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Trial Title:
Interventions for the Management of Perineal Cancer Pain
NCT ID:
NCT06392399
Condition:
Cancer Rectum
Cancer Vulva
Cancer Vagina
Conditions: Official terms:
Cancer Pain
Conditions: Keywords:
cooled radiofrequency , conventional radiofrequency
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
cooled radiofrequency ,
Description:
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.
Arm group label:
Cooled radiofrequency
Intervention type:
Device
Intervention name:
conventional radiofrequency
Description:
In conventional RF group lesion will be performed at 80°C for 120 seconds.
Arm group label:
Conventional radiofrequency
Intervention type:
Device
Intervention name:
neurolysis of ganglion
Description:
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.
Arm group label:
Neurolytic block of Ganglion
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.
Criteria for eligibility:
Criteria:
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.
-
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
June 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06392399
