Local anaesthesia for transperineal prostate biopsy – a randomised control trial

Effect of local anaesthesia for transperineal prostate biopsy on post-procedure pain scores – a randomised control trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001310459

Enrollment

155

Registered

2016-09-19

Start date

2016-09-14

Completion date

2017-01-01

Last updated

2020-01-13

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 whether the infiltration of local anaesthetic following transperineal prostate biopsy significantly reduces pain scores as determined by VAS and short McGill pain questionnaire. Who is it for? You may be eligible to join this study if you are a male aged 50 years or above and are undergoing transperineal prostate biopsy. Study details Men will be allocated into 2 groups by chance, a treatment group and a control group. Men in the treatment group will receive infiltration of local anaesthetic (20mls of 0.5% bupivacaine) into the perineal skin after prostate biopsy. Men in the control group will receive no intervention. Data to be collected will be VAS and short McGill pain questionnaire forms 30 minutes following the procedure (to be filled out by the patient). The design of this study (RCT) will enable data collection and analysis to determine whether or not infiltration of local anaesthetic at the time of transperineal prostate biopsy is effective. That is, does it reliably reduce pain scores (VAS and short McGill pain questionnaire) and are the results statistically significant.

Interventions

1. Prospective, single blinded, randomised control trial 2. The population to be studied is men undergoing transperineal prostate biopsy under general anaesthesia. 3. This will be a multi-centre national study. 4. Men will be randomised into 2 groups, a treatment group and a control group. 5. All patients undergoing the procedure are put under general anaesthesia. 6. Men in the treatment group will receive infiltration of local anaesthetic (20mls of 0.5% bupivacaine, once only) into the perineal skin by the treating surgeon at the end of the procedure but prior to the patient being woken from general anaesthesia. 7. Men in the control group will receive no intervention 8. The design of this study (RCT) will enable data collection and analysis to determine whether or not infiltration of local anaesthetic at the time of transperineal prostate biopsy is effective. That is, does it reliably reduce pain scores (VAS and short McGill pain questionnaire) and are the results statistically significant.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

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

Eligibility

Sex/Gender

Male

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

Men who are undergoing transperineal prostate biopsy will be included in this study

Exclusion criteria

Participants will be considered ineligible if there is a contraindication to infiltration of local anaesthetic (e.g. allergy or previous adverse drug reaction) or they are unable to give informed consent.

Outcome results