Health TrialsbyHealthPanel

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

ConditionsCervical CancerEndometrial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Brawijaya

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Superior Hypogastric Plexus Block

    Procedure/Surgery

    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/Surgery

    this procedure uses a trans-sacrococcygeal approach by injecting 4 ml of 1% lidocaine + 6 ml of 96% alcohol and confirmed by C-arm.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: group 1: superior hypogastric plexus block groupActive comparator 1 intervention
Group B: group 2: ganglion impar block groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 month
2

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

Time frame
3 Month
3

Morphine equivalent daily dose (MEDD)

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

Time frame
3 Month

Secondary outcomes

1

Adverse effect

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

Time frame
3 Month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Brawijaya

Lead sponsor

Source ClinicalTrials.gov
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