Comparing a combination of diltiazem gel, diclofenac suppository and nerve block vs nerve block for pain control during transrectal ultrasonography-guided biopsy of the prostate

Comparison of the efficacy of a combination of topical diltiazem gel, diclofenac suppository and periprostatic nerve block with periprostatic nerve block for periprocedural pain control during transrectal ultrasonography-guided biopsy of the prostate: A single blinded, double arm Randomized control trial - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082037

Enrollment

Registered

2025-03-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system

Interventions

Intervention1: combination of topical diltiazem gel and diclofenac suppository and periprostatic nerve block: Patients will receive combination of rectal administration of diclofenac 100 miligram, dil

Eligibility

Inclusion criteria

Inclusion criteria: All consented cases of age more than 18 years who are to have their first prostatic biopsy owing to clinical or biochemical suspicion of carcinoma prostate

Exclusion criteria

Exclusion criteria: a. History of active anal disease, anal fissures, haemorrhoids, rectal ulcers b. Chronic pelvic pain syndrome c. Active urinary tract infections d. Coagulopathies e. Neuropathies f. Uncontrolled diabetes g. Ingestion of aspirin or clopidogrel or any other antiplatelet drugs h. Recent use of narcotics and analgesics i. Known allergy to diltiazem or lignocaine j. Low systolic blood pressure ( k. Aggravated CHF, chronic kidney disease and chronic liver disease.

Design outcomes

Primary

Measure	Time frame
To compare the pain score of patients experiencing periprocedural pain in those receiving a combination of topical diltiazem gel, diclofenac suppository and periprostatic nerve block vs periprostatic nerve block for transrectal ultrasonography-guided biopsy of the prostate (Assessed by using standard ten-point visual analogue scale)Timepoint: At the time of procedure and at the end of procedure	—

Secondary

Measure	Time frame
To compare periprocedural bleeding per rectum between 2 groupsTimepoint: Until post procedure day 1;To compare post procedural urinary tract infection between 2 groupsTimepoint: Until post procedure day 7;To compare the effect of administration of a combination of topical diltiazem gel, diclofenac suppository & periprostatic nerve block vs periprostatic nerve block alone on duration of procedureTimepoint: compare total duration of procedure	—

Measure

Time frame

To compare periprocedural bleeding per rectum between 2 groupsTimepoint: Until post procedure day 1;To compare post procedural urinary tract infection between 2 groupsTimepoint: Until post procedure day 7;To compare the effect of administration of a combination of topical diltiazem gel, diclofenac suppository & periprostatic nerve block vs periprostatic nerve block alone on duration of procedureTimepoint: compare total duration of procedure

—

Countries

India

Contacts

Public ContactSuman Sahoo

All India Institute of Medical Sciences, Bhubaneswar

urol_prasant@aiimsbhubaneswar.edu.in9494697071

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026