Interventions for the Management of Perineal Cancer Pain

Not Applicable

Not yet recruiting

• Conditions: Cancer Rectum; Cancer Vulva; Cancer Vagina
• Interventions: Device: cooled radiofrequency ,; Device: neurolysis of ganglion; Device: conventional radiofrequency

• Registration Number: NCT06392399
• Lead Sponsor: Assiut University

Brief Summary

Pain associated with neoplasms may be of somatic, visceral, or neuropathic origin.Visceral pain or pain that is mediated by the sympathetic fibers in the perineal area associated with malignancy in the pelvis may be effectively treated with neurolysis of impar ganglion.In recent years, radiofrequency lesioning of the ganglion Impar has evolved as a novel non pharmacological technique for the management of patients suffering from intractable perineal pain.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-04-30
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02
• Study Start: 2024-06
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Cancer patients aged from 20-70 years old, with lower third cancer rectum, caner vulva, cancer vagina and cancer perineum.
2. The intensity of perineal pain on VAS score ≥ 5.
3. Unsatisfactory treatment with tramadol (400 mg daily) , Pregabalin (150 mg daily) or presence of side effects of tramadol as headache, dizziness, constipation, rash, sweating, dry mouth.
4. Included participants should show adequate response to diagnostic ganglion impar block , i.e. reduction of VAS pain score > 50% at least for 2 hours.

Exclusion Criteria

1. Infection of the skin at or near site of needle puncture.

2. Coagulopathy or prolonged bleeding time.

3. Drug hypersensitivity or allergy to the studied drugs.

4. Central or peripheral neuropathy .

5. Significant organ dysfunction as respiratory , liver or renal failure.

6. Any psychiatric illness that would interfere with the perception and the assessment of pain.

7. Vertebral anomalies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cooled radiofrequency	cooled radiofrequency ,	In this group we will use cooled radiofrequency in the management of perineal cancer pain
Neurolytic block of Ganglion	neurolysis of ganglion	In this group we will use neurolysis of ganglion impar in the management of perineal cancer pain
Conventional radiofrequency	conventional radiofrequency	In this group we will use conventional radiofrequency thermocoagulation in the management of perineal cancer pain

Primary Outcome Measures

Name	Time	Method
Percentage of patients gaining ≥ 50% reduction of their pre procedural pain at VAS Score from baseline value.	2 hours, 24 hours,1 week, 2 weeks, 1 month, 3 months.	Patients rate pain on a scale from 0-10, 0 being no pain and 10 being the worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Total Tramadol consumption	at 2 weeks, 1 month, 2 months and 3 months' post procedural.	we will measure consumption of tramadol either it increasing or decreasing .