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.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621001143819

Enrollment

Registered

2021-08-25

Start date

2021-10-08

Completion date

2022-09-30

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 bef

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results