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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05427058
• Other study ID #: UB_WWN01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2022
• Source: University of Brawijaya
• Contact: Ristiawan Muji Laksono, MD,FIPP
• Phone: +6281233773593
• Email: ristiawanm[@]ub.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: April 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain
• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Ganglion Cysts
• Uterine Cervical Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Brawijaya

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Morphine equivalent daily dose (MEDD)	This is the dose that the patient takes regularly to relieve pain.	3 Month
Secondary	Adverse effect	It is an unwanted effect due to the intervention given to the patient.	3 Month