Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Early ganglion impar block with neurolysis plus conventional analgesia: Ganglion impar block performed within 48 hours of randomization under ultrasound guidance with fluoroscopy if req
Sponsors
All India Institute of Medical Sciences, Nagpur
Eligibility
Inclusion criteria
Inclusion criteria: Adult women aged 18 years or older. Histologically or cytologically confirmed gynaecological malignancy involving the cervix, ovary, uterus, vagina or vulva with pelvic or perineal involvement of at least advanced stage. Moderate to severe chronic pelvic or perineal cancer pain with Numeric Rating Scale score of at least 4 for at least one month in the perineal or distal pelvic distribution consistent with the ganglion impar territory. Pain refractory to WHO Step 2 analgesics. Platelet count at least 50000 per microlitre. International Normalized Ratio not more than 1.5 in participants not receiving anticoagulants. Serum creatinine not more than 1.5 milligrams per decilitre or estimated glomerular filtration rate at least 60 millilitres per minute per 1.73 square metres. Serum AST and ALT not more than three times the upper limit of normal. Serum bilirubin not more than 1.5 times the upper limit of normal. Able to understand the study, provide written informed consent and comply with study procedures and follow up. Able to understand and speak at least one of the following languages English, Hindi, or Marathi
Exclusion criteria
Exclusion criteria: Allergy to local anaesthetics or contrast agents. Local or systemic infection. Uncorrectable coagulopathy. Anatomical barriers preventing safe ganglion impar block. Previous failed ganglion impar block. Predominantly non cancer pain. Unresponsive neuropathic pain. Brain metastases with clinical instability. Uncontrolled psychiatric illness. Pelvic neurolysis within the previous three months. Pelvic radiotherapy or pelvic surgery within the previous four weeks. Uncontrolled hypertension with repeated blood pressure readings greater than 140 over 90 millimetres of mercury. Clinically significant arrhythmia. Myocardial infarction within the previous six months. Pregnant or breastfeeding women. Participation in another interventional pain trial within the previous thirty days. Unable to comply with follow up. Any condition that, in the opinion of the investigator, makes participation unsafe.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity measured using the Numeric Rating Scale from baseline to one month after randomization.Timepoint: Baseline and one month after randomization. The one month assessment will be performed between 23 and 37 days after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life assessed using EORTC QLQ-C30.Timepoint: Baseline and one month after randomization, with assessment performed between 23 and 37 days.;Daily oral morphine equivalent dose and percentage reduction from baseline.Timepoint: Daily for 30 days after randomization.;Neuropathic pain burden assessed using the S-LANSS score.Timepoint: Baseline and one month after randomization, with assessment performed between 23 and 37 days.;Proportion of participants with S-LANSS score of 12 or higher.Timepoint: One month after randomization.;Functional status assessed using ECOG Performance Status and Activities of Daily Living.Timepoint: Baseline and one month after randomization.;Procedure related and opioid related adverse events.Timepoint: Throughout the study until one month follow up.;Longitudinal Numeric Rating Scale pain scores, pain relief measures and breakthrough pain frequency.Timepoint: Baseline, immediate post procedure, 24 hours and one month after randomization;Time to stable pain control defined as three consecutive days with Numeric Rating Scale score not more than 3.Timepoint: From randomization until achievement of stable pain control or one month.;Healthcare utilization and cost effectiveness.Timepoint: One month after randomization.;Proportion of participants achieving treatment success, defined as at least 50 percent reduction in Numeric Rating Scale pain score from baseline or a final Numeric Rating Scale pain score of not more than 3.Timepoint: One month after randomization, with assessment performed between 23 and 37 days. | — |
Countries
India
Contacts
Public ContactDr Akshara Ashok
All India Institute of Medical Sciences, Nagpur
Outcome results
None listed