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.
A multi-centre, randomised trial of periprostatic nerve block in transperineal prostate biopsy under general anaesthesia in patients with suspected prostate cancer.
Chris O Brien Lifehouse
50 participants
Oct 8, 2021
Interventional
Conditions
Summary
This study aims to determine if local anaesthetic injected around the prostate reduces pain after prostate biopsies under general anaesthesia. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are undergoing planned transperineal prostate biopsy for suspected prostate cancer. Study Details All participants in this study will undergo a transperineal prostate biopsy under general anaesthesia. This study will be completed in two parts: In part one, 10 participants will be recruited, and they will be placed into two groups by chance to receive a local anaesthetic periprostatic nerve block of 1% lignocaine with adrenaline or to receive no injection while under general anaesthetic. Depending on the results of this part of the study, we will determine whether a placebo is required for part 2 of this study. In part two, if results of part 1 show that a placebo is necessary for the study to continue, the trial will recruit 50 participants to receive the same injection as part 1 (1% lignocaine with adrenaline) or receive a placebo (non-active injection of normal saline). If results of part 1 show a placebo is not necessary, the trial will continue the same way and recruit 40 more participants. After the procedure, the participants will be asked to rate their worst level of pain and be monitored for additional analgesia and complications (if any). All participants will be recruited via clinics of and by the two treating surgeons with biopsies performed in the adjoining hospitals. It is hoped that this trial will provide information on patient reported outcomes to improve transperineal prostate biopsy techniques making them more tolerable, as patients may be expected to undergo more than one such procedures in the course of prostate cancer diagnosis and treatment.
Eligibility
Inclusion Criteria2
- Patients undergoing transperineal prostate biopsy.
- Patients who can provide informed consent for participation in this study.
Exclusion Criteria4
- Any patient who cannot provide informed consent or is unwilling to participate in this study.
- Any patient who has received a locoregional nerve block in the 24 hours prior to transperineal nerve block.
- Any patient with a history of anaphylaxis following local anaesthetic injection.
- 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.
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Interventions
All participants in this study will undergo transperineal prostate biopsy under general anaesthesia (GA) by an expert urologist as part of their diagnostic process for suspected prostate cancer. If randomised to the treatment group i.e. the periprostatic nerve block (PPNB) group, participants will receive an additional injection of weight-based 1% lignocaine with adrenaline (1:200000), 6-7mg/kg with maximum dose not to exceed 500mg (UofIowa protocol). This injection will be administered just before biopsy and after GA administration and is anticipated to provide at least 2 hours of analgesia. An uncomplicated biopsy procedure is estimated to take about 20-25 minutes.
Locations(2)
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ACTRN12621001143819