|Year : 2020 | Volume
| Issue : 9 | Page : 1183-1187
Apical peri-prostatic nerve block versus intra-rectal xylocaine gel for trans- rectal ultrasound guided prostate biopsy among Nigerian patients: A prospective randomized study
EV Ezenwa1, SO Osaghae2, EO Ozah1, G Okparanta3
1 Department of Surgery, Urology Unit, University of Benin Teaching Hospital, Benin City, Edo State, Nigeria
2 Department of Surgery, Urology Unit, University of Benin Teaching Hospital; Department of Surgery, College of Medicine, University of Benin, Benin City, Edo State, Nigeria
3 Department of Surgery, College of Medicine, University of Benin, Benin City, Edo State, Nigeria
|Date of Submission||20-Apr-2020|
|Date of Acceptance||01-Jun-2020|
|Date of Web Publication||10-Sep-2020|
Dr. E V Ezenwa
Department of Surgery, Urology Unit, University of Benin Teaching Hospital, Benin City, Edo State
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Aims: This study compared the analgesic effect of apical peri-prostatic block with that of intra-rectal xylocaine gel for trans-rectal ultrasound guided prostate biopsy (TRUS-PBx) in Nigeria. Methods: This is a prospective randomized comparative study carried out over one year in University of Benin Teaching Hospital, Edo State, Nigeria. The participants were randomized into two groups; Group A had 10 mls of intra-rectal xylocaine gel instillation while Group B had apical infiltration of 10 mls of 1% xylocaine all before TRUS-PBx. Result: There was a statistically significant difference in the mean pain score during and one hour after TRUS-PBx between Group A and Group B of the study population respectively (p < 0.0001). Those that had intra-rectal xylocaine gel (Group A) had more pain during and after biopsy. There was no difference in the mean pain score during probe insertion between the two groups (p = 0.952). Conclusion: This study demonstrated the superiority of apical peri-prostatic nerve block over intra rectal xylocaine gel instillation during TRUS-PBx with respect to its anesthetic efficacy. Therefore, centers providing TRUS-PBx in Nigeria should consider apical peri-prostatic nerve block as their mode of anesthesia for the procedure due to its efficacy and high safety profile.
Keywords: Apical, nerve block, peri-prostatic, prostate biopsy, ultrasound, xylocaine gel
|How to cite this article:|
Ezenwa E V, Osaghae S O, Ozah E O, Okparanta G. Apical peri-prostatic nerve block versus intra-rectal xylocaine gel for trans- rectal ultrasound guided prostate biopsy among Nigerian patients: A prospective randomized study. Niger J Clin Pract 2020;23:1183-7
|How to cite this URL:|
Ezenwa E V, Osaghae S O, Ozah E O, Okparanta G. Apical peri-prostatic nerve block versus intra-rectal xylocaine gel for trans- rectal ultrasound guided prostate biopsy among Nigerian patients: A prospective randomized study. Niger J Clin Pract [serial online] 2020 [cited 2021 Jan 27];23:1183-7. Available from: https://www.njcponline.com/text.asp?2020/23/9/1183/294676
| Introduction|| |
Trans-rectal ultrasound guided-prostate biopsy (TRUS-PBx) with extended core protocol is the gold standard for obtaining tissue for the diagnosis of prostate cancer., Increased number of cores during prostate biopsy when extended core protocol is used translates to increased pain felt during the procedure., Probe insertion and prostate capsular penetration are the two main causes of pain during Trans-rectal ultrasound guided biopsy of the prostate.
Various anesthetic methods have been employed during prostate biopsy, these includes xylocaine gel, caudal block, short acting inhalational anesthesia (Entonox), sedation, intravenous anesthesia like propofol, subarachnoid block and peri-prostatic block. Peri-prostatic nerve block (PPNB) with lidocaine injection has been shown to be the most effective method.
Periprostatic block involves the administration of lidocaine either at the base of the prostate (Mounts block) or the apex of the prostate. Nash et al. initially suggested bilateral injections at the junction of the base of the prostate and seminal vesicles. Soloway and Obeck proposed modified periprostatic nerve block recommending two or more injections on each side one beside the apex, between the apex and the base and at the base. Rodriquez et al. investigated infiltration only at the apex, the argument in favor of this technique was that neurovascular bundles pass along the posterolateral margins of the gland between capsule and Denonvillier's fascia. It pierces the capsule at the base and apex in 4 and 8 o'clock positions. Thus, anesthesia introduced at either point will suffice for the patient. The efficacy of apical infiltration only was confirmed by Rodriquez et al. who found that infiltrating lidocaine at each apex is enough to control pain. The main advantage of apical injection technique is its ease of use and requirement for one half amount of local anesthetic agent than what is needed for basal block.
In Nigeria, most centers still do digitally guided sextant biopsy during which xylocaine gel is the mode of anesthesia, but its efficacy when instilled trans-rectally is controversial.,, The use of ultrasound guidance during prostate biopsy is gradually gaining ground, with consequent increase in the number of cores as extended core protocol has been shown to give higher yield. The use of ultrasound guidance and extended core protocol has been shown to lead to more pain felt during the procedure.,
In this study, we compared the analgesic effect of apical peri-prostatic block against the commonly used intra-rectal xylocaine gel for prostate biopsy in Nigeria. This is to asses if the routinely used intra-rectal anesthetic gel is suitable for the TRUS-PBx protocol that is currently gaining ground in Nigeria.
| Methods|| |
This is a prospective randomized comparative study carried out over one year. It involved consecutive patients presenting at the outpatient urology clinic of University of Benin Teaching Hospital Edo State, Nigeria. Patients were randomized into two groups (A and B) by simple randomization method. Both the researcher and patients were blinded. The patients were counseled for the procedure and were also told that they will be given an anesthetic agent through the anus, but the type of anesthesia that will be administered was not disclosed to them. Also, the doctor that took the pain scores after the procedure was not aware of the nature of anesthesia that was administered.
Inclusion criteria are: Elevated prostate specific antigen (PSA) level and abnormal digital rectal examination. Exclusion criteria included: patients with painful anorectal conditions, bleeding diathesis, urethral strictures, and local anesthetic allergy.
All patients had a 5-day course of prophylactic antibiotics (ciprofloxacin and metronidazole) usually commenced a day prior to prostate biopsy. Patients were positioned in left lateral decubitus position.
With the patients in left lateral position, Group A (Xylocaine gel group) had 10 mls of 2% intra-rectal xylocaine gel instillation before biopsy. For Group B (Peri-prostatic block group), apical infiltration of 10 mls of 1% xylocaine (5 mls on each side) was carried out using a 25 cm length, 22 G size Geotek Chiba needle. This was guided using a 7.5 Hz, end firing Sonoscape rectal ultrasound probe with a well fitted needle guide which was also used for the biopsy.
Before administration of lidocaine, the prostate was pricked with a Chiba needle and the pain caused by the needle was noted by the patient. Successful deposition of anesthetic agent was confirmed when the injected xylocaine causes a separation of the prostate from the rectal wall which is seen on the screen of the ultrasound machine as ultrasonic wheal. Before commencement of tissue retrieval, the prostate was again pricked with the Chiba needle. Numbness over the prostate was considered to be a sign of successful anesthesia. This numbness was subsequently rated using a Numeric Pain Rating Score.
TRUS-guided 12 core prostate biopsy was carried out on both arms of the study after 5 minutes of anesthesia using 18G, 25 cm Geotek Estacore biopsy needle. Pain during insertion of rectal probe and capsular penetration were assessed immediately after completion of the procedure with an 11 point Numeric Pain Rating Scale (NPRS),, where 0 represents no pain and 10 represents worst pain imaginable.
Each patient was observed for an hour after biopsy before discharge. Patients were followed up in outpatient clinic for a month to assess for complications.
Data was collected using a researcher administered proforma and analyzed using statistical package for social sciences (SPSS) version 21.0. Results were expressed as mean ±± standard deviation and using figures and charts. Test of association was done using student t-test and Chi-square where appropriate. Level of significance was set at P < 0.05.
Ethical approval was obtained from the institutional Ethics Committee with protocol number ADME/E22/A/VOL.VII/14659. Written informed consent was also obtained from patients who participated in this study after counseling.
| Results|| |
The mean (SD) age of the study population was 68.6 ± 9.2 years. Patients in Group A were slightly younger (66.5 ± 8.7 years) than those in Group B (70.8 ± 9.3 years), P = 0.466. [Table 1]
Lower Urinary Tract Symptoms (LUTS) were common in both Group A (97.8%) and Group B (100.0%) study groups. The median (range) duration of symptoms was 36.0 (1-410) months in Group A and 24.0 (3-468) months in Group B block study group. Thirty (66.7%) patients in Group A and 25 (55.6%) in Group B were referred for biopsy based on both elevated PSA results and abnormal digital rectal examination findings (p = 0.515). Mean Quality of Life scores (QOL) of patients were higher among patients in Group B (4.46 ± 1.10) compared to Group A (4.27 ± 1.08). (p = 0.515). [Table 1]
The Mean (SD) PSA value for Group A was 54.0 ± 39.7 ng/ml while that for Group B was 50.0 ± 53.6 ng/ml, P = 0.916. [Table 2]
The Mean (SD) prostate volume for Group A was 74.4 ± 48.3 mls while that for the Group B was 75.4 ± 40.4 mls, P = 0.699. [Table 2]
There was no difference in the mean pain score during probe insertion between the two groups of the study population (p = 0.952). [Table 3]
There was a difference in the mean pain score during biopsy and post biopsy between Group A and Group B of the study population respectively (p < 0.0001). [Table 3]
There was no statistically significant difference in the complication rates between Group A and Group B (p > 0.05). [Table 4] None of the complications recorded required hospital admission.
A malignant histology outcome was obtained in 27 (64.3%) of patients in the Group A and 26 (59.1%) of patients in Group B. There was no statistically significant difference in proportions regarding the histological diagnosis between the two study groups (p = 0.662).
The Mean (SD) Gleason score was slightly higher in the Group B (6.6 ± 1.4) compared to the Group A (6.3 ± 1.3). (p = 0.553).
| Discussion|| |
Trans-rectal ultrasound guided biopsy of the prostate is a crucial procedure in the evaluation of patients for prostate cancer. However, tshis has been shown to be a very painful procedure which sometimes leads to refusal of the procedure especially when there is need for it to be repeated., This study compared the efficacy of apical infiltration of 1% xylocaine against the instillation of 2% xylocaine gel into the rectum for pain reduction during the procedure. The choice of apical block as against basal is because of the lesser volume of xylocaine required for the procedure and also the fact that it is a skill that is easy to acquire as its landmark during trans-rectal ultrasound scan is easily identifiable.
The clinical characteristics of the two groups [Table 1], [Table 2], [Table 3] were similar for all the assessed parameters (P > 0.05). This shows that the two groups were uniformly randomized. This is important as there is need to homogenize the clinical parameters of both groups to increase the accuracy of pain assessment between the two groups.
There was a statistically significant difference in the mean pain score during and one hour after biopsy between the two groups (p < 0.0001). The mean pain score was significantly higher for Group A when compared to the Group B. This is in keeping with the outcome of earlier studies,,, conducted mainly among the Caucasians which have shown the superiority of peri-prostatic block over xylocaine gel. This is also the outcome of a similar study conducted among one hundred and nine Nigerian men in which periprostatic nerve block was compared to caudal block, in that study, most of the subjects, 47 (83.9%) in the peri-prostatic block arm had pain which were mostly mild to moderate. The fact that apical block in this study provided significant pain reduction very suitable for the performance of prostate biopsy is of note in that it is easier to administer when compared to basal block. Therefore, the skill can easily be taught to doctors who carry out this procedure. Moreover, basal block has been shown to provide inferior anesthesia when compared with apical block.
There was no statistically significant difference in pain score recorded in both groups during probe insertion. This could be adduced to the fact that peri-prostatic block is done on the prostate after probe insertion. The fact that patients in both arms felt moderate pain during probe insertion further lays credence to existing literature on the fact that probe introduction causes significant pain and the need to reduce such pain during prostate biopsy., Agents that have been considered for pain reduction during rectal probe insertion include diclofenac suppository, lidocaine cream and lidocaine spray.
Complications necessitating hospital admission were not recorded in either group and there was no statistically significant difference in the complication rate between the two groups. Post biopsy hematuria and rectal bleeding were the commonest complications noted in the study, this is similar to what Madej and colleagues found in their study of complication rates following prostate biopsy. The fact that complication rates found in this study were low adds to existing literatures, that recommended trans-rectal ultrasound guided prostate biopsy as a safe procedure.
| Conclusion|| |
The findings of this study clearly demonstrated the superiority of apical periprostatic nerve block over intra rectal xylocaine gel instillation during TRUS-PBx with respect to its anesthetic efficacy. Therefore, centers providing TRUS-PBx in Nigeria should consider apical periprostatic nerve block as their mode of anesthesia for the procedure due to its efficacy and high safety profile. There is also a need to evaluate the best option for pain reduction during rectal probe insertion as pain was felt by participants of this study when this was inserted.
Our appreciation goes to all the members of the Urology Unit of the Department of Surgery, UBTH, Edo State, Nigeria for their support during data collection for the study.
Financial support and sponsorship
The project was supported by the scholarship fund obtained by Miss Gloria Okparanta from World Endourology Society Summer Scholarship Award for 2018. She is currently a five hundred level medical student of University of Benin Teaching Hospital, Edo State, Nigeria.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]