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`The Official Journal of the
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`

`JOURNAL OF ENDOUROLOGY
`Volume 26, Number 2, February 2012
`ª Mary Ann Liebert, Inc.
`Pp. 174 177
`DOI: 10.1089/end.2011.0344
`
`Experimental Endourology
`
`The Impact of Local Anesthetic Volume
`and Concentration on Pain During Prostate Biopsy:
`A Prospective Randomized Trial
`
`_Ilter Tu¨ fek, M.D.,1 Haluk Akpinar, M.D.,2 Fatih Atug˘ , M.D.,2 Can O¨ bek, M.D.,3 Halil Ertu¨ rk Esen, Ph.D.,4
`Mehmet Selc¸ uk Keskin, M.D.,1 and Ali Riza Kural, M.D.5
`
`Abstract
`
`Purpose: To evaluate the effect of equivalent doses of local anesthetic administered at different concentrations
`and volumes on pain scores in patients undergoing prostate biopsy.
`Patients and Methods: This study was a single-center, randomized trial. A total of 120 patients were randomized
`into two groups with 60 patients in each group. In group 1, 2.5 mL of 2% lidocaine (low volume-high concen-
`tration) and in group 2, 5 mL of 1% lidocaine (high volume-low concentration) was injected just lateral to the
`junction between the prostate base and seminal vesicle on each side under ultrasonographic guidance. Patients
`were given an 11 point visual analog scale (VAS) to evaluate the level of pain encountered during transrectal
`ultrasonographic (TRUS) probe insertion, injection of the local anesthetic, and the biopsy procedure.
`Results: In both groups, TRUS probe insertion was the most painful stage of the procedure. With regard to local
`anesthetic injection, the VAS pain score was significantly lower in group 1 (1.56 vs. 2.41, P = 0.001). Concerning
`sampling of the prostate, group 1 had a significantly lower VAS pain score compared with group 2 (1.71 vs. 2.48,
`P = 0.008). Neither major complications nor side effects related to local anesthetic absorption occurred in both
`groups.
`Conclusion: Low volume-high concentration lidocaine administration provides superior analgesia compared
`with high volume-low concentration lidocaine during transrectal biopsy of the prostate.
`
`Introduction
`
`Transrectal ultrasonography (TRUS) guided prostate
`
`biopsy is the gold standard for the diagnosis of prostate
`cancer.1 The procedure may cause pain and discomfort; thus,
`different anesthetic techniques have been reported to enable
`the procedure to be more tolerable. Although many urologists
`prefer to use local anesthesia before prostate biopsy, the ideal
`site, type, and amount of local anesthetic are still not clear.
`Different
`local anesthetic techniques for TRUS-guided
`prostate biopsy have been described.2–5 Periprostatic nerve
`block has been reported as the most effective and commonly
`used method to diminish pain.6 The instillation of the local
`anesthetic, however, may be painful, and discomfort from
`injection may be comparable to that of obtaining core biop-
`sies.7 Decreasing local anesthesia-related pain may assist in
`diminishing pain encountered during the sampling proce-
`dure. Administration of equivalent doses of local anesthetic at
`
`high concentration and low volume may be beneficial. At-
`tempts to optimize local anesthesia technique have led to
`changes in the type and volume of anesthetic agents as well as
`the site of injection.2,3
`We report on the effect of equivalent doses of local anes-
`thetic administered at different concentrations and volumes
`on pain scores in patients who were undergoing prostate
`biopsy.
`
`Patients and Methods
`
`This study was a single-center, randomized trial. The pain
`during probe insertion, local anesthetic injection, and sam-
`pling was evaluated by visual analog scale (VAS) pain score
`(Fig. 1). After institutional research committee approval, a
`total of 120 patients were recruited for the study between
`January 2010 and July 2010. Biopsy indications were increased
`serum prostate-specific antigen (PSA)
`level and/or an
`
`1Department of Urology, Istanbul Acibadem University, School of Medicine, Istanbul, Turkey.
`2Department of Urology, Istanbul Bilim University, School of Medicine, Istanbul, Turkey.
`3Department of Urology, Istanbul University, Cerrahpasa School of Medicine, Istanbul, Turkey.
`4Department of Computational Science and Engineering, Informatics Institute, Istanbul Technical University, Istanbul, Turkey.
`5Department of Urology, Acibadem Maslak Hospital, Istanbul, Turkey.
`
`174
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`ANESTHETIC VOLUME, CONCENTRATION EFFECT ON BIOPSY PAIN
`
`175
`
`FIG. 1. Visual analog scale (VAS) pain score.
`
`abnormal digital rectal examination. Men with a history of
`biopsies, chronic prostatitis, chronic pelvic pain, inflamma-
`tory bowel disease, anorectal problems, and allergy to lido-
`caine were excluded from the study. Anticoagulation or
`antiagregant therapy was discontinued 7 days before the bi-
`opsy procedure. A written informed consent was obtained
`from all patients. Patients were randomly assigned to two
`groups, each group including 60 patients. Oral levofloxacin,
`500 mg daily, was started on the night before the biopsy and
`continued for 7 days to prevent infection. In addition, patients
`received 1 g of ceftriaxone intramuscularly 10 minutes before
`the procedure. Bowel cleansing with a self administered fleet
`enema was performed in the morning of the biopsy.
`All procedures were performed by the same surgical team
`in an outpatient setting. For local anesthesia, ultrasonographic
`examination, and biopsy, the patient was in placed in the left
`lateral decubitus position. Patients were unaware of the local
`anesthesic volume and concentration administered and were
`blindly and respectively randomized to group 1 or 2.
`A Siemens Acuson Antares Premium Edition color Doppler
`ultrasonography scanner with 9-4 MHz broad band endo-
`cavitary end firing probe with biopsy attachment was used.
`Parameters such as frequency, dynamic range, depth were
`automatically set for optimal image quality. The focus level
`was at midlevel of the prostate gland. A 22-gauge, 20 cm
`Chiba aspiration biopsy needle was used to inject the local
`anesthetic. In group 1, 2.5 mL of 2% lidocaine and in group 2,
`5 mL of 1% lidocaine was injected just lateral to the junction
`between the prostate base and seminal vesicle on each side
`using ultrasonographic guidance (Fig. 2).
`During infiltration, hitting or traversing the prostate
`capsule was avoided. In both groups, the syringe was aspi-
`rated before local anesthetic injection to avoid intravascular
`injection. After local anesthetic infiltration, the prostate was
`examined in sagittal and transverse planes. Prostate volume
`was calculated with prolate ellipsoid formula (length ·
`width · height · 0.52). Five minutes after the local anesthetic
`injection, prostate biopsy was performed in the transverse
`plane using a 12-core technique (conventional parasagittal
`sextant biopsies + 6 laterally targeted biopsies covering apex,
`midzone, and base bilaterally). Biopsy samples were ob-
`tained with 18 gauge, 25 cm Angiotech Pro-Mag biopsy
`needle (FL) using a Pro-Mag Ultra Biopty Gun (Inter V,
`Wheeling, IL).
`
`FIG. 2. Local anesthetic injection between the prostate base
`and seminal vesicle.
`
`Five minutes after the biopsy, all patients were given an 11
`point VAS to evaluate the level of pain encountered during
`TRUS probe insertion, injection of local anesthetic, and biopsy
`procedure by a blinded staff nurse.
`
`Statistical analyses
`
`The overall patient sample consisted of 120 patients. The
`sample provided a maximum error estimate of 22.2% in VAS
`pain score responses with a 99% confidence level. The error
`estimate was considered to be in acceptable limits when
`the statistically significant differences were evaluated in
`percentages.
`After conducting a Shapiro-Wilk normality assumption
`test, nonparametric Kruskal-Wallis and parametric t tests on
`both group characteristics and VAS pain score responses were
`performed to examine whether the differences between the
`two patient groups were statistically significant. Parametric
`Satterthwaite t test was used for age while comparisons of
`PSA, prostate volume, and VAS pain score responses were
`performed using nonparametric Kruskal-Wallis tests.
`
`Results
`
`Patient characteristics including age, PSA level, prostatic
`volume, and pain score responses for the two groups are
`summarized in Table 1, along with the statistical tests com-
`paring the two patient groups in terms of both patient char-
`acteristics and pain score responses. The difference between
`the two patient groups in terms of patient characteristics, such
`as age, PSA level, and prostate volume, was not statistically
`significant with the resulting P values of 0.4, 0.37, and 0.21,
`respectively.
`In both groups, TRUS probe insertion was the most painful
`part of the procedure. The difference between the patient
`groups in terms of pain score during probe insertion, how-
`ever, was not statistically significant (P = 0.77).
`Regarding local anesthetic injection, mean VAS pain score
`in group 1 (low volume-high concentration group) was lower
`than group 2 (high volume-low concentration group). The
`difference was statistically significant (P = 0.001).
`
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`176
`
`TU¨ FEK ET AL.
`
`Table 1. Descriptive and Test Statistics of Patient
`Group Characteristics and Pain Score Responses
`
`Variable (mean – SD)
`
`Group 1
`(2.5 + 2.5 mL 2%)
`n = 60
`
`Group 2
`(5 + 5 mL 1%)
`n = 60
`
`P
`
`Patient group characteristics
`61.52 – 10.52
`Age (y)
`7.83 – 8.41
`PSA (ng/mL)
`52.55 – 25.54
`Prostate
`volume (cc)
`VAS pain score responses
`2.66 – 2.61
`Probe insertion
`1.56 – 1.43
`Local anesthetic
`injection
`Sampling
`
`1.71 – 1.6
`
`62.55 – 10.34 0.4a
`9.89 – 31.99 0.37b
`49 – 27.69 0.21b
`
`2.95 – 2.95
`2.41 – 1.59
`
`0.77b
`0.001b
`
`2.48 – 1.88
`
`0.008b
`
`aSatterthwaite t test.
`bKruskal Wallis chi square test.
`SD = standard deviation; PSA = prostate specific antigen; VAS =
`visual analog scale.
`
`Concerning sampling of the prostate, mean VAS pain score
`in group 1 (low volume-high concentration group) was sig-
`nificantly lower than group 2 (high volume-low concentration
`group) (P = 0.008).
`No side effects related to local anesthetic absorption oc-
`curred in both groups. Also, there were no major complica-
`tions such as sepsis or severe rectal or urethral bleeding. One
`patient from each group was catheterized for urinary reten-
`tion after the biopsy.
`
`Discussion
`
`There are various explanations for the pain experienced
`during TRUS-guided prostate biopsy. Stretching of the anus
`that is below the dentate line occurs during probe insertion.
`Traversing the prostatic capsule, which occurs during har-
`vesting of biopsy cores, is also thought to elicit pain. The rectal
`mucosa that is perforated during the biopsy procedure is
`above the dentate line and has decreased sensorial innerva-
`tion. Therefore, most of the pain encountered during the bi-
`opsy procedure is considered to be associated with the biopsy
`needle perforating the prostate capsule.3,6 Strategies to reduce
`pain have mainly been through attenuating nociceptive
`stimuli in this latter barrier. There is inferential evidence
`supporting the latter.3,6,8
`Nash and associates9 first reported that a periprostatic
`nerve block decreased pain during TRUS biopsy in 1996.9
`Soloway and Obek10 popularized this technique in which a
`local anesthetic was injected laterally into two points on each
`side of the prostate at the apex and into the base.
`Meta-analytic studies of randomized clinical trials dem-
`onstrated that injection of a periprostatic local anesthetic was
`associated with significantly diminished pain compared with
`placebo or no injection.3,6,11,12 Periprostatic nerve block has
`been reported to be the most effective method in eliminating
`pain during TRUS-guided prostate biopsy.6 There are a
`number of factors that may influence pain control with the
`administration of local anesthetics for prostate biopsy, in-
`cluding the type of the anesthetic, the amount and concen-
`tration of the agent administered, and the site of instillation.
`Bilateral basal injection is the most common method for
`
`periprostatic nerve block.11 Some studies investigated the ef-
`ficiency of intraprostatic administration of local anesthesia
`alone or combined with periprostatic nerve block. Mutaguchi
`and colleagues13 reported that intraprostatic administration
`of local anesthesia significantly decreased the pain associated
`with prostate biopsy compared with periprostatic nerve
`block.13 Lee and coworkers14 combined intraprostatic anes-
`thesia with periprostatic nerve block and reported better re-
`sults compared with individual modalities.14 Akan and
`associates5 compared bilateral basal
`injection with single
`apical injection for periprostatic nerve block and found no
`significant difference. In fact, some investigators have re-
`ported as many as six injection sites and a total volume of as
`much as 22 mL.15 Regarding the variability of the local anes-
`thetic volume and concentration in the literature,8,11,12,15 we
`decided to focus on the volume and concentration of the local
`anesthetic using bilateral basal injections.
`This study was designed to compare the effect of equivalent
`doses but different concentration and volume of lidocaine for
`periprostatic nerve block before TRUS-guided prostate bi-
`opsy. Placebo and no intervention arms were intentionally not
`used in this study, given the strong evidence that injection of a
`local anesthetic reduces pain.3,6,11,12 In this study, pain level
`was evaluated 5 minutes after the biopsy. Performing the pain
`assessment after each step of the procedure might have pro-
`vided more reliable scores. We chose not to do it, because it is
`somewhat impractical.
`Different type, dose, and concentration of local anesthetic
`material have been reported for periprostatic nerve
`block.11,12,15 Some data suggest that infiltrating a larger vol-
`ume of local anesthetics (10 mL) is associated with lower pain
`scores compared with lower volume of local anesthetics (2.5
`5 mL).16,17 On the other hand, the use of low volume and high
`concentration local anesthetic has also been reported to sup-
`press pain and discomfort associated with prostate biop-
`sy.18,19 In a randomized study, Martella and colleagues18
`compared two different low volume-high concentration local
`anesthetics and found both to be effective to suppress pain
`and discomfort associated with prostate biopsy.18
`In a recent publication, discomfort experienced during
`transrectal biopsy of the prostate was not significantly de-
`creased with periprostatic nerve block and, interestingly, pain
`from the injection itself was similar to pain from core biop-
`sies.7 In our study, we found that pain during injection was
`lower than pain during sampling in both groups. Anxiety was
`found to be significantly related to pain scores in patients who
`transrectal prostate needle biopsy.20 Conse-
`underwent
`quently, one could assume that the pain level at the initiation
`of the procedure associated with local anesthetic injection
`may have an impact on patient anxiety, resulting in different
`pain scores during sampling. In other words, if we can per-
`form a painless local anesthetic infiltration, this may result in a
`lower state of anxiety, which may lead to a decreased per-
`ception of pain throughout the rest of the procedure. To ac-
`complish this, we planned to administer local anesthetic in
`low volume and high concentration (2.5 mL, 2%) and compare
`the effect on pain scores with equivalent local anesthetic at
`high volume and low concentration (5 mL, 1%).
`Although the same dose of local anesthetic was injected, we
`found that high concentration-low volume infiltration signifi-
`cantly reduced pain during lidocaine infiltration compared
`with low concentration-high volume application. Moreover,
`
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`ANESTHETIC VOLUME, CONCENTRATION EFFECT ON BIOPSY PAIN
`
`177
`
`patients felt significantly less pain during prostate sampling in
`the low volume-high concentration group. Bulbul and co-
`workers19 also reported their observation that patients were
`more comfortable with 2 vs. 3 mL of 2% lidocaine infiltration.
`Ashley and associates4 have reported that anesthetic in-
`jection was the most painful part of the biopsy procedure.4
`Although their injection site and local anesthetic volume and
`concentration were similar with our high volume-low con-
`centration local anesthetic group (group 2), in our study, li-
`docaine administration caused less pain than the biopsy itself
`in both cohorts.
`Diminished pain with lower volume lidocaine may at least
`be partly explained with less stretching of the nerve endings at
`the injection site. Better tolerance of pain during the actual
`prostate sampling in the lower volume and higher concen-
`tration group may be explained with a lower level of anxiety
`after a less painful infiltration and consequently less pain
`during the biopsy.
`Thus, we demonstrated that high concentration-low vol-
`ume local anesthetic injection with lower pain scores enables a
`more comfortable prostate sampling.
`
`Disclosure Statement
`
`No competing financial interests exist.
`
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`
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`20. Tekdogan U, Tuncel A, Nalcacioglu V, et al. Is the pain level
`of patients affected by anxiety during transrectal prostate
`needle biopsy? Scand J Urol Nephrol 2008;42:24 28.
`
`Address correspondence to:
`_Ilter Tu¨ fek, M.D.
`Buyukdere Cad 40
`Maslak
`34457 Istanbul
`Turkey
`
`E-mail: iltertuf@gmail.com
`
`Abbreviations Used
`PSA prostate specific antigen
`TRUS
`transrectal ultrasonography
`VAS visual analog scale
`
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