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Caudal anaesthesia vs lignocaine gel for TRUS biopsy of the prostate. A randomised controlled trial

A randomised study to investigate the effects of caudal lignocaine versus topical lignocaine on VAS pain scores in men undergoing trans-rectal ultrasound guided biopsy of the prostate for the detection of prostate cancer.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000102471
Enrollment
50
Registered
2007-01-31
Start date
2007-02-05
Completion date
Unknown
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

Trans-rectal ultrasound (TRUS) guided biopsy of the prostate is a routine method of testing for prostate cancer, which is one of the most common cancers affecting men. The procedure involves passing a probe into the rectum and guiding a needle into the prostate to obtain tissue. Usually 6 to 24 biopsies are taken and the ability to detect cancer improves with increasing biopsies. Pain relief for this procedure has ranges from nothing or local anaesthetic gel, when performed in the urologist’s room to full general anaesthesia when performed in hospital. Numerous studies have found that injection of local anaesthetic around the prostate improves pain relief and tolerance of the procedure. Caudal anaesthesia is a common method of providing pain relief. It is almost routinely used in children undergoing genital and lower abdominal surgery such as circumcision and hernia repair. It is also used in adults undergoing perianal surgery such as haemorrhoidectomy. Caudal anaesthesia involves injecting local anaesthetic into the caudal space. The caudal space is a continuation of the epidural space, a fatty layer around the spinal cord. This study will compare the pain relief provided by caudal anaesthesia with local anaesthetic gel in men undergoing TRUS guided biopsy of the prostate

Interventions

A single injection of 4mg / kg (ideal body weight) of 2% lignocaine (to a maximum of 400 mg) into the caudal epidural space prior to TRUS biopsy. A TRUS biopsy is usually completed within 15 - 20 minutes. Following the TRUS biopsy, subjects are cared for in the recovery room for a minimum of 30 minutes.

Sponsors

Dr Suzi Nou
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion: Adult patients undergoing TRUS biopsy of the prostate able to give consent.

Exclusion criteria

Allergy to lignocaine, known contraindication to neuraxial blockade (sepsis, abnormal spinal anatomy, bleeding diathesis)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026