Original article

doi:10.1111/j.1463-1318.2011.02812.x

No effect of perianal application of topical anaesthetic on patient comfort during nonsedated exible sigmoidoscopy: a randomized, placebo-controlled clinical trial
C. Cengiz*, H. K. Pampal, B. Ozdemir*, S. Boyacioglu* and M. A. Kuzu
*Department of Gastroenterology, Mesa Hospital, Ankara, Turkey, Department of Anesthesiology and Intensive Care, Mesa Hospital, Ankara, Turkey and Department of Surgery, Faculty of Medicine, Ankara University, Ankara, Turkey Received 23 April 2011; accepted 2 August 2011; Accepted Article online 7 September 2011

Abstract
Aim A literature review revealed no data on the effects of topical anaesthetic on patient comfort during exible sigmoidoscopy. We therefore aimed to evaluate this in a randomized manner. Method One hundred and forty-six patients who underwent exible sigmoidoscopy were randomly allocated to one of three groups. Vaseline (n = 49), 2% lidocaine gel (n = 51) or a cream of 2.5% lidocaine plus 2.5% prilocaine (n = 46) were applied to the patients 30 min before the procedure. Demographic data and haemodynamic monitoring during procedures were recorded. Pain was assessed by visual analogue scale (VAS) and anxiety levels by the State-Trait Anxiety Inventory (STAI-I and STA-II). Results Median pre-procedural STAI-I scores were 45, 46 and 40.5 and median post-procedural STAI-I scores were 35, 34 and 33.5 for the vaseline, lidocaine, and lidocaine prilocaine treatments, respectively. There was no statistical difference among the groups in terms of STAI-I and II scores. However, post-procedural STAI-I scores were signicantly lower than pre-procedural values in each group (P < 0.001). There was no signicant difference in VAS scores among the groups. In all groups there were statistically higher VAS scores during the procedure compared with the pre- and post-procedural scores (P < 0.001). Conclusion Perianal application of topical anaesthetic does not inuence patient comfort during sigmoidoscopy. Keywords Sigmoidoscopy, local anesthesia, patient comfort What is new in this paper? Using a local anaesthetic lubricating jelly during lower gastrointestinal endoscopy is accepted practice to reduce pain and improve manoeuverability. However, our study found that use of anaesthetic gel before exible sigmoidoscopy is of no signicant benet.

Introduction
As sigmoidoscopy is usually performed without sedation, patients frequently feel discomfort during the procedure. This is related to the examination itself modied by the experience of the endoscopist, over-insufation or loop formation with stretching and to the anatomical properties of the sigmoid colon such as redundancy or mobility [1]. The in and out movements of the endoscope may cause anal discomfort, perhaps with some anal sphincter spasm, which may hamper manipulation of the endoscope and worsen patient discomfort during the procedure.

Various methods have been tested to improve patient comfort during lower endoscopy, including the application of perianal topical anaesthetics. There are, however, no data on their impact on patient comfort during nonsedated exible sigmoidoscopy. The aim of this randomized study was to investigate the effect on patient comfort of different topical anaesthetics applied to the anus before nonsedated sigmoidoscopy.

Method
Patients

Correspondence to: Mehmet A Kuzu MD, FACS, Department of Surgery, Faculty of Medicine, Ankara University, 06100 Samanpazar, Ankara, Turkey. E-mail: ayhankuzu@yahoo.com

The study was approved by the Ethics Committee of the General Directorate of Pharmaceuticals and Pharmacy. After written informed consent the patients were recruited

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prospectively from those referred for exible sigmoidoscopy at the Mesa Hospital Colorectal Clinic (Ankara, Turkey) between November 2008 and February 2010. Inclusion criteria were age > 18 years and ASA status of I and II. Exclusion criteria were use of anti-anxiety medicine within 48 h before the procedure, cognitive dysfunction, past history of having lower endoscopy or anal colorectal or gynaecological surgery and pain at the anal area precluding examination. There were 175 eligible patients. Block randomization was used to keep the sample size of the groups similar and each block was set to 3. RANDOM ALLOCATION SOFTWARE (Ver. 1.0.0; developed by M. Saghaei, MD., Department of Anaesthesia, Isfahan University of Medical Sciences, Isfahan, Iran; http:// mahmoodsaghaei.tripod.com/Softwares/randalloc.html) was used to allocate the patients into groups. Patients tting the above criteria were randomized to three groups according to the perianal application of different topical agents 30 min before the procedure as follows: group 1, vaseline application (placebo); group 2, 2% lidocaine gel (Cathejell gel; Montavit, Tyrol, Austria) and group 3, 2.5% lidocaine plus 2.5% prilocaine cream (Emla %5; Astra Zeneca, London, UK). A single endoscopy nurse (BO) applied the topical anaesthetics and placebo. All the procedures were performed by three endoscopists (CC, MAK and SB) who were blinded to the agent applied. Demographic data and haemodynamic monitoring (i.e.: heart rate, blood pressure and oxygen saturation) during procedures were recorded by the anaesthetist (HKP) who was also blinded to the type of topical agent. The same anaesthetist also assessed the results.
Pain and anxiety evaluation

achieves a power of 0.80 using the KruskalWallis test with a target signicance level of 0.050 and an actual difference level of 0.044. Nominal variables were evaluated by the v2 test. Differences among the three groups for nonparametric continuous variables or ordinal variables were evaluated by the KruskalWallis variance analysis followed by a multiple comparisons test [2]. Within-group comparisons of ordinal variables were assessed by the Friedman two-way ANOVA or Wilcoxon signed ranks test, where appropriate, following a multiple comparison test [3]. Statistical analyses were performed using SPSS for Windows Version 11.5 (SPSS Inc., Chicago, Illinois, USA) and PASS 2008 [4].

Results
Sixteen of the 175 eligible patients were excluded before the study (previous endoscopy or surgery [8 patients], anxyolitic drug use [3 patients] and pain [5 patients]). The remaining 159 were randomized into the three treatment groups. Thirteen of the 159 patients were excluded during the study. Haemorrhoidal band ligation was the reason for exclusion of two patients in group 1, one patient in group 2, and three patients in group 3. Also, two patients in group 1, one patient in group 2 and four patients in group 3 were excluded owing to a previously performed colonoscopy. This left a sample size of 146, including 49 patients in group 1, 51 in group 2, and 46 in group 3. Patient ages were 33 (2376), 32 (1856) and 35.5 (1748) years in groups 1, 2 and 3, respectively. The male to female ratios were 23:26, 23:28 and 22:24. The groups were similar with respect to demographic and haemodynamic ndings. No adverse drug reactions or major cardiovascular or pulmonary complications were observed during the study. There was no statistical difference among the groups according to STAI-I (both pre- and post-procedural) and STAI-II scores. However, post-procedural STAI-I scores were signicantly lower than pre-procedural values in each group (P < 0.001). There was no signicant difference for VAS scores among groups. The evaluation within groups revealed statistically higher VAS scores during the procedure when compared with pre- and postprocedural scores (P < 0.001) (Table 1). State and trait anxiety and procedure-related pain were not affected by age and gender.

Patients were asked to rate the intensity of pain using a visual analogue scale (VAS) ranging from 0 to 10 before, during and after the procedure. They also completed the State-Trait Anxiety Inventory (STAI) form, which consists of two sections each having 20 questions. The rst section (STAI-I) evaluates the state of anxiety by questions about the individuals transitory emotional status and feelings at the moment, and the second section (STAI-II) refers to trait anxiety, showing how the tendency of an individual to become anxious under stressful conditions. STAI-I was determined both before and after the procedure and STAI-II was determined only before the procedure, because it is a measure of the more general and long-standing quality of trait anxiety.
Statistical analysis

Discussion
It is known that patients may experience pain and discomfort during colonoscopy and exible sigmoidoscopy.

Assuming a one-way design with three groups with a sample size of 45 each, the total sample of 135 subjects

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Table 1 State-Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) scores for patients given perianal topical anaesthetics before (Pre), during (In) and after (Post) sigmoidoscopy. Group 1 Vaseline (n = 49) Pre STAI-I STAI-II VAS 45 (2067) 42 (2455) 0 (04)* In Post 35 (2065)** 2 (04) 0 (03)* Group 2 Lidocaine (n = 51) Pre 46 (2069) 38 (2859) 0 (04) In Post 34 (2063)** 2 (04) 0 (03) Group 3 Lidocaine + Prilocaine (n = 46) Pre 40.5 (2066) 40 (2857) 0 (03)* In Post 33.5 (2050)** 2 (05) 0 (03)*

Values are expressed as median (minimummaximum). **P < 0.001 compared with pre-STAI-I within groups. *P < 0.001 compared with In-VAS within groups.

Because of this, many people feel anxious, thus lowering their willingness to undergo these procedures even when they are necessary [57]. This is one reason why this procedure has been under-used in the general population. Increased anxiety levels may lead to more discomfort for patients, more difculty for the endoscopist and more incomplete procedures [5,8]. Lower body mass index, younger age, intubation time, preparation status, previous hysterectomy and antispasmodic agent use were identied as the predictors of patient pain during nonsedated colonoscopy [9]. Also, a recent study reported that female sex, a diagnosis of irritable bowel syndrome, high anxiety and anticipation of discomfort are the factors associated with discomfort during colonoscopy [10]. Thus, conscious or deep sedation has been implemented to overcome procedural discomfort; however, this has its own risks and disadvantages. Various methods have been tested to reduce patient discomfort without giving sedation. Giving sublingual hyoscyamine tablets before screening sigmoidoscopy did not signicantly improve patient comfort, ease of insertion, or the depth of sigmoidoscope insertion during the procedure [11]. Methods that have proven successful in reducing pain include the use of a small-diameter extraexible colonoscope [12], physician training with use of a computer-based endoscopy simulator [13], listening to music during the procedure [1416], use of magnetic endoscope imaging to avoid loop formation and colon stretching [17], and carbon dioxide insufation [18]. Whether perianal application of topical anaesthetic reduces patient anxiety, pain and discomfort during lower endoscopy has never been studied, even though these agents are commonly used. Sedation is not routinely used during sigmoidoscopy in our centre. After eliminating the factors that may affect patient pain and anxiety levels during the procedure, we had comparable study and control groups with similar demographics and trait anxiety. Predictably, STA-I scores were signicantly lower after the procedure when compared with pre-procedural values, which revealed that

patients anxiety diminished when the procedure was over. However, the fact that VAS scores signicantly increased during the procedure, and that STAI-I and VAS scores were similar in all groups before and after exible sigmoidoscopy, indicates that perianal application of topical anaesthetics (lidocaine or lidocaine plus prilocaine) does not reduce the patients state of anxiety and pain. This suggests that anal sphincter spasm, which should be reduced by topical anaesthetics, does not have a major role in patient discomfort during sigmoidoscopy. Pain episodes during colonoscopy have been correlated with the point of the examination at which the colonoscope tip is in the sigmoid colon, suggesting that looping of the endoscope in the variable anatomy of the sigmoid colon is the main reason for pain [19]. This can be reduced by using magnetic endoscope imaging techniques. In conclusion, the present study shows that perianal application of topical anaesthetic agents does not improve patient discomfort during exible sigmoidoscopy. Therefore, their use in this examination is of no benet.

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