Cervical Cancer, Endometrial Cancer
Conditions
Keywords
Perineal Pain, Cervical Cancer, Endometrial Cancer, Superior Hypogastric Plexus Block, Ganglion Impar Block, pelvic pain
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.
Interventions
PROCEDURESuperior 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.
PROCEDUREGanglion 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.
Sponsors
University of Brawijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical rating scale (NRS) | 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 |
| Oswestry Disability Index (ODI) | 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 |
| Morphine equivalent daily dose (MEDD) | 3 Month | This is the dose that the patient takes regularly to relieve pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effect | 3 Month | It is an unwanted effect due to the intervention given to the patient. |
Countries
Indonesia
Contacts
Primary ContactRistiawan M Laksono, MD,FIPP
Outcome results
None listed