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

July 7, 2025 updated by: Ristiawan Muji Laksono, MD, University of Brawijaya

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • East Java
      • Malang, East Java, Indonesia, 65111
        • Recruiting
        • General Hospital Saiful Anwar Malang
        • Contact:
        • Principal Investigator:
          • Ristiawan M Laksono, Specialist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1: superior hypogastric plexus block group
Device: C-arm fluoroscopic device Drug: lidocaine + alcohol
Procedure: 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.
Experimental: group 2: ganglion impar block group
Device: C-arm fluoroscopic device Drug: lidocaine + alcohol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 month
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 Month
Morphine equivalent daily dose (MEDD)
Time Frame: 3 Month
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
Time Frame: 3 Month
It is an unwanted effect due to the intervention given to the patient.
3 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brawijaya

Investigators

  • Principal Investigator: Ristiawan M Laksono, Brawijaya University
  • Study Director: Andika B Effendi, Brawijaya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UB_WWN01

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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