Clinical trial NCT05427058: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Endometrial Cancer
Keywords: Perineal Pain
Cervical Cancer
Endometrial Cancer
Superior Hypogastric Plexus Block
Ganglion Impar Block
pelvic pain
Lead sponsor: University of Brawijaya
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Numerical rating scale (NRS)
timeFrame: 3 month
measure: Oswestry Disability Index (ODI)
timeFrame: 3 Month
measure: Morphine equivalent daily dose (MEDD)
timeFrame: 3 Month
Secondary outcomes:
measure: Adverse effect
timeFrame: 3 Month
Other outcomes:
Locations:
Study officials:
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