Clinical trial NCT06719635: Management Modalities of Chronic Pelvic Pain
Official title: Laparoscopic Presacral Neurectomy Versus Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis for Treatment of Chronic Pelvic Pain: a Double-Blind, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-12-06
Enrollment: 62
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Visual analogue pain score
timeFrame: At the end of the first month after the procedure.
Secondary outcomes:
measure: Daily analgesic requirements
timeFrame: At the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.
measure: Associated adverse events
timeFrame: At the end of the first month after the procedure.
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university hospital
state: Al-Sharkia
Study officials:
affiliation: Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
name: Abdalla Mohamed Gouda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.