Interventions for the Management of Perineal Cancer Pain

Assiut University

Status: Not yet enrolling

Conditions: Cancer Rectum; Cancer Vagina; Cancer Vulva

Treatments: Device: neurolysis of ganglion; Device: cooled radiofrequency ,; Device: conventional radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT06392399

18-2024-679

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Conventional radiofrequency

Active Comparator group

Description:

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

Treatment:

Device: conventional radiofrequency

Cooled radiofrequency

Active Comparator group

Description:

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

Treatment:

Device: cooled radiofrequency ,

Neurolytic block of Ganglion

Active Comparator group

Description:

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

Treatment:

Device: neurolysis of ganglion