Interventions for the Management of Perineal Cancer Pain

Cooled Radiofrequency in Comparison to Either Conventional Radiofrequency Thermocoagulation or Neurolytic Block of Ganglion Impar in the Management of Perineal Cancer Pain

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06392399

Enrollment

Registered

2024-04-30

Start date

2024-06-30

Completion date

2026-06-30

Last updated

2024-05-02

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

Conditions

Cancer Rectum, Cancer Vulva, Cancer Vagina

Keywords

cooled radiofrequency , conventional radiofrequency

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.

Interventions

DEVICEcooled 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.

DEVICEconventional radiofrequency

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

DEVICEneurolysis 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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. \-

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 .

Other

Measure	Time frame	Description
Patient's satisfaction by the Global Perceived Effect questionnaire	at baseline, 2 weeks, 1 month, 3 months.	provides patient feedback on your empathy and relationship-building skills during consultations.

Contacts

Primary Contactaya ali

totaaboeldahab8@gmail.com01068744428

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026