Interventions for the Management of Perineal Cancer Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Rectum Cancer Vulva Cancer Vagina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional radiofrequency

In this group we will use conventional radiofrequency thermocoagulation in the management of perineal cancer pain

Group Type ACTIVE_COMPARATOR

conventional radiofrequency

Intervention Type DEVICE

In conventional RF group lesion will be performed at 80°C for 120 seconds.

Cooled radiofrequency

In this group we will use cooled radiofrequency in the management of perineal cancer pain

Group Type ACTIVE_COMPARATOR

cooled radiofrequency ,

Intervention Type DEVICE

In Cooled RF, after placement of the introducer needle, the 18 gauge internally cooled RF electrode is used for 90 seconds at a temperature of 60°C.

Neurolytic block of Ganglion

In this group we will use neurolysis of ganglion impar in the management of perineal cancer pain

Group Type ACTIVE_COMPARATOR

neurolysis of ganglion

Intervention Type DEVICE

In neurolytic block, Once the position of the needle tip confirmed, 4 - 6 mL of 8% phenol in saline will be injected followed by 1 mL of saline to avoid the deposition of phenol within the intervertebral disc material.

Interventions

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cooled radiofrequency ,

In Cooled RF, after placement of the introducer needle, the 18 gauge internally cooled RF electrode is used for 90 seconds at a temperature of 60°C.

Intervention Type DEVICE

conventional radiofrequency

In conventional RF group lesion will be performed at 80°C for 120 seconds.

Intervention Type DEVICE

neurolysis of ganglion

In neurolytic block, Once the position of the needle tip confirmed, 4 - 6 mL of 8% phenol in saline will be injected followed by 1 mL of saline to avoid the deposition of phenol within the intervertebral disc material.

Intervention Type DEVICE

Eligibility Criteria

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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.

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Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No