Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management
Primary Purpose
Cervical Cancer, Endometrial Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Superior Hypogastric Plexus Block
Ganglion Impar Block
Sponsored by
About this trial
This is an interventional supportive care trial for Cervical Cancer focused on measuring Perineal Pain, Cervical Cancer, Endometrial Cancer, Superior Hypogastric Plexus Block, Ganglion Impar Block, pelvic pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
group 1: superior hypogastric plexus block group
group 2: ganglion impar block group
Arm Description
Device: C-arm fluoroscopic device Drug: lidocaine + alcohol
Device: C-arm fluoroscopic device Drug: lidocaine + alcohol
Outcomes
Primary Outcome Measures
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
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
Morphine equivalent daily dose (MEDD)
This is the dose that the patient takes regularly to relieve pain.
Secondary Outcome Measures
Adverse effect
It is an unwanted effect due to the intervention given to the patient.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05427058
Brief Title
Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management
Official Title
Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management: A Randomized Controlled Trial of Efficacy and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brawijaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Endometrial Cancer
Keywords
Perineal Pain, Cervical Cancer, Endometrial Cancer, Superior Hypogastric Plexus Block, Ganglion Impar Block, pelvic pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1: superior hypogastric plexus block group
Arm Type
Active Comparator
Arm Description
Device: C-arm fluoroscopic device Drug: lidocaine + alcohol
Arm Title
group 2: ganglion impar block group
Arm Type
Experimental
Arm Description
Device: C-arm fluoroscopic device Drug: lidocaine + alcohol
Intervention Type
Procedure
Intervention Name(s)
Superior Hypogastric Plexus Block
Intervention Description
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
Intervention Name(s)
Ganglion Impar Block
Intervention Description
this procedure uses a trans-sacrococcygeal approach by injecting 4 ml of 1% lidocaine + 6 ml of 96% alcohol and confirmed by C-arm.
Primary Outcome Measure Information:
Title
Numerical rating scale (NRS)
Description
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
Time Frame
3 month
Title
Oswestry Disability Index (ODI)
Description
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
Time Frame
3 Month
Title
Morphine equivalent daily dose (MEDD)
Description
This is the dose that the patient takes regularly to relieve pain.
Time Frame
3 Month
Secondary Outcome Measure Information:
Title
Adverse effect
Description
It is an unwanted effect due to the intervention given to the patient.
Time Frame
3 Month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ristiawan Muji Laksono, MD,FIPP
Phone
+6281233773593
Email
ristiawanm@ub.ac.id
12. IPD Sharing Statement
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Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management
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