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NCT Number: NCT05427058

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

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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Key information

Conditions

Cervical Cancer Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital Saiful Anwar Malang

Malang, East Java, 65111, Indonesia

Location status: Recruiting

Location contact

Fa'urinda R Prabu Nery, S1

CONTACT

[email protected]

+62 813-3617-2271

Ristiawan M Laksono, Specialist

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Superior hypogastric plexus block

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.

Ganglion Impar Block

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.

Primary outcomes

  1. Numerical rating scale (NRS)

    Time frame: 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

  2. Oswestry Disability Index (ODI)

    Time frame: 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

  3. Morphine equivalent daily dose (MEDD)

    Time frame: 3 Month

    This is the dose that the patient takes regularly to relieve pain.

Secondary outcomes

  1. Adverse effect

    Time frame: 3 Month

    It is an unwanted effect due to the intervention given to the patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Ristiawan M Laksono, MD,FIPP

CONTACT

[email protected]

+6281233773593

Sponsors and collaborators

Lead sponsor

University of Brawijaya

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 22, 2022
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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