Efficacy of Diclofenac Suppository for Pain Control in Ultrasound Guided Biopsy of Prostate

Aga Khan University

Status and phase: Completed; Phase 2

Conditions: Carcinoma Prostate

Treatments: Drug: Diclofenac suppository plus lidocaine gel; Drug: Lidocaine gel only

Study type: Interventional

Funder types: Other

Identifiers

NCT01939743

11GS009SUR

Details and patient eligibility

About

Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode of investigation for prostate cancer in current urology practice. It is considered a minor procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the redo procedure without any analgesia or anesthesia but on the other hand, some authors reveal that 65 to 90% of patients report pain ranging from mild to severe in intensity. Diclofenac is a local and systemic anti-inflammatory drug and it reduces local mediators involved in local pain.The purpose of this study is to find out the role of rectal administration of diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating intra and post procedural pain in prostatic biopsy with adequately calculated sample size and excluding the patients with contraindication to procedure or diclofenac administration as these were the shortcomings of previous studies.

Enrollment: 100 patients

Sex: Male

Ages: 51 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:All male patients undergoing ultrasound guided prostate biopsy due to any one of the following:

• Raised prostate-specific antigen level (>4.0ng/ml) and palpable nodularity on digital rectal examination
• Palpable nodularity on digital rectal examination
• Hypo echoic lesion as compared to surrounding prostate on transrectal ultrasound

Exclusion Criteria:

• History of previous prostate biopsy
• Acute and/or chronic prostatitis or chronic pelvic pain syndrome
• Anal fissure, hemorrhoids, anal surgery
• Concomitant analgesic medication
• Chronic renal failure
• Allergy to diclofenac

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

diclofenac suppository plus lidocaine gel

Experimental group

Description:

Intervention Drug with local anaesthetic

Treatment:

Drug: Lidocaine gel only

Drug: Diclofenac suppository plus lidocaine gel

Lidocaine gel only

Other group

Description:

Used as local aneaethetic as a part of institutional prostate biopsy protocol

Treatment:

Drug: Lidocaine gel only