Efficacy and safety of three different analgesic methods for patients undergoing transrectal ultrasound-guided prostate biopsy: a prospective, randomized controlled trial.

Phase 2

Completed

• Conditions: Renal and Urogenital - Other renal and urogenital disorders; Prostate cancer; Pain relief; Cancer - Prostate

• Registration Number: ACTRN12619001760167
• Lead Sponsor: Xenofon Ouzounidis

Brief Summary

The pain during TRUS-guided biopsy of prostate gland is cumulative in nature and has a 3-fold origin: (i) the pain during insertion of the ultrasonography probe into the rectum, which is due to the stretching of the anal sphincter; (ii) the pain during needle puncture while depositing the local anesthetic at the PPNB site, as well as (iii) the pain during insertion of biopsy needle into prostate gland for the collection of multiple prostate biopsy cores (actual biopsy). Recent studies have found that PPNB anesthesia effectively reduces the pain due to the insertion of the biopsy needle into prostate gland (actual biopsy) but it is ineffective in reducing the pain during insertion of ultrasound probe into the rectum. Another study has shown that the pain caused by anesthetic infiltration at PPNB site can be comparable to or even worse than that of actual biopsy itself. In this regard, if adjunct regimens are added prior to PPNB anesthesia, pain due to aforementioned reasons might be alleviated. Therefore, we investigated the efficacy and safety of Tramadol alone or in combination with Parecoxib, as adjunct regimens to PPNB anesthesia for the management of pain during TRUS-guided biopsy of prostate gland and we compared it to the current gold standard method, PPNB, alone. Our findings indicate that intramuscular injection of 100 mg tramadol as adjunct regimen to PPNB anesthesia is a simple and safe technique that provides significant analgesic effect during TRUS-guided prostate biopsy, especially at the time of ultrasound probe insertion into rectum and at lidocaine infiltration at PPNB site. The effect size was proved to be even higher when tramadol is combined to intramuscular injection of 40 mg parecoxib before the PPNB anesthesia.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-03-18
• Study Start: 2019-12-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 51

Inclusion Criteria

All consecutive patients referred to Urology Department for early detection of prostate cancer due to increased serum PSA, and/or abnormal digital rectal examination or transrectal ultrasound-guided findings were considered eligible for the present study.

Exclusion Criteria

Exclusion criteria were: history of previous prostate biopsy, active anorectal pathology (anal fissures, strictures, hemorrhoids), chronic prostatitis/pelvic pain syndrome, concomitant analgesic medication, known allergy to investigating analgesic regimens, contraindications to NSAIDs such as gastric or duodenal ulcers, patients with bleeding diathesis and those with impaired intellectual ability.

Study & Design

• Study Type: Interventional
• Study Design: Not specified