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Active, not recruitingNCT06719635Updated May 6, 2026

Management Modalities of Chronic Pelvic Pain

An interventional study of Laparoscopic Presacral Neurectomy and Fluoroscopically guided Superior Hypogastric Plexus Neurolysis in Pain, Chronic, sponsored by Zagazig University. Active, not recruiting at 1 site in Egypt. Open to female participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Pain, Chronic

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In context

Chronic Pain

2,928 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.

This study's enrollment of 62 is close to the median of 60 across 2,160 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Uncooperative patient.
  • Patients with coagulopathy, infection at the site of injection, severe cardiac compromise, or intolerance to sympathetic block.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    Laparoscopic Presacral Neurectomy

    The patients will undergo Laparoscopic Presacral Neurectomy under general anesthesia.

    Procedure: Laparoscopic Presacral Neurectomy

  • Active comparator
    Fluoroscopically guided Superior Hypogastric Neurolysis

    The patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis with Radiofrequency of the Sacral Roots 2,3,4.

    Procedure: Fluoroscopically guided Superior Hypogastric Plexus Neurolysis

Interventions

  • ProcedureLaparoscopic Presacral Neurectomy

    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.

  • ProcedureFluoroscopically guided Superior Hypogastric Plexus Neurolysis

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the end of the first month after the procedure.

Secondary outcomes

  1. 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.

    Time frame: At the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.

  2. Associated adverse events

    Any related adverse events "e.g. hypotension, bleeding or neurological deficits" in the first month after the procedure.

    Time frame: At the end of the first month after the procedure.

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Study locations

1 site
  • Zagazig university hospital
    Zagazig, Al-Sharkia 44519, Egypt
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References and documents

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 8233527 ↗
  • Ghai 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 32654406 ↗
  • Hetta 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 32214294 ↗
  • Soysal 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06719635
Lead sponsor
Zagazig University
Responsible party
Sponsor
First posted
Dec 6, 2024
Start date
Dec 7, 2024
Primary completion
Oct 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 6, 2026

Study contacts

Abdalla Mohamed Gouda, MD
principal investigator · Department of Anesthesia, Intensive Care & Pain Management, Zagazig University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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