A randomised clinical trial comparing post-operative pain scores in patients with suspected prostate cancer undergoing transperineal prostate biopsy with and without a periprostatic nerve block under general anaesthesia.

Phase 2

Not yet recruiting

• Conditions: prostate cancer; transperineal prostate biopsy; post-operative pain; Cancer - Prostate; Surgery - Surgical techniques; Anaesthesiology - Pain management

• Registration Number: ACTRN12621001143819
• Lead Sponsor: Chris O Brien Lifehouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-25
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1.Patients undergoing transperineal prostate biopsy.
2.Patients who can provide informed consent for participation in this study.

Exclusion Criteria

1.Any patient who cannot provide informed consent or is unwilling to participate in this study.
2.Any patient who has received a locoregional nerve block in the 24 hours prior to transperineal nerve block.
3.Any patient with a history of anaphylaxis following local anaesthetic injection.
4.Any patient unable to communicate, read or write in English to a level where they are able to understand the study and consent to inclusion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative pain scores assessed using the 100mm Visual Analogue Scale (VAS)[Assessed once only after the biopsy procedure, after participant has been shifted to recovery and is fully awake and out of effects of general anaesthesia approximately 2 hours post-procedure and always within 24 hours. Participants will be asked to rate their worst level of pain they experienced post-procedure.]

Secondary Outcome Measures

Name	Time	Method
Rate and severity of post-operative complications as a composite outcome according to the Clavien-Dindo Classification. This data will be collected during the patients stay in recovery and visits to the ER/Doctors office after discharge, with conditions possibly associated with the biopsy procedure. Medical records will be screened to collect this data. [T1: recorded immediately after procedure till the participant is discharged. Participants are under constant watch till discharge and so specific timepoints i.e. 10 mins or 30 mins etc are not required. <br>T2: From participants' discharge from the hospital till up to 7 days post-procedure. ];use of additional analgesia post-operatively, in mg of morphine equivalent. Collected from medical records.[After the participant is moved out of the operating theatres and in to recovery until they are discharged from the hospital. This is usually a two hours window. ]