A study of the pain score
following TRUS guided prostate biopsy with and without periprostatic
lignocaine infiltration
Ali Q.1, Grower J.2
1Dr Qutubuddin Ali, 2Dr Jitendra Grower, both are Assistant Professor,
Department of Surgery, L.N. Medical College, Bhopal, MP, India
Address for
Correspondence: Dr Qutubuddin Ali, Email:
aliqutub74@icloud.com
Abstract
Introduction:
Prostate cancer is one of the most common cancers in Western countries
and is now increasing worldwide. Transrectal ultrasound guided prostate
needle biopsy (TRUS) is the standard procedure to diagnose or exclude
prostate cancer. TRUS-guided biopsy is associated with several
complications and discomfort. We evaluated painless yet less invasive
prostate biopsy. Material
and Methods: A randomised xwas conducted in 30
consecutive men divided into two groups. Group I consisted of fifteen
patients who did not receive any analgesia, and another fifteen
constituted study group, Group II, who received periprostatic
infiltration of 1 % lignocaine. Patient with suspected DRE findings or
elevated PSA or both were advised to undergo TRUS guided prostate
biopsy. Pain intensity during the procedure was evaluated using Visual
Analogue Scale. A visual analog scale was used to assess the pain
score. Statistical analysis of pain scores was performed using the
Student t test. Chi-square/ Fisher Exact test was used to find the
significance of study parameters on categorical scale between two. Results: In Group 2,
there was a marked reduction in the pain experienced during the
procedure. The Chi-squared test for trend showed a significant
association between the periprostatic infiltration of 1 % lignocaine
and reduction in pain on probe insertion and on taking the biopsy (P =
0.0001). Conclusion:
The use of periprostatic infiltration of lignocaine before taking the
needle biopsy significantly reduces the pain experienced by the patient
during TRUS-guided prostate biopsy.
Keywords:
Prostate, Transrectal ultrasound, Biopsy, Periprostatic infiltration
Manuscript received:
10th April 2017, Reviewed:
18th April 2017
Author Corrected:
24th April 2017, Accepted
for Publication: 30th April 2017
Introduction
Prostate cancer (PCa) is one of the most common cancers in men, with
about 700,000 patients diagnosed worldwide each year [1]. Transrectal
Ultrasound (TRUS) guided prostate biopsy is regarded as the gold
standard for prostate cancer diagnosis as demonstrated by recent
studies. The majority of patients perceive TRUS-guided prostate biopsy
as a physically and psychologically traumatic experience [2].
The International Association for the Study of Pain has offered the
following definition of pain: “Pain is an unpleasant sensory
and emotional experience associated with actual or potential tissue
damage, or described in terms of such damage” [3]. Two
factors are usually responsible for pain during transrectal prostate
biopsy: anal pain due to ultrasound probe, that causes pressure and
stretching of muscle fibers, and pain at insertion of the needle
through the prostate [3]. All of the pain-rating scales are reliable
and valid. The well-known visual analogue scale (VAS) and numeric
rating scale (NRS) for assessment of pain intensity agree well and are
equally sensitive in assessing acute pain after surgery , and they are
both superior to a fourpoint verbal categorical rating scale (VRS). The
most commonly used anesthetic is lidocaine either in gel suspension or
as an injectable preparation (periprostatic nerve block - PPNB) [4]
although there is no strong evidence to recommend the different types
of anesthetics that may be used. Some authors doesn’t use any
types of anesthetics during transrectal prostate biopsy.
Men undergoing PBx experience considerable psychological stress,
attributable to the fear of a potential cancer diagnosis, the anal
route of penetration, that the subject organ is part of the sexual
system, and the anticipated pain [5]. Therefore, many urologists have
stressed the importance of anaesthesia as an integral part of PBx
[6–8]. However, despite these considerations, using
anaesthesia is still under debate because of doubt of its real benefits
and the associated costs [9].
The present study was designed to compare the pain score following TRUS
guided prostate biopsy with and without periprostatic lignocaine
infiltration and future recommendation thereof.
Material
and Methods
The present study was a randomised control study carried out in
department of Surgery, L N Medical College and Hospital, Bhopal. A
total of 30 consecutive men undergoing transrectal prostate biopsy in
our department were enrolled for the study after having met the
inclusion criteria and obtaining written informed consent. They were
randomly divided into two groups - Group I consisted of fifteen
patients who did not receive any analgesia, and another fifteen
constituted study group, Group II, who received periprostatic
infiltration of 1 % lignocaine.
Study design- Randomised
control study.
Inclusion criteria-
Patients who needed transrectal biopsy for suspected carcinoma of
prostate either by digital rectal examination or elevated serum PSA
level.
Exclusion criteria- Bleeding
disorder, Acute prostatitis, Anal stenosis , Painful anal or perianal
conditions
Collection of data- Male
patients attending our outpatient department with history of lower
urinary tract symptoms were evaluated and obtained written consent. A
detailed clinical examination including digital rectal examination
(DRE) was performed. Patient with suspected DRE findings or elevated
PSA or both were advised to undergo TRUS guided prostate biopsy.
Before the procedure, routine hematological and biochemical
investigations like hemoglobin, total differential leukocyte count,
coagulogram, blood urea, serum creatinine, random blood sugar and urine
culture and sensitivity were performed.
Methodology- Patients
were examined in left lateral decubitus position. Digital rectal
examination was performed before inserting the TRUS probe. In group l
(n=15) intrarectal KY jelly was applied, which has no analgesic action.
In group II (n= 15), periprostatic infiltration of 1% lignocaine was
performed. After transrectal placement of the probe, the prostate was
imaged in the transverse and sagittal planes. With the prostate viewed
in sagittal plane, an 8-inch 22 gauge Chiba needle was introduced under
ultrasound guidance into the region of the bladder neck, at the base of
prostate, just lateral to the junction between the prostate and seminal
vesicle. Approximately 2.5ml of 1% lignocaine was injected at each site
on each side of the prostate. The syringe was aspirated before
injection to ensure that the vascular system has not been entered.
After injection, biopsy of the prostate was done with an 18-gauge
biopsy needle fired by a spring action biopsy gun. Right after the
procedure patient were asked to score pain caused by needle insertion
into the prostate on a 10 point visual analogue scale (VAS), 0 being no
pain and 10 being most severe pain ever experienced.
Statistical analysis-
Descriptive statistical analysis was carried out in the present study.
Student t test (two tailed, independent) was used to find the
significance of study parameters on continuous scale between two groups
Inter group analysis) on metric parameters, Chi-square/ Fisher Exact
test was used to find the significance of study parameters on
categorical scale between two. P value less than 0.05 was considered
significant.
Statistical software-
The statistical software SPSS 10.0 was used for the analysis of the
data and Microsoft word and excel have been used to generate graphs,
tables etc.
Results
In this prospective study a total of 30 patients, who presented with
complaints of LUTS and with either elevated serum PSA or abnormal
digital rectal examination were enrolled and subjected for prostate
biopsy.
The patients were divided into two groups. Group 1 received intrarectal
K Y jelly & Group 2 received peri-prostatic infiltration of 1%
lignocaine before the procedure. The comparative data of the two groups
of patients is shown in table 1.
Table-1: Comparative data
of the two groups of patients
|
Variables
|
Group
I
( n
= 15)
|
Group
II
(n
= 15)
|
P
value
|
|
Age in years
|
68.20±8.21
|
67.20±8.77
|
0.750
|
|
Prostate Volume in cc
|
42.70±16.76
|
46.67±12.22
|
0.469
|
|
Serum PSA in ng/ml
|
43.68±62.53
|
70.28±84.29
|
0.247
|
|
VAS score
|
5.53±2.75
|
2.53±1.55
|
0.001
|
|
Immediate complications
|
66.7 %
|
26.7 %
|
0.117
|
|
Delayed complications
|
13.3 %
|
6.7 %
|
0.483
|
Age distribution-
The mean age of the patients in group 1 was 68.2 years
±8.21, with a range of 51- 85. In group 2 range of age was
50 - 82 with mean age of 67.2 years ±8.77. Both groups were
comparable for their age (p=0.750). (Table-2, Fig 1).
Table-2: Age distribution
of patients
|
Age in
years
|
Group I
|
Group II
|
Total
|
|
No
|
%
|
No
|
%
|
No
|
%
|
|
50-59
|
2
|
13.3
|
4
|
26.7
|
6
|
20.0
|
|
60-69
|
5
|
33.3
|
4
|
26.7
|
9
|
30.0
|
|
70-79
|
7
|
46.7
|
6
|
40.0
|
13
|
43.3
|
|
80& above
|
1
|
6.7
|
1
|
6.7
|
2
|
6.7
|
|
Total
|
15
|
100.0
|
15
|
100.0
|
30
|
100.0
|
Pain score- The
mean pain score in group I was 5.53 ± 2.75 whereas in group
II mean value was 2.53 ± 1.55. Mean pain score was
significantly less in group II when compared to group I (p=.001). In
study group 73.3 % patient had mild pain during the biopsy whereas only
26.7% patients had mild pain, which was statistically significant.
Similarly one third of patients in control group had severe pain as
compared to only 16.7 % patients in study group who recorded severe
pain. (Table-3).
Table-3: Comparison of
pain score in two groups of patients
|
Pain score
|
Group I
|
Group II
|
Total
|
|
No
|
%
|
No
|
%
|
No
|
%
|
|
None(0)
|
0
|
0.0
|
0
|
0.0
|
0
|
0.0
|
|
Mild(1,2,3)
|
4
|
26.7
|
11
|
73.3
|
15
|
50.0
|
|
Moderate (4,5,6)
|
6
|
40.0
|
4
|
26.7
|
10
|
33.3
|
|
Severe (7,8,9,10)
|
5
|
33.3
|
0
|
0.0
|
5
|
16.7
|
|
Total
|
15
|
100.0
|
15
|
100.0
|
30
|
100.0
|
|
Mean ± SD
|
5.53±2.75
|
2.53±1.55
|
4.03±2.67
|
Discussion
The prevalence of asymptomatic prostate cancer in the population
increases with age. As much as 64% of men between the age of 60-70
years harbor cancerous cells in the prostate [10]. Like all cancers,
prostate cancer is best managed when diagnosed early as both the
recurrence-free survival and the cancer-specific survival are inversely
related to the stage of disease at detection [11].
Many studies done so far are supporting the role of local anesthesia in
reducing pain and complications following transrectal ultrasound guided
prostate biopsy. This study is a prospective study done to establish
the role of peri-prostatic infiltration of 1% lignocaine in reducing
pain during the procedure & reducing incidence of morbities and
complications associated with TRUS guided biopsy. Our study support the
hypothesis that peri-prostatic infiltration of 1% lignocaine reduces
the pain. Bulbul et al [12] in their study on 72 patients,
respectively, evaluated the effect of periprostatic local anesthetic
injection on pain relief during prostate biopsy. Saad et al [13]
observed that the rectal administration of lignocaine gel reduces the
pain experienced during the biopsy. Desgrandchamps et al [14] disagree
and state that the rectal administration of lignocaine gel has no
benefit over placebo.
Wang J et al [15] and Woo et al [16] concluded that combined modalities
show better analgesic efficacy than periprostatic nerve block alone for
transrectal ultrasound-guided prostate biopsy without increased
morbidities. Among the various local analgesics, lidocaine-prilocaine
cream seems to offer the best overall efficacy.
Similarly Hiros M et al [17] studied in 90 patients who fulfilled the
inclusion criteria were randomized into 3 groups of 30 patients each.
Group 1 received periprostatic local anesthesia with 2% lidocaine,
group 2 received Voltaren supp placed in rectum an hour before biopsy
while group 3 received no local anesthesia. Pain scale responses were
analyzed for each aspect of the biopsy procedure with a visual analog
scale of 0-none to 10-maximal. There was no difference between the 3
groups in pain scores during digital rectal examination, intrarectal
injection and probe insertion. The mean pain scores during needle
insertion in group 1 receiving periprostatic nerve block and in group 2
receiving Voltaren supp were 3,10 +/- 2,32 and 5,15 +/- 2,01
respectively. In group 3 (no local anesthesia), mean pain scores were
6,06 +/- 2,95 which was found to be significantly different (p <
0,001). However, morbidity after the biopsy was not statistically
different between all 3 groups. TRUS-guided prostate biopsy is a
traumatic and painful experience, but the periprostatic blockage use is
clearly associated with more tolerance and patient comfort during the
exam. It is an easy, safe, acceptable and reproducible technique and
should be considered for all patients undergoing TRUS biopsy regardless
of age or number of biopsies.
Peyromaure et al [18] found that only 47.6% of 275 patients described
the procedure as painful (mild in two-thirds) on a visual analog scale
(VAS), given adequate information before the procedure. By
prospectively comparing a 12 with a 6 core biopsy protocol Naughton et
al[19] noted no statistically significant difference in the 2
procedures in regard to any mean pain level at biopsy or subsequently.
Zisman at al [20] evaluated the impact of prostate biopsy on patient
well-being in 211 consecutive men in whom a mean of 8 biopsy cores was
obtained. Immediate pain or discomfort was experienced during the
procedure by 96% and 89% of their patients, respectively.
Another issue is the concept of pain accumulation, as introduced by
Saha PK et al [21] They found that pain during biopsy gradually
accumulates from the first core to the last one even when anesthesia is
administered. Their study remains the only report to address the pain
score at biopsy after each single sample.
Therefore it is concluded that peri-prostatic infiltration of 1 %
lignocaine provides pain relief during the TRUS guided prostate biopsy
and thereby may decrease the early complications of the procedure.
Conclusion
Many patients have pain during transrectal ultrasound guided biopsies
of the prostate and few clinicians provide a periprostatic nerve block
before this procedure. A periprostatic nerve block administered before
the biopsies dramatically decreases discomfort. We urge all urologists
to attempt this procedure, and we are confident that they will adopt it
as part of their practice.
The main limitation of the current study being small sample size. This
is very simple technique and the skill can be acquired easily. We
recommend nerve block during every TRUS guided prostate biopsy. However
a future studies with a large number of patients should be carried out
before adopting this recommendation.
Funding:
Nil, Conflict of
interest: None initiated.
Permission from IRB:
Yes
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How to cite this article?
Ali Q, Grower J. A study of the pain score following TRUS guided
prostate biopsy with and without periprostatic lignocaine infiltration.
Int J Med Res Rev 2017;5(04):393-398 doi:10.17511/ijmrr. 2017.i04.04.