Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management: A Randomized Controlled Trial of Efficacy and Safety

Conditions
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Cervical Cancer, Endometrial Cancer

Intervention / Treatment
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* Procedure: Superior Hypogastric Plexus Block
* Procedure: Ganglion Impar Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were assigned to two groups. Group 1: Patients with pelvic floor pain due to cervical and endometrial cancer who were treated with superior hypogastric plexus block. Group 2: Patients with pelvic floor pain due to cervical and endometrial cancer who were given ganglion impar block.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1: superior hypogastric plexus block group<br>Device: C-arm fluoroscopic device Drug: lidocaine + alcohol | Procedure: Superior Hypogastric Plexus Block<br>* 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.<br>|
| Experimental: group 2: ganglion impar block group<br>Device: C-arm fluoroscopic device Drug: lidocaine + alcohol | Procedure: Ganglion Impar Block<br>* this procedure uses a trans-sacrococcygeal approach by injecting 4 ml of 1% lidocaine + 6 ml of 96% alcohol and confirmed by C-arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale (NRS) | 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 | 3 month | 
| Oswestry Disability Index (ODI) | 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 | 3 Month | 
| Morphine equivalent daily dose (MEDD) | This is the dose that the patient takes regularly to relieve pain. | 3 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effect | It is an unwanted effect due to the intervention given to the patient. | 3 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Cancer, Perineal Pain, Endometrial Cancer, Superior Hypogastric Plexus Block, Ganglion Impar Block, pelvic pain