Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management
- Conditions
- Cervical CancerEndometrial Cancer
- Interventions
- Procedure: Superior Hypogastric Plexus BlockProcedure: Ganglion Impar Block
- Registration Number
- NCT05427058
- Lead Sponsor
- University of Brawijaya
- Brief Summary
This study compared the efficacy and safety of superior hypogastric plexus block and ganglion impar block procedures on the management of pelvic and perineal cancer pain in patients with cervical and endometrial cancer
- Detailed Description
Superior hypogastric plexus block is a commonly used method for the management of pelvic and perineal pain due to cancer, this procedure uses a transdiscal approach at the level of the L5-S1 vertebrae by injecting 5 ml of 1% lidocaine + 10 ml of 96% alcohol and confirmed by C-arm.
Compared with the ganglion impar block procedure using a trans-sacrococcygeal approach by injecting 4 ml of 1% lidocaine + 6 ml of 96% alcohol and confirmed by C-arm. The aim of this study was to compare the efficacy and safety of the ganglion impar block procedure against the superior hypogastric plexus block which is commonly used in the management of pelvic and perineal pain due to cervical and endometrial cancer.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 36
- Unbearable cancer pain that is resistant to WHO (World Health Organization) pain ladder at least 2 weeks medication
- The patient is tired of taking medication orally or complications of current medication (respiratory depression, nausea, vomiting, opioid-induced constipation, gastrointestinal disturbances)
- Patients with pelvic floor pain diagnosed by a (Fellow of Interventional Pain Practice) FIPP-certified pain specialist
- Patients with pain in the perineum diagnosed by a FIPP-certified pain specialist
- Numerical Rating Scale >4
- >18 years old
- Able and willing to sign an informed consent
- Refuse to be included in the research
- Blood clotting disorders (including taking anticoagulant drugs)
- Local infection in the area of action
- Loss to follow up
Drop-out Criteria:
- Loss to follow up
- Intervention complications occur
- Failed intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 1: superior hypogastric plexus block group Superior Hypogastric Plexus Block Device: C-arm fluoroscopic device Drug: lidocaine + alcohol group 2: ganglion impar block group Ganglion Impar Block Device: C-arm fluoroscopic device Drug: lidocaine + alcohol
- Primary Outcome Measures
Name Time Method Morphine equivalent daily dose (MEDD) 3 Month This is the dose that the patient takes regularly to relieve pain.
Numerical rating scale (NRS) 3 month Used to measure pain relief with a value of 0-10 (0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = most severe pain). The average pain intensity felt by the patient in the last 1 week
Oswestry Disability Index (ODI) 3 Month The Oswestry Disability Index is a measuring tool to evaluate the quality of life and the level of disability. In this study, we will use the Indonesian adaptation version. in a journal published by Phedy et al showed that the Indonesian version of the ODI retains the reliability, validity, and psychometric characteristics of the original ODI.
There are 10 main questions with 6 assessment options from the lowest point of 0 and the highest point of 5.
0-20%: mild disability 21-40%: moderate disability, affecting activities can still be overcome 41-60%: severe disability, pain is a major problem and interferes with activities 61-80%: patients experience disturbances in major aspects of life requiring intervention 81-100%: the patient is confined to bed because of complaints
- Secondary Outcome Measures
Name Time Method Adverse effect 3 Month It is an unwanted effect due to the intervention given to the patient.