None listed
Conditions
Brief summary
Recent studies have found that PPNB anesthesia effectively relieves pain due to insertion of the biopsy needle into the prostate gland (actual biopsy) but it is ineffective in reducing the pain caused by probe insertion into the rectum during TRUS-guided prostate biopsy procedure. In this regard, if adjunct regimens are added prior to PPNB anesthesia, pain experienced during TRUS-guided prostate biopsy may be alleviated. The study purpose is to investigate the efficacy and safety of Tramadol alone or in combination with Parecoxib as adjuncts regimens to PPNB anesthesia in the management of pain during TRUS-guided prostate gland biopsy and compared to current gold standard procedure, PPNB anesthesia, alone.
Interventions
Arm 1: Urologist on duty for prostate biopsy procedure administered an intramuscular injection of Tramadol 100mg/ml, one hour prior to prostate biopsy procedure as adjunct regimen to the current gold standard of care method for preventing pain during transrectal ultrasound-guided biopsy, known as periprostatic nerve block (PPNB) anesthesia by injecting 10ml of Lidocaine 1% bilaterally at neurovascular bundles of prostate gland five minutes prior the actual biopsy process (obtaining of prostate c
Arm 1: Urologist on duty for prostate biopsy procedure administered an intramuscular injection of Tramadol 100mg/ml, one hour prior to prostate biopsy procedure as adjunct regimen to the current gold standard of care method for preventing pain during transrectal ultrasound-guided biopsy, known as periprostatic nerve block (PPNB) anesthesia by injecting 10ml of Lidocaine 1% bilaterally at neurovascular bundles of prostate gland five minutes prior the actual biopsy process (obtaining of prostate cores) of prostate biopsy procedure. Arm 2: Urologist on duty for prostate biopsy procedure administered the intramuscular injections of Tramadol 100mg/ml and Parecoxib 40mg/ml, one hour prior to prostate biopsy procedure as adjunct regimens to the current gold standard of care method for preventing pain during transrectal ultrasound-guided biopsy, known as periprostatic nerve block (PPNB) anesthesia by injecting 10ml of Lidocaine 1% bilaterally at neurovascular bundles of prostate gland five minutes prior the actual biopsy process (obtaining of prostate cores) of prostate biopsy procedure.
Sponsors
Xenofon Ouzounidis
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed