Clinical trial NCT05299047: Fluoroscopic Anterior Approach Versus Ultrasound Guided Superior Hypogastric Plexus Neurolysis in Cancer Pelvic Pain
Official title: Fluoroscopic Anterior Approach Versus Ultrasound Guided Superior Hypogastric Plexus Neurolysis in Cancer Pelvic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain Cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cancer related pelvic pain can be debilitating and difficult to treat. Superior hypogastric plexus neurolysis (SHPN) is considered to be an option for adequately relieving pain, with fewer side effects and improving the quality of life

Detailed description: The superior hypogastric plexus (SHP) is one of the paravertebral sympathetic ganglia, located in the lower border of the L5 vertebra and upper part of the sacrum in the retroperitoneal space. It is considered as a continuity of the celiac plexus and the lumbar sympathetic ganglia. It is related to the bifurcation of the aorta and the ureters. The SHP has a sympathetic connection (both efferent and afferent fibers) with splanchnic nerves and aortic plexus. It innervates the viscera of the pelvis, including the urinary bladder, ureters, sigmoid colon down to the anal canal, and upper vagina SHP blockade can be performed either by ultrasound (US), fluoroscopic, computed tomography (CT) and Magnetic resonance imaging (MRI) techniques and it is conducted through anterior (transabdominal) or posterior (lateral, paramedian, oblique, transdiscal, or transvaginal) approaches These different imaging modalities and approaches have been described for SHPN to make it easier, safer and more accurate and satisfied to the patients

Eligibility criteria: Inclusion Criteria:

* Patients more than 18 years old of both genders with cancer-related pelvic pain,
* poor pain control or severe side effects with opioid therapy,
* ≥ 4 on a numeric rating scale (NRS) of pain that ranged from 0 (no pain) to 10 (extreme pain).,
* American society of Anesthesiology Physical Status class I and II,
* positive diagnostic block day before the procedure by injecting a local anesthetic (0.25% bupivacaine 10 ml)
* Body mass index ˂ 30 were included in this study.

Exclusion Criteria:

* patient refusal,
* local or systemic sepsis,
* coagulopathy,
* unstable cardiovascular and respiratory diseases,
* previous neurological deficits,
* history of psychiatric disorders,
* history of drug abuse,
* distorted local anatomy,
* those who were allergic to the used medications were excluded from the study.

Primary outcomes:
measure: The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
timeFrame: 0ne hour before block
measure: The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
timeFrame: 1 month from block
measure: The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
timeFrame: 2 months from block
measure: The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
timeFrame: 3 months from block
Secondary outcomes:
measure: time of the procedures
timeFrame: intraoperative
measure: daily analgesic requirements
timeFrame: 3 months from injection
measure: patient satisfaction
timeFrame: 0ne month after block
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Yahya Wahba
Study officials:
References: