Pain, ChronicNCT06719635
Management Modalities of Chronic Pelvic Pain
A study testing Laparoscopic Presacral Neurectomy and Fluoroscopically guided Superior Hypogastric Plexus Neurolysis in people with Pain, Chronic, run by Zagazig University at 1 site in Egypt.
Trial summary
Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Laparoscopic Presacral Neurectomy and Fluoroscopically guided Superior Hypogastric Plexus Neurolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Dec 2024to Dec 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient acceptance.
- Body mass index < 35 kg/m2.
- Adult patients with chronic pelvic and perineal pain due to pelvic cancer.
- Visual Analog Scale pain score ≥ 5 on a 0-10 scale despite treatment with a standard analgesic.
Who cannot join
- Uncooperative patient.
- Patients with coagulopathy, infection at the site of injection, severe cardiac compromise, or intolerance to sympathetic block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Presacral Neurectomy Versus Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis for Treatment of Chronic Pelvic Pain: A Double-Blind, Randomized Controlled Trial.
Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women.
Read the detailed description
Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women. The current study will investigate whether Laparoscopic Presacral Neurectomy or Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis is more effective for treating chronic pelvic pain.
- Conditions
- Pain, Chronic
- Being tested
- Laparoscopic Presacral Neurectomy, Fluoroscopically guided Superior Hypogastric Plexus Neurolysis
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Presacral NeurectomyProcedure or surgery
Laparoscopy will be performed under general anesthesia. Then, nerve plexuses will be identified and freed from their underlying tissue, which contains the left common iliac and middle sacral veins. This will be followed by cauterization and cutting of the nerve plexuses.
Fluoroscopically guided Superior Hypogastric Plexus NeurolysisProcedure or surgery
The patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis using 3 mL of 75% ethanol and Radiofrequency of the Sacral nerve Roots 2-4.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Presacral Neurectomy | Active comparator | The patients will undergo Laparoscopic Presacral Neurectomy under general anesthesia. Receives: Procedure: Laparoscopic Presacral Neurectomy |
| Fluoroscopically guided Superior Hypogastric Neurolysis | Active comparator | The patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis with Radiofrequency of the Sacral Roots 2,3,4. Receives: Procedure: Fluoroscopically guided Superior Hypogastric Plexus Neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain score
The percentage of patients who achieved > 50% decline in their Visual analogue pain score "from the baseline value" before intervention at the end of the first month.
Measured: At the end of the first month after the procedure.
Secondary outcomes (2)
Daily analgesic requirements
Daily analgesic requirements at the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.
Measured: At the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.
Associated adverse events
Any related adverse events "e.g. hypotension, bleeding or neurological deficits" in the first month after the procedure.
Measured: At the end of the first month after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start7 Dec 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Abdalla Mohamed Gouda, MD, Principal investigator, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719635
- Sponsor's protocol ID
- Pelvic Pain Management
- Status last verified
- Nov 2025
- First submitted
- 2 Dec 2024
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Leon-Casasola OA, Kent E, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Pain. 1993 Aug;54(2):145-151. doi: 10.1016/0304-3959(93)90202-Z.
PubMed 8233527Ghai V, Subramanian V, Jan H, Pergialiotis V, Thakar R, Doumouchtsis SK; CHORUS: An International Collaboration for Harmonising Outcomes, Research, Standards in Urogynaecology, Women's Health. A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set. BJOG. 2021 Mar;128(4):628-634. doi: 10.1111/1471-0528.16412. Epub 2020 Sep 1.
PubMed 32654406Hetta DF, Mohamed AA, Abdel Eman RM, Abd El Aal FA, Helal ME. Pulsed Radiofrequency of the Sacral Roots Improves the Success Rate of Superior Hypogastric Plexus Neurolysis in Controlling Pelvic and Perineal Cancer Pain. Pain Physician. 2020 Mar;23(2):149-157.
PubMed 32214294Soysal ME, Soysal S, Gurses E, Ozer S. Laparoscopic presacral neurolysis for endometriosis-related pelvic pain. Hum Reprod. 2003 Mar;18(3):588-92. doi: 10.1093/humrep/deg127.
PubMed 12615830
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Presacral Neurectomy Versus Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis for Treatment of Chronic Pelvic Pain: A Double-Blind, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06719635
- Acronym / sponsor ID
- Pelvic Pain Management
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 7 Dec 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Dec 2024 (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.
Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women.
Detailed description
Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women. The current study will investigate whether Laparoscopic Presacral Neurectomy or Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis is more effective for treating chronic pelvic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Presacral Neurectomy | Active comparator | Procedure: Laparoscopic Presacral NeurectomyThe patients will undergo Laparoscopic Presacral Neurectomy under general anesthesia. |
| Fluoroscopically guided Superior Hypogastric Neurolysis | Active comparator | Procedure: Fluoroscopically guided Superior Hypogastric Plexus NeurolysisThe patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis with Radiofrequency of the Sacral Roots 2,3,4. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient acceptance.
- Body mass index < 35 kg/m2.
- Adult patients with chronic pelvic and perineal pain due to pelvic cancer.
- Visual Analog Scale pain score ≥ 5 on a 0-10 scale despite treatment with a standard analgesic.
Key exclusion criteria (2 listed)
- Uncooperative patient.
- Patients with coagulopathy, infection at the site of injection, severe cardiac compromise, or intolerance to sympathetic block.
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 |
|---|---|---|
| Laparoscopic Presacral NeurectomyLaparoscopy will be performed under general anesthesia. Then, nerve plexuses will be identified and freed from their underlying tissue, which contains the left common iliac and middle sacral veins. This will be followed by cauterization and cutting of the nerve plexuses. | Procedure or surgery | Laparoscopic Presacral Neurectomy |
| Fluoroscopically guided Superior Hypogastric Plexus NeurolysisThe patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis using 3 mL of 75% ethanol and Radiofrequency of the Sacral nerve Roots 2-4. | Procedure or surgery | Fluoroscopically guided Superior Hypogastric Neurolysis |
Primary outcome
Visual analogue pain score
Time frame: At the end of the first month after the procedure.
The percentage of patients who achieved > 50% decline in their Visual analogue pain score "from the baseline value" before intervention at the end of the first month.
2 secondary outcomes
Daily analgesic requirements
Time frame: At the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.
Associated adverse events
Time frame: At the end of the first month after the procedure.
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 6 May 2026.
- Background: PubMed 8233527de Leon-Casasola OA, Kent E, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Pain. 1993 Aug;54(2):145-151. doi: 10.1016/0304-3959(93)90202-Z.
- Background: PubMed 32654406Ghai V, Subramanian V, Jan H, Pergialiotis V, Thakar R, Doumouchtsis SK; CHORUS: An International Collaboration for Harmonising Outcomes, Research, Standards in Urogynaecology, Women's Health. A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set. BJOG. 2021 Mar;128(4):628-634. doi: 10.1111/1471-0528.16412. Epub 2020 Sep 1.
- Background: PubMed 32214294Hetta DF, Mohamed AA, Abdel Eman RM, Abd El Aal FA, Helal ME. Pulsed Radiofrequency of the Sacral Roots Improves the Success Rate of Superior Hypogastric Plexus Neurolysis in Controlling Pelvic and Perineal Cancer Pain. Pain Physician. 2020 Mar;23(2):149-157.
- Background: PubMed 12615830Soysal ME, Soysal S, Gurses E, Ozer S. Laparoscopic presacral neurolysis for endometriosis-related pelvic pain. Hum Reprod. 2003 Mar;18(3):588-92. doi: 10.1093/humrep/deg127.
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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. This study is not recruiting at the moment.
Abdalla Mohamed Gouda, MD principal investigator
Department of Anesthesia, Intensive Care & Pain Management, Zagazig 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 Laparoscopic Presacral Neurectomy and Fluoroscopically guided Superior Hypogastric Plexus Neurolysis in people with Pain, Chronic, run by Zagazig University at 1 site in Egypt.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue pain score (time frame: At the end of the first month after the procedure.). 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 NCT06719635, which also lists 4 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 6 May 2026.