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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Presacral Neurectomy | Active Comparator | The patients will undergo Laparoscopic Presacral Neurectomy under general anesthesia. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Presacral Neurectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of the first month after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure. |
| Associated adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdalla Mohamed Gouda, MD | Department of Anesthesia, Intensive Care & Pain Management, Zagazig University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig university hospital | Zagazig | Al-Sharkia | 44519 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8233527 | Background | 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. | |
| 32654406 | Background | 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. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Fluoroscopically guided Superior Hypogastric Plexus Neurolysis | Procedure | 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. |
|
Any related adverse events "e.g. hypotension, bleeding or neurological deficits" in the first month after the procedure. |
| At the end of the first month after the procedure. |
| 32214294 | Background | 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. |
| 12615830 | Background | 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. |