Clinical trial NCT05083702: Ultrasound Versus Fluoroscopy Guided Superior Hypogastric Plexus Block in Cancer Bladder Patients
Official title: Ultrasound Versus Fluoroscopic Guided Superior Hypogastric Plexus Block in Cancer Bladder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Chronic
Keywords: fluroscopy and ultrasound SHPB in cancer bladder
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Pelvic cancer pain is a chronic condition related to the involvement of viscera, pelvic muscular structures or neural structures by tumor. The superior hypogastric plexus block is a sympathetic block used to treat pelvic visceral pain that is unresponsive to oral or parenteral opioids different approaches for superior hypogastric block as transdiscal approach, classic approach, Posteromedial approach, CT guided approach and ultrasound anterior approach The ultrasound-guided superior hypogastric plexus neurolysis technique (anterior approach) is simple to perform. We believe this block can be useful in cancer patients who are having difficulty in lying prone, because it is a procedure performed in the supine position and it is less time-consuming. It also avoids the radiation exposure involved with a computed tomography-guided and fluoroscopy posterior approach.

Detailed description: Aim of the study:

To compare Fluoroscopic guided transdiscal superior hypogastric block and Ultrasound guided superior hypogastric block regarding their efficacy to control pelvic pain and

Statistical analysis:

Data will be described as mean ±SD or as frequencies (number of cases) and percentages when appropriate. Comparison of numerical variables between two study groups will be carried out using parametric and non-parametric t- tests for independent samples. Within group comparison of numerical variables was carried out using repeated measures ANOVA. P values of less than 0.05 will be statistically significant. All statistical calculations are performed using statistical package for the social sciences (SPSS, version 23 for Microsoft Windows; SPSS Inc., Chicago, Illinois, USA)

Eligibility criteria: Inclusion Criteria:

* Age \> 20 years.
* Patients with advanced stage cancer bladder.
* Patient with severe pain (VAS) 7 or more .
* Patients don't receive any strong opioids for pain at least 2 weeks

Exclusion Criteria:

* Patient refusal.
* Local infection at the puncture site.
* Coagulopathy.
* Cognitive disorders.
* Unstable cardiovascular disease.
* History of psychiatric disorders.
* History of drug abuse.
* Patients allergic to medication used.
* Patients with any contraindications to drugs and dye used.

Primary outcomes:
measure: Visual analogue scale (VAS) score
timeFrame: Three months after the procedure
Secondary outcomes:
measure: The amount of daily morphine consumption
timeFrame: Three months after the procedure
measure: Patient functional capacity
timeFrame: Three months after the procedure
measure: Quality of life
timeFrame: Three months after the procedure
measure: Complications
timeFrame: Three months after the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National cancer institute
Study officials:
affiliation: National Cancer Institute (NCI)
name: Khaled Mostafa
role: STUDY_DIRECTOR
References: