7/27/2019 76444824

1/5

Original article doi:10.1111/j.1463-1318.2011.02812.x

No effect of perianal application of topical anaesthetic onpatient comfort during nonsedated flexible 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 flexible

sigmoidoscopy. We therefore aimed to evaluate this in a

randomized manner.

MethodOne hundred and forty-six patients who under-

went flexible 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 mon-

itoring during procedures were recorded. Pain was

assessed by visual analogue scale (VAS) and anxiety levels

by the State-Trait Anxiety Inventory (STAI-I andSTA-II).

ResultsMedian 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 significantly lower than pre-procedural values

in each group (P < 0.001). There was no significant

difference in VAS scores among the groups. In all groupsthere 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 influence patient comfort during sigmoidoscopy.

KeywordsSigmoidoscopy, local anesthesia, patient com-

fort

What is new in this paper?

Using a local anaesthetic lubricating jelly during lowergastrointestinal endoscopy is accepted practice to reduce

pain and improve manoeuverability. However, our studyfound that use of anaesthetic gel before flexible sig-moidoscopy is of no significant benefit.

Introduction

As sigmoidoscopy is usually performed without sedation,

patients frequently feel discomfort during the procedure.

This is related to the examination itself modified by the

experience of the endoscopist, over-insufflation or loop

formation with stretching and to the anatomical proper-ties 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 applica-

tion of perianal topical anaesthetics. There are, however,

no data on their impact on patient comfort during

nonsedated flexible sigmoidoscopy. The aim of this

randomized study was to investigate the effect on patient

comfort of different topical anaesthetics applied to theanus before nonsedated sigmoidoscopy.

Method

Patients

The study was approved by the Ethics Committee of the

General Directorate of Pharmaceuticals and Pharmacy.

After written informed consent the patients were recruited

Correspondence to: Mehmet A Kuzu MD, FACS, Department of Surgery, Faculty

of Medicine, Ankara University, 06100 Samanpazar, Ankara, Turkey.

E-mail: ayhankuzu@yahoo.com

2011 The Authors

872 Colorectal Disease 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 872875

7/27/2019 76444824

2/5

prospectively from those referred for flexible sigmoidos-

copy 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

fitting 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

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 con-

sists of two sections each having 20 questions. The first

section (STAI-I) evaluates the state of anxiety by ques-

tions 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 understressful 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

Assuming a one-way design with three groups with a

sample size of 45 each, the total sample of 135 subjects

achieves a power of 0.80 using the KruskalWallis test

with a target significance 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 ordi-

nal 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, follow-

ing 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 findings. 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 significantly lower than pre-procedural values in

each group (P< 0.001). There was no significant differ-

ence for VAS scores among groups. The evaluation

within groups revealed statistically higher VAS scoresduring the procedure when compared with pre- and post-

procedural scores (P< 0.001) (Table 1). State and trait

anxiety and procedure-related pain were not affected by

age and gender.

Discussion

It is known that patients may experience pain and dis-

comfort during colonoscopy and flexible sigmoidoscopy.

C. Cengiz et al. Patient comfort during sigmoidoscopy

2011 The Authors

Colorectal Disease 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 872875 873

7/27/2019 76444824

3/5

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 difficulty for the endoscopist and moreincomplete procedures [5,8].

Lower body mass index, younger age, intubation time,

preparation status, previous hysterectomy and antispas-

modic agent use were identified 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 discom-

fort 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 significantly improve patient comfort, ease of inser-

tion, 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 extra-

flexible 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 insufflation [18].

Whether perianal application of topical anaesthetic

reduces patient anxiety, pain and discomfort duringlower 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 significantly lower after the procedure when com-

pared with pre-procedural values, which revealed that

patients anxiety diminished when the procedure was over.

However, the fact that VAS scores significantly increased

during the procedure, and that STAI-I and VAS scores

were similar in all groups before and after flexible

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 epi-

sodes 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 flexible sigmoidoscopy. There-

fore, their use in this examination is of no benefit.

References

1 Jechart G, Messmann H. Indications and techniques for

lower intestinal endoscopy.Best Pract Res Clin Gastroenterol

2008; 22:77788.

2 Conover WJ. (1980) Several independent samples. In:

Practical Nonparametric Statistics, 2nd edn (ed. Conover

WJ), pp. 22939. Wiley&Sons, New York.

3 Siegel S, Castellan NJJ. (1988) The friedman two-way

analysis of variance by ranks. In: Nonparametric Statistics

for the Behavioral Sciences, 1st edn (eds Siegel S, Castellan

NJJ), pp. 17483. McGraw-Hill Inc, New York.

4 Hintze J. (2008) PASS 2008. NCSS, LLC, Kaysville, Utah.

http://www.ncss.com

5 Johnson JE, Morrissey JF, Leventhal H. Psycological prep-

aration for an endoscopic examination. Gastrointest Endosc

1973; 19:1801.

6 Brandt L. Patients attitudes and apprehensions about

endoscopy: how to calm troubled waters. Am J Gastroenterol

2001; 96:2804.

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)

Group 2 Lidocaine

(n= 51)

Group 3 Lidocaine + Prilocaine

(n= 46)

Pre In Post Pre In Post Pre In Post

STAI-I 45 (2067) 35 (2065)** 46 (2069) 34 (2063)** 40.5 (2066) 33.5 (2050)**

STAI-II 42 (2455) 38 (2859) 40 (2857)

VAS 0 (04)* 2 (04) 0 (03)* 0 (04) 2 (04) 0 (03) 0 (03)* 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.

Patient comfort during sigmoidoscopy C. Cengiz et al.

2011 The Authors

874 Colorectal Disease 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 872875

7/27/2019 76444824

4/5

7 Bejes C, Marvel MK. Attempting the improbable: offering

colorectal cancer screening to all appropriated patients. Fam

Pract Res J1992; 12:8390.

8 Petravage J, Swedberg J. Patient response to sigmoidoscopy

recommendations via mailed reminders. J Fam Pract1988;

27:3879.

9 Takahashi Y, Tanaka H, Kinjo M, Sakumoto K. Prospectiveevaluation of factors predicting difficulty and pain during

sedation-free colonoscopy. Dis Colon Rectum 2005; 48:

1295300.

10 Elphick DA, Donnelly MT, Smith KS, Riley SA. Factors

associated with abdominal discomfort during colonoscopy: a

prospective analysis. Eur J Gastroenterol Hepatol2009; 21:

107682.

11 Dumot JA, Verzola E, Nicol S, Easley KA, Vargo JJ, van Stolk

RU. Sublingual hyoscyamine for patient comfort during screen-

ing sigmoidoscopy: a randomized, double-blind, placebo-

controlled clinical trial.Gastrointest Endosc1998; 48: 2836.

12 Han Y, Uno Y, Munakata A. Does flexible small-diameter

colonoscope reduce insertion pain during colonoscopy?

World J Gastroenterol2000; 6: 65963.13 Sedlack RE, Kolars JC, Alexander JA. Computer simulation

training enhances patient comfort during endoscopy. Clin

Gastroenterol Hepatol2004; 2:34852.

14 Ovayolu N, Ucan O, Pehlivan S, Buyukhatipoglu H, Savas

MC, Gulsen MT. Listening to Turkish classical music

decreases patients anxiety, pain, dissatisfaction and the dose

of sedative and analgesic drugs during colonoscopy: a

prospective randomized controlled trial. World J Gastroen-

terol2006; 12: 75326.

15 Lopez-Cepero Andrada JM, Amaya Vidal A, Castro Aguilar-Tablada T et al. Anxiety during the performance of

colonoscopies: modification using music therapy. Eur J

Gastroenterol Hepatol2004; 16:13816.

16 El-Hassan H, McKeown K, Muller AF. Clinical trial: music

reduces anxiety levels in patients attending for endoscopy.

Aliment Pharmacol Ther2009; 30:71824.

17 Jess P, Bulut O, Almasi A, Waaddegaard P. The usefulness of

magnetic endoscope locating device in colonoscopy in daily

practise: a prospective cas-controlled study. Surg Endosc

2009; 23:13535.

18 Church J, Delaney C. Randomized controlled trial of

carbondioxide insufflation during colonoscopy. Dis Colon

Rectum2003; 46: 3226.

19 Shah SG, Brooker JC, Thapar C, Williams CB, SaundersBP. Patient pain during colonoscopy: an analysis using

real-time magnetic endoscope imaging. Endoscopy 2002;

34: 43540.

C. Cengiz et al. Patient comfort during sigmoidoscopy

2011 The Authors

Colorectal Disease 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 872875 875

7/27/2019 76444824

5/5

Copyright of Colorectal Disease is the property of Wiley-Blackwell and its content may not be copied or

emailed to multiple sites or posted to a listserv without the copyright holder's express written permission.

However, users may print, download, or email articles for individual use.