To compare efficacy of radiofrequency thermocoagulation of ganglion Impar versus block using a combination of local anaesthetic and steroid in chronic perineal pain patients and to assess pain relief and patient’s self reported belief about the efficacy of treatment

Not Applicable

Completed

• Conditions: Health Condition 1: R102- Pelvic and perineal pain

• Registration Number: CTRI/2022/05/042716
• Lead Sponsor: Pt B D Sharma PGIMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Forty patients of either sex in the age group of 20-70 years suffering from chronic perineal pain will be enrolled in the study. Patients fulfilling all the three criteria will be included in the study:

1) history, physical examination and pain pattern consistent with chronic perineal pain,

2) the cause of chronic perineal pain being benign in nature with malignancy ruled out and

3) failure to respond to six weeks of conservative treatment with a combination of analgesics, anti-inflammatory drugs, neuromodulators and physiotherapy.

Exclusion Criteria

Patients with

1) Known contraindications for nerve blocks in sacrococcygeal area

2) Active perineal infection

3) Acute perineal trauma

4) History of perineal malignancies

5) History of adverse reactions to local anaesthetics or steroids

6) Previous history of ganglion Impar blocks

7) Previous surgery for in perineal region

8) Uncontrolled diabetes mellitus

9) Anticoagulants intake

10) Pregnancy

will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of pain using pain scoreTimepoint: Thirty minutes before the procedure <br/ ><br>Thirty minutes after the procedure <br/ ><br>Two weeks after the procedure <br/ ><br>One month after the procedure <br/ ><br>Three months after the procedure <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC)Timepoint: Patient global impression of change will be assessed two weeks, one month and three months after the procedure