Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management
NCT ID: NCT05427058
Last Updated: 2025-07-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
36 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-07-23
Study Completion Date
2026-01-30
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
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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.
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.
Conditions
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Cervical Cancer
Endometrial Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
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.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Participant and Investigator masking:
The random order of the groups will be written on paper and hidden by using a sealed envelope with consecutive numbers. This envelope will be retained by personnel who are not involved in the care or evaluation of the patient, or the analysis of the data.
During the action, doctors and nurses are prohibited from communicating with participants regarding the actions given.
Outcomes assessor masking:
All data collection will be carried out by residents as research assistants who are trained for data collection. The assistant was not told what intervention was given to the patient, data collection was done directly by asking the patient without looking at the patient's status. The data that has been collected will be entered and processed by personnel outside the research team to ensure blinding.
The random order of the groups will be written on paper and hidden by using a sealed envelope with consecutive numbers. This envelope will be retained by personnel who are not involved in the care or evaluation of the patient, or the analysis of the data.
During the action, doctors and nurses are prohibited from communicating with participants regarding the actions given.
Outcomes assessor masking:
All data collection will be carried out by residents as research assistants who are trained for data collection. The assistant was not told what intervention was given to the patient, data collection was done directly by asking the patient without looking at the patient's status. The data that has been collected will be entered and processed by personnel outside the research team to ensure blinding.
Study Groups
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group 1: superior hypogastric plexus block group
Device: C-arm fluoroscopic device Drug: lidocaine + alcohol
Group Type
ACTIVE_COMPARATOR
Superior Hypogastric Plexus Block
Intervention Type
PROCEDURE
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.
group 2: ganglion impar block group
Device: C-arm fluoroscopic device Drug: lidocaine + alcohol
Group Type
EXPERIMENTAL
Ganglion Impar Block
Intervention Type
PROCEDURE
this procedure uses a trans-sacrococcygeal approach by injecting 4 ml of 1% lidocaine + 6 ml of 96% alcohol and confirmed by C-arm.
Interventions
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Superior Hypogastric Plexus Block
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.
Intervention Type
PROCEDURE
Ganglion Impar Block
this procedure uses a trans-sacrococcygeal approach by injecting 4 ml of 1% lidocaine + 6 ml of 96% alcohol and confirmed by C-arm.
Intervention Type
PROCEDURE
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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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University of Brawijaya
OTHER
Sponsor Role
lead
Responsible Party
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Ristiawan Muji Laksono, MD
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ristiawan M Laksono
Role: PRINCIPAL_INVESTIGATOR
Brawijaya University
Andika B Effendi
Role: STUDY_DIRECTOR
Brawijaya University
Locations
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General Hospital Saiful Anwar Malang
Malang, East Java, Indonesia
Site Status
RECRUITING
Countries
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Indonesia
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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UB_WWN01
Identifier Type: -
Identifier Source: org_study_id
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