Interventions for the Management of Perineal Cancer Pain

NCT06392399 | Not Yet Recruiting

• 1 other identifier: 18-2024-679
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer Rectum; Cancer Vulva; Cancer Vagina

Keywords

cooled radiofrequency , conventional radiofrequency

Outcome Measures

Primary Outcomes (1)

• Percentage of patients gaining ≥ 50% reduction of their pre procedural pain at VAS Score from baseline value.

  Patients rate pain on a scale from 0-10, 0 being no pain and 10 being the worst pain imaginable.

  2 hours, 24 hours,1 week, 2 weeks, 1 month, 3 months.

Secondary Outcomes (1)

• Total Tramadol consumption

  at 2 weeks, 1 month, 2 months and 3 months' post procedural.

Other Outcomes (1)

• Patient's satisfaction by the Global Perceived Effect questionnaire

  at baseline, 2 weeks, 1 month, 3 months.

Study Arms (3)

Conventional radiofrequency

ACTIVE COMPARATOR

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

Device: conventional radiofrequency

Cooled radiofrequency

ACTIVE COMPARATOR

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

Device: cooled radiofrequency ,

Neurolytic block of Ganglion

ACTIVE COMPARATOR

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

Device: neurolysis of ganglion

Interventions

cooled radiofrequency , 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.

Cooled radiofrequency

conventional radiofrequency DEVICE

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

Conventional radiofrequency

neurolysis of ganglion 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.

Neurolytic block of Ganglion

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients aged from 20-70 years old, with lower third cancer rectum, caner vulva, cancer vagina and cancer perineum.
• The intensity of perineal pain on VAS score ≥ 5.
• 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.
• Included participants should show adequate response to diagnostic ganglion impar block , i.e. reduction of VAS pain score \> 50% at least for 2 hours.

You may not qualify if:

• Infection of the skin at or near site of needle puncture.
• Coagulopathy or prolonged bleeding time.
• Drug hypersensitivity or allergy to the studied drugs.
• Central or peripheral neuropathy .
• Significant organ dysfunction as respiratory , liver or renal failure.
• Any psychiatric illness that would interfere with the perception and the assessment of pain.
• Vertebral anomalies.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Rectal Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vaginal Diseases

Study Officials

• aya ali

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

aya ali

CONTACT

01068744428; totaaboeldahab8@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aya Abo Eldahab

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 2, 2024

Record last verified: 2024-04