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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
University of Brawijaya
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    March 29, 2022
    Last Updated
    June 16, 2022
    Sponsor
    University of Brawijaya
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    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

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

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