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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1: superior hypogastric plexus block group | Active Comparator | Device: C-arm fluoroscopic device Drug: lidocaine + alcohol |
|
| group 2: ganglion impar block group | Experimental | Device: C-arm fluoroscopic device Drug: lidocaine + alcohol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effect | It is an unwanted effect due to the intervention given to the patient. | 3 Month |
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Inclusion Criteria:
Exclusion Criteria:
Drop-out Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ristiawan M Laksono, MD,FIPP | Contact | +6281233773593 | ristiawanm@ub.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Ristiawan M Laksono | Brawijaya University | Principal Investigator |
| Andika B Effendi | Brawijaya University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Saiful Anwar Malang | Recruiting | Malang | East Java | 65111 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28613745 | Background | Fowler JR, Maani EV, Dunton CJ, Gasalberti DP, Jack BW. Cervical Cancer. 2023 Nov 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK431093/ | |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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.
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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.
| 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. |
|
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |