are less prone than sharp ones to pro- faster patient recovery. duce from unintended entry into blood vessels.5 Hence, many surgeons use blunt-tip microcannula devices to avoid inadvertent penetration of adjacent vital structures or Figure 1. Sharp Needle (Left) vs Blunt Needle (Right) arteries during surgery.6 In previous studies, complications resulting from hema- toma and interventional pain procedures have raised the is- sue of improved safety when using blunt needles instead of sharp needles in these procedures.7 To our knowledge, this is the first prospective, side-by-side comparison study to evalu- ate potential advantages of blunt-needle use on complica- tions such as incidence of bruise and/or hematoma and need for interventional pain procedures. Specifically, by using both 1 blunt and 1 sharp needle to inject local anesthesia into con- tralateral eyes of each patient undergoing upper blepharo- plasty, we evaluated whether the blunt needles reduced com- plications of upper blepharoplasty compared with the sharp ones.

Methods

This prospective, observer-blinded, randomized clinical trial right, of patients assigned odd numbers. Sharp needles were was approved by the investigational review board of the Shang- used in the left eye, blunt needles in the right, of patients hai Ninth People’s Hospital. All patients provided their writ- assigned even numbers. Upper blepharoplasties were ten informed consent. The study protocol is available in the performed by a plastic surgeon at the Shanghai Ninth People’s Supplement. We recruited study participants from October Hospital. 2014 through October 2015 among patients throughout the Shanghai Ninth People’s Hospital who were scheduled for bi- Interventional Pain Procedures lateral upper blepharoplasty (Figure 2). Patients who had un- To assess the difference in need for interventional pain pro- dergone previous surgery on the upper eyelids were ex- cedures between the use of blunt and sharp needles for cluded. local anesthesia injections, patients were asked to score the Prior to the operation, local anesthesia (lidocaine, 2%) pain of both upper eyelids, without knowing which needle was injected into both eyelids of each patient using a blunt was used in which, by means of a visual analog scale (VAS) needle (27-gauge, 2 inches long [50 mm]) for one upper eye ranging from 0 (no pain at all) to 10 (unbearable pain). lid and a sharp needle (27-gauge, 1.4 inches long [35 mm]) This score was used to measure the pain in eyes receiving for the other eyelid. The selection of each upper eyelid to be local anesthesia injections with each type of needle injected with either needle type was determined by a ran- (Figure 3A). domization procedure: when the random sequence soft- ware was applied (http://www.dxy.cn/bbs/topic/21117904), it Bruise and/or Hematoma produced a randomized number sequence from 1 to xx; A bruise and/or hematoma is caused by blood from a broken then random sequence numbers were assigned to the patients. blood vessel that has accumulated under the skin, a mass of Blunt needles were used in the left eye, sharp needles in the blood in the as a result of trauma, or other factors that

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Figure 2. Participant Enrollment, Randomization, and Analysis Figure 3. Illustrations of Pain and Hematoma Assessments in Anesthesia Administration by Blunt vs Sharp Needles 73 Patients screened in Upper Blepharoplasty Procedure

A Pain B Hematoma 52 Eligible Hematoma 10 50 No hematoma

52 Enrolled who underwent bilateral upper blepharoplasty 8 40

8 Excluded for lack of pain evaluation 6 30

4 20 Patients, No. 44 (88 eyes) Underwent side-by-side randomization Visual Analogue Scale 2 10

0 0 44 Eyes local anesthesia 44 Eyes local anesthesia Blunt Needle Sharp Needle Blunt Needle Sharp Needle (lidocaine 2%) in a upper eyelid (lidocaine 2%) in the other upper using a blunt needle (27-gauge) eyelid using a sharp needle each patient (27-gauge) each patient A, The mean visual analog scale pain scores were 5.48 and 4.64 (error bars indicate SD) for sharp and blunt needles, respectively (P = .002). B, The incidence of hematoma produced by blunt (0 of 44) and sharp needles (11 of 44) was ascertained by direct visualization of the surgical and evaluation of photographs (P < .001). 44 Patients used visual analog scale to evaluate pain in each eye without knowing Whether blunt or sharp needle wore used

44 Photographs of the eyelids of each patient Results were taken and evaluated blindly by 2 observers to identify hematoma A total of 52 patients were included in this study who were evaluated for the occurrence of hematoma, but 8 patients were excluded because of lack of pain evaluation. Finally, there were 44 patients who underwent the full study analysis. All 44 pa- cause the rupture of blood vessels. When blood vessels are tients (100%) were women whose ages ranged from 18 to 56 injured by a needle, localized subcutaneous bleeding can years (mean age, 31 years). lead to red or dark red spots. The difference between the incidence of bruise and/or hematoma at the sites of local Interventional Pain Procedures anesthesia injections given to study patients by using a To assess the pain produced by the use of blunt and sharp blunt needle for one upper eyelid and a sharp needle for the needles for local anesthesia injections in upper blepharo- other was assessed by photographic evaluation. Immedi- plasty, the patients self-evaluated their pain by assigning it a ately after injection (Figure 4A) and again after skin incision VAS score from 0 (no pain) to 10 (worst pain). The mean (SD) (Figure 4B), photographs of both eyelids were taken. Photo- VAS scores were 5.48 (1.59) and 4.64 (1.67) for sharp and blunt graphic evaluation was performed by 2 plastic surgeons needles, respectively (Figure 3A). The difference in VAS scores who were blinded to the intervention: they did not know between sharp and blunt needles was statistically significant which needle type was used in which eye at the sites of local (P = .002, with 95% CIs, 4.13-5.14 for the blunt-needle sites and anesthesia injections. The results of their evaluation are 4.99-5.96 for sharp-needle sites), which suggests that using illustrated in Figure 3B. blunt needles for local anesthesia injections in upper blepha- roplasty causes less pain than using sharp needles. Data Analysis The descriptive statistics of the study population were ana- Bruise/Hematoma lyzed by frequency for categorical variables, mean (SD) for Immediately after injection, appeared on the upper eye- normally distributed continuous variables, and median (in- lids (Figure 4A). Immediately after skin incision, accumula- terquartile range) for nonnormally distributed continuous tions of blood () were visible (Figure 4B). Figure 5 variables. Differences in pain by sharp and blunt needles shows the bruising pattern from before the injection, after the were assessed using the Wilcoxon signed rank test, while injection, and 1 year postoperatively. The occurrence of a bruise occurrence of bruise and/or hematoma was compared using and/or hematoma at the sites of injection with sharp and blunt the χ2 test. P < .05 was considered statistically significant. needles were confirmed by direct visualization of the surgi- All the analyses were performed using SPSS 19.0 (IBM Cor- cal and evaluation of photographs. These observa- poration) and GraphPad Prism 5 (GraphPad Software Inc) tions revealed that occurrence of bruise and/or hematoma in software packages. 11 (25%) eyelids treated with sharp needles vs 0 eyelids treated

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Figure 4. Photographic Documentation of Bruise and Hematoma

A After injection B After incision

Prior to the upper blepharoplasty procedure, local anesthesia was injected into the left eye with a blunt needle and the right eye with a sharp needle, and both eyelids were evaluated for bruise (A) and hematoma (B). Both bruise and hematoma were associated only with sharp-needle injection.

Figure 5. Female Patient Scheduled for Bilateral Upper Blepharoplasty

A Preoperative B After injection C One-year postoperative

A, Preoperative image. B, The left eyelid received local anesthesia injections apparent on the right eyelid (sharp needle) but not on the left (blunt needle). C, with a blunt needle, and the right eyelid with a sharp needle; bruising is One year after blepharoplasty, medial canthoplasty, and rhinoplasty.

with blunt needles. The difference observed in side-by-side a surgical wound caused by the insertion of blunt and sharp comparison between sharp and blunt needles in each patient needles (18-, 20-, 22-, and 25-gauge), directly or percutane- was statistically significant (P < .001; 95% CI, 1.12-1.58), which ously, into , intestine, spinal and/or nerve root, kid- indicates that blunt needles may reduce the incidence of bruise ney, or renal artery. Their results showed that compared with and hematoma in upper blepharoplasty compared with sharp sharp needles, blunt needles are less prone to enter vital struc- needles (Figure 3B). tures and produce hemorrhage.10 In addition, another dog study5 found that blunt needles may reduce the unintended entry into blood vessels and produce less bleeding than sharp Discussion ones. Our study of upper blepharoplasty shows a decrease in To our knowledge, this is the first prospective, side-by-side bruise and/or hematoma incidence and in level of pain by using comparison study revealing that the use of a blunt needle for blunt needles for local anesthesia injections rather than sharp local anesthesia injections in upper blepharoplasty is associ- needles. These findings are consistent with our observation ated with a lower level of pain and a lower incidence of bruise that the use of blunt needles for local anesthesia injections in and/or hematoma. This indicates that the use of blunt needles upper blepharoplasty is associated with fewer complica- can minimize patient discomfort and allow for greater surgi- tions, superior outcome, and improved recovery. Patients were cal precision when performing the upper blepharoplasty pro- satisfied with the procedure, and complications were mini- cedure and thus lead to fewer complications and faster mal. It is important to the patient to achieve a satisfying aes- recovery. thetic result without severe bruising, swelling, and disfigure- The practice of using sharp needles for local anesthesia in- ment. jections in the upper blepharoplasty procedure is wide- In this study, bruises and/or hematomas were observed in spread. However, the complications observed with this type the eyelids of 11 (25%) of 44 patients who were injected by using of needle, such as bleeding, hematoma, and bruising greatly a sharp needle in the upper blepharoplasty procedure, while favor using blunt needles for this procedure.8-10 no bruises and/or hematomas were observes in the contralat- Blunt needles have been considered easier to use and less eral eyelids of the same patients injected with a blunt needle. likely than sharp ones to produce bleeding because of inad- Moreover, the results of this study clearly show that blunt vertent penetration of arteries or adjacent vital structures. Ac- needles are less likely to enter blood vessels than sharp ones. cordingly, blunt needles are used to reduce the complications Furthermore, for the upper blepharoplasty procedure, local an- resulting from the use of sharp ones, which include bleeding, esthesia injections with blunt needles is also less likely to pro- bruising, blood vessel impalement and subsequent intravas- duce bleeding and hematoma than sharp needles. These re- cular injection and hemorrhage. sults are also consistent with results from previous studies, In a study of blunt vs sharp needle use in dogs, Heavner where fewer complications were observed from blunt needles et al10 directly observed the bleeding and penetration through than from sharp needles.8-10

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It has been noticed that in some patients undergoing a sec- ond upper blepharoplasty procedure, it was difficult to apply Conclusions local anesthesia by using the blunt needle due to the scar for- mation from the previous surgery. In fact, it may be easier to In conclusion, a comparison of blunt- vs sharp-tip needles puncture and inject the anesthesia by using a sharp needle in was the focus of this study. To our knowledge, this scar formations. study provides the first prospective side-by-side compari- son of sharp and blunt needles used for local anesthesia Limitations injections in upper blepharoplasty. The results indicate The bruise and/or hematoma was assessed by photographic that blunt needles may reduce the entry into vital structures evaluation immediately after injection and again after skin in- and reduce the occurrence of hemorrhage and hematoma. cision, but patients were not evaluated between 2 hours post- In addition, blunt needles may be more beneficial for procedure to 6 days after upper blepharoplasty; therefore, sig- performing interventional pain procedures than sharp nificant bruising of the eyelids might have missed in this period needles. Therefore, the use of blunt needles has the because of the choice of time points (after 1 hour, 1 week, and potential to become a conventional application to reduce 1, 3, and 6 months), which are in line with the regular fol- the complications during the administration of local anes- low-up time points after upper blepharoplasty used in the daily thesia injection in upper blepharoplasty and lead to a faster practice of our hospital. recovery.

ARTICLE INFORMATION Study supervision: Ma, Chen, Chang, Lin. 5. Akins EW, Hawkins IF Jr, Mladinich C, Tupler R, Accepted for Publication: July 3, 2016. Conflict of Interest Disclosures: None reported. Siragusa RJ, Pry R. The blunt needle: a new percutaneous access device. AJR Am J Roentgenol. Correction: This article was corrected on March 16, Additional Contributions: We thank the patients 1989;152(1):181-182. 2017, to fix an author’s reported affiliation. for granting permission to publish this information. 6. Frayer WC, Jacoby J. Local anesthesia. In: Duane Published Online: November 23, 2016. REFERENCES TD, Jaeger EA, eds. Clinical Opthalmology.Vol5. doi:10.1001/jamafacial.2016.1376 New York, NY: Harper and Row; 1987:1-10. Author Contributions: Drs Yu and Jin were 1. Pool SM, van Exsel DC, Melenhorst WB, Cromheecke M, van der Lei B. The effect of eyelid 7. Nelson JW. Letter to the editor. Spine. 2002;3:1- contributed equally to this work and should be 2. considered co–first authors. Drs Yu and Jin both cooling on pain, edema, erythema, and hematoma had full access to all of the data in the study and after upper blepharoplasty: a randomized, 8. Lazzeri D, Agostini T, Figus M, Nardi M, Pantaloni take responsibility for the integrity of the data and controlled, observer-blinded evaluation study. Plast M, Lazzeri S. Blindness following cosmetic the accuracy of the data analysis. Reconstr Surg. 2015;135(2):277e-281e. injections of the face. Plast Reconstr Surg. 2012;129 Study concept and design: Ma, Chen, Yang, Chang, 2. Lu JJ, Yang K, Jin XL, et al. Epicanthoplasty with (4):995-1012. Lin. double eyelidplasty incorporating modified Z-plasty 9. Soubihe Junior NV, Schmidt A, Albuquerque AA, Acquisition, analysis, or interpretation of data: Yu, for Chinese patients. J Plast Reconstr Aesthet Surg. Evora PR. Presentation of a needle for direct or Jin, Yang, Ma, Qiu, Chen, Yang, Chang. 2011;64(4):462-466. percutaneous myocardium stem cells injection. Rev Drafting of the manuscript: Yu, Chen, Chang. 3. Choi Y, Eo S. A new crease fixation technique for Bras Cir Cardiovasc. 2013;28(3):405-407. Critical revision of the manuscript for important double eyelidplasty using mini-flaps derived from 10. Heavner JE, Racz GB, Jenigiri B, Lehman T, Day intellectual content: Yu, Jin, Yang, Ma, Qiu, Yang, pretarsal levator tissues. Plast Reconstr Surg. 2010; MR. Sharp versus blunt needle: a comparative study Chang, Lin. 126(3):1048-1057. of penetration of internal structures and bleeding in Statistical analysis: Yu, Jin, Yang, Qiu, Chen, Yang, dogs. Pain Pract. 2003;3(3):226-231. Chang, Lin. 4. Fengzhi X, Wei Z, Guo-Kang F, Jiang C, Hua L. Administrative, technical, or material support: Ma, Double eyelid operation recreating the anatomic Qiu, Chen, Yang, Lin. microstructure. Ann Plast Surg. 2009;63(3):242-248.

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