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

NCT05427058 | Recruiting DMC

• 1 other identifier: UB_WWN01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Cancer; Endometrial Cancer

Keywords

Perineal Pain; Cervical Cancer; Endometrial Cancer; Superior Hypogastric Plexus Block; Ganglion Impar Block; pelvic pain

Outcome Measures

Primary Outcomes (3)

• 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

  3 month

• 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

  3 Month

• Morphine equivalent daily dose (MEDD)

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

  3 Month

Secondary Outcomes (1)

• Adverse effect

  3 Month

Study Arms (2)

group 1: superior hypogastric plexus block group

ACTIVE COMPARATOR

Device: C-arm fluoroscopic device Drug: lidocaine + alcohol

Procedure: Superior Hypogastric Plexus Block

group 2: ganglion impar block group

EXPERIMENTAL

Device: C-arm fluoroscopic device Drug: lidocaine + alcohol

Procedure: Ganglion Impar Block

Interventions

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.

group 1: superior hypogastric plexus block group

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.

group 2: ganglion impar block group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Brawijaya: lead

Study Sites (1)

General Hospital Saiful Anwar Malang

Malang, East Java, 65111, Indonesia

RECRUITING

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MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Pelvic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Ristiawan M Laksono

  Brawijaya University

  PRINCIPAL INVESTIGATOR

• Andika B Effendi

  Brawijaya University

  STUDY DIRECTOR

Central Study Contacts

Ristiawan M Laksono, MD,FIPP

CONTACT

+6281233773593; ristiawanm@ub.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: June 22, 2022
• Study Start: July 23, 2024
• Primary Completion: September 30, 2025
• Study Completion: January 30, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

ID (1)