Cervical CancerNCT05427058
Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management
A study testing Superior Hypogastric Plexus Block and Ganglion Impar Block in people with Cervical Cancer and Endometrial Cancer, run by University of Brawijaya at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer
- What is being tested?
- Superior Hypogastric Plexus Block and Ganglion Impar Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Jul 2024to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
General Hospital Saiful Anwar Malang
Malang, East Java, 65111
Fa'urinda R Prabu Nery, S1, +62 813-3617-2271, neririam@gmail.com
Ristiawan M Laksono, Specialist
About this study
Official title: Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management: A Randomized Controlled Trial of Efficacy and Safety
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
Read the 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.
- Conditions
- Cervical Cancer, Endometrial Cancer
- Being tested
- Superior Hypogastric Plexus Block, Ganglion Impar Block
- Keywords
- Perineal Pain, Cervical Cancer, Endometrial Cancer, Superior Hypogastric Plexus Block, Ganglion Impar Block, pelvic pain
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior Hypogastric Plexus BlockProcedure or 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 BlockProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| group 1: superior hypogastric plexus block group | Active comparator | Device: C-arm fluoroscopic device Drug: lidocaine + alcohol Receives: Procedure: Superior Hypogastric Plexus Block |
| group 2: ganglion impar block group | Experimental | Device: C-arm fluoroscopic device Drug: lidocaine + alcohol Receives: Procedure: Ganglion Impar Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 Month
Morphine equivalent daily dose (MEDD)
This is the dose that the patient takes regularly to relieve pain.
Measured: 3 Month
Secondary outcomes (1)
Adverse effect
It is an unwanted effect due to the intervention given to the patient.
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start23 Jul 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brawijaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ristiawan Muji Laksono, MD, University of Brawijaya
- Investigators
- Ristiawan M Laksono, Principal investigator, Brawijaya UniversityAndika B Effendi, Study director, Brawijaya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427058
- Sponsor's protocol ID
- UB_WWN01
- Status last verified
- Jul 2025
- First submitted
- 29 Mar 2022
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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/
PubMed 28613745Vrachnis N, Iavazzo C, Salakos N, Papamargaritis E, Boutas I, Creatsas G. Uterine tamponade balloon for the management of massive hemorrhage during cesarean section due to placenta previa/increta. Clin Exp Obstet Gynecol. 2012;39(2):255-7.
PubMed 22905480Yoon SY, Oh J. Neuropathic cancer pain: prevalence, pathophysiology, and management. Korean J Intern Med. 2018 Nov;33(6):1058-1069. doi: 10.3904/kjim.2018.162. Epub 2018 Jun 25.
PubMed 29929349Schmidt BL, Hamamoto DT, Simone DA, Wilcox GL. Mechanism of cancer pain. Mol Interv. 2010 Jun;10(3):164-78. doi: 10.1124/mi.10.3.7.
PubMed 20539035Bhatnagar S, Gupta M. Evidence-based Clinical Practice Guidelines for Interventional Pain Management in Cancer Pain. Indian J Palliat Care. 2015 May-Aug;21(2):137-47. doi: 10.4103/0973-1075.156466.
PubMed 26009665Gunduz OH, Kenis-Coskun O. Ganglion blocks as a treatment of pain: current perspectives. J Pain Res. 2017 Dec 14;10:2815-2826. doi: 10.2147/JPR.S134775. eCollection 2017.
PubMed 29276402Khan MA, Ashrafi SH, Decker SJ. The hepatic ultrastructure of chlordene-fed pigeons. Arch Environ Contam Toxicol. 1977;5(4):385-402. doi: 10.1007/BF02220919.
PubMed 196561Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.
PubMed 32694387Tunio M, Al Asiri M, Bayoumi Y, Abdullah O Balbaid A, AlHameed M, Gabriela SL, Amir O Ali A. Lumbosacral plexus delineation, dose distribution, and its correlation with radiation-induced lumbosacral plexopathy in cervical cancer patients. Onco Targets Ther. 2014 Dec 23;8:21-7. doi: 10.2147/OTT.S71086. eCollection 2015.
PubMed 25565862Leslie KK, Thiel KW, Goodheart MJ, De Geest K, Jia Y, Yang S. Endometrial cancer. Obstet Gynecol Clin North Am. 2012 Jun;39(2):255-68. doi: 10.1016/j.ogc.2012.04.001.
PubMed 22640714Zhang S, Gong TT, Liu FH, Jiang YT, Sun H, Ma XX, Zhao YH, Wu QJ. Global, Regional, and National Burden of Endometrial Cancer, 1990-2017: Results From the Global Burden of Disease Study, 2017. Front Oncol. 2019 Dec 19;9:1440. doi: 10.3389/fonc.2019.01440. eCollection 2019.
PubMed 31921687Fallon MT. Neuropathic pain in cancer. Br J Anaesth. 2013 Jul;111(1):105-11. doi: 10.1093/bja/aet208.
PubMed 23794652Oliveira KG, von Zeidler SV, Podesta JR, Sena A, Souza ED, Lenzi J, Bissoli NS, Gouvea SA. Influence of pain severity on the quality of life in patients with head and neck cancer before antineoplastic therapy. BMC Cancer. 2014 Jan 24;14:39. doi: 10.1186/1471-2407-14-39.
PubMed 24460780van den Beuken-van Everdingen MH, de Graeff A, Jongen JL, Dijkstra D, Mostovaya I, Vissers KC; national guideline working group "Diagnosis treatment of cancer pain". Pharmacological Treatment of Pain in Cancer Patients: The Role of Adjuvant Analgesics, a Systematic Review. Pain Pract. 2017 Mar;17(3):409-419. doi: 10.1111/papr.12459. Epub 2016 May 21.
PubMed 27207115Hochberg U, Minerbi A, Boucher LM, Perez J. Interventional Pain Management for Cancer Pain: An Analysis of Outcomes and Predictors of Clinical Response. Pain Physician. 2020 Sep;23(5):E451-E460.
PubMed 32967396
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management: A Randomized Controlled Trial of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT05427058
- Acronym / sponsor ID
- UB_WWN01
- Conditions
- Cervical Cancer, Endometrial Cancer
- Keywords
- Perineal Pain, Cervical Cancer, Endometrial Cancer, Superior Hypogastric Plexus Block, Ganglion Impar Block, pelvic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of BrawijayaUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| group 1: superior hypogastric plexus block group | Active comparator | Procedure: Superior Hypogastric Plexus BlockDevice: C-arm fluoroscopic device Drug: lidocaine + alcohol |
| group 2: ganglion impar block group | Experimental | Procedure: Ganglion Impar BlockDevice: C-arm fluoroscopic device Drug: lidocaine + alcohol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
- Loss to follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superior Hypogastric Plexus Blockthis 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. | Procedure or surgery | group 1: superior hypogastric plexus block group |
| Ganglion Impar Blockthis procedure uses a trans-sacrococcygeal approach by injecting 4 ml of 1% lidocaine + 6 ml of 96% alcohol and confirmed by C-arm. | Procedure or surgery | group 2: ganglion impar block group |
Primary outcome
Numerical rating scale (NRS)
Time frame: 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)
Time frame: 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)
Time frame: 3 Month
This is the dose that the patient takes regularly to relieve pain.
1 secondary outcome
Adverse effect
Time frame: 3 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Background: PubMed 28613745Fowler 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/
- Background: PubMed 22905480Vrachnis N, Iavazzo C, Salakos N, Papamargaritis E, Boutas I, Creatsas G. Uterine tamponade balloon for the management of massive hemorrhage during cesarean section due to placenta previa/increta. Clin Exp Obstet Gynecol. 2012;39(2):255-7.
- Background: PubMed 29929349Yoon SY, Oh J. Neuropathic cancer pain: prevalence, pathophysiology, and management. Korean J Intern Med. 2018 Nov;33(6):1058-1069. doi: 10.3904/kjim.2018.162. Epub 2018 Jun 25.
- Background: PubMed 20539035Schmidt BL, Hamamoto DT, Simone DA, Wilcox GL. Mechanism of cancer pain. Mol Interv. 2010 Jun;10(3):164-78. doi: 10.1124/mi.10.3.7.
- Background: PubMed 26009665Bhatnagar S, Gupta M. Evidence-based Clinical Practice Guidelines for Interventional Pain Management in Cancer Pain. Indian J Palliat Care. 2015 May-Aug;21(2):137-47. doi: 10.4103/0973-1075.156466.
- Background: PubMed 29276402Gunduz OH, Kenis-Coskun O. Ganglion blocks as a treatment of pain: current perspectives. J Pain Res. 2017 Dec 14;10:2815-2826. doi: 10.2147/JPR.S134775. eCollection 2017.
- Background: PubMed 196561Khan MA, Ashrafi SH, Decker SJ. The hepatic ultrastructure of chlordene-fed pigeons. Arch Environ Contam Toxicol. 1977;5(4):385-402. doi: 10.1007/BF02220919.
- Background: PubMed 32694387Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.
- Background: PubMed 25565862Tunio M, Al Asiri M, Bayoumi Y, Abdullah O Balbaid A, AlHameed M, Gabriela SL, Amir O Ali A. Lumbosacral plexus delineation, dose distribution, and its correlation with radiation-induced lumbosacral plexopathy in cervical cancer patients. Onco Targets Ther. 2014 Dec 23;8:21-7. doi: 10.2147/OTT.S71086. eCollection 2015.
- Background: PubMed 22640714Leslie KK, Thiel KW, Goodheart MJ, De Geest K, Jia Y, Yang S. Endometrial cancer. Obstet Gynecol Clin North Am. 2012 Jun;39(2):255-68. doi: 10.1016/j.ogc.2012.04.001.
- Background: PubMed 31921687Zhang S, Gong TT, Liu FH, Jiang YT, Sun H, Ma XX, Zhao YH, Wu QJ. Global, Regional, and National Burden of Endometrial Cancer, 1990-2017: Results From the Global Burden of Disease Study, 2017. Front Oncol. 2019 Dec 19;9:1440. doi: 10.3389/fonc.2019.01440. eCollection 2019.
- Background: PubMed 23794652Fallon MT. Neuropathic pain in cancer. Br J Anaesth. 2013 Jul;111(1):105-11. doi: 10.1093/bja/aet208.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ristiawan M Laksono principal investigator
Brawijaya University
Andika B Effendi study director
Brawijaya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superior Hypogastric Plexus Block and Ganglion Impar Block in people with Cervical Cancer and Endometrial Cancer, run by University of Brawijaya at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ristiawan M Laksono, MD,FIPP (+6281233773593, ristiawanm@ub.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (NRS) (time frame: 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05427058, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.