Interventions for the Management of Perineal Cancer Pain

May 1, 2024 updated by: Aya Abo eldahab Ali elden, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional radiofrequency
In this group we will use conventional radiofrequency thermocoagulation in the management of perineal cancer pain
Device: conventional radiofrequency
In conventional RF group lesion will be performed at 80°C for 120 seconds.
Active Comparator: Neurolytic block of Ganglion
In this group we will use neurolysis of ganglion impar in the management of perineal cancer pain
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.
Active Comparator: Cooled radiofrequency
In this group we will use cooled radiofrequency in the management of perineal cancer pain
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients gaining ≥ 50% reduction of their pre procedural pain at VAS Score from baseline value.
Time Frame: 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.
2 hours, 24 hours,1 week, 2 weeks, 1 month, 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Tramadol consumption
Time Frame: at 2 weeks, 1 month, 2 months and 3 months' post procedural.
we will measure consumption of tramadol either it increasing or decreasing .
at 2 weeks, 1 month, 2 months and 3 months' post procedural.

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: aya ali, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-2024-679

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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