Ultrasound Versus Fluoroscopy Guided Superior Hypogastric Plexus Block in Cancer Bladder Patients

Not Applicable

• Conditions: Pain, Chronic
• Interventions: Procedure: Fluoroscopy-guided superior hypogastric plexus block transdiscal approach; Procedure: ultrasound-guided superior hypogastric plexus block

• Registration Number: NCT05083702
• Lead Sponsor: National Cancer Institute, Egypt

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)

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-06-10
• Primary Completion: 2021-09-30
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-18
• Last Update Submitted: 2021-10-18
• Study First Posted: 2021-10-19
• Last Update Posted: 2021-10-19
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoroscopy-guided superior hypogastric plexus block transdiscal approach	Fluoroscopy-guided superior hypogastric plexus block transdiscal approach	fluroscopy guided superior hypogastric plexus block transdiscal approach for chronic pain treatment in cancer bladder VAS score and morphine consumption are measured before and after 1 day , 1 month , 3 monthes
ultrasound-guided superior hypogastric plexus block	ultrasound-guided superior hypogastric plexus block	ultrasound guided superior hypogastric plexus block in treatment of chronic pain in cancer badder VAS score and morphine consumption are measured before and after 1 day , 1 month , 3 monthes

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) score	Three months after the procedure	Pain Intensity measured by Visual analogue scale score16 (A 100 mm horizontal line version is used with 2 ends left end means no pain and right end means the worst pain.; VAS will be recorded before and after the procedure, at the first day, after 1 month and after 3 months.

Secondary Outcome Measures

Name	Time	Method
The amount of daily morphine consumption	Three months after the procedure	Daily morphine or other drugs consumption according to WHO ladder after the procedure.; This will be recorded before and after the procedure, at the first day, after 1 month and after 3 months.
Patient functional capacity	Three months after the procedure	Patient functional capacity (is evaluated using Eastern cooperative oncology group "ECOG" scoring (0=fully active, 1= able to perform light effort, 2= in bed \<50% of the day 3=in bed \>50% of the day, 4=bed ridden).; This will be recorded before and after the procedure, at the first day, after 1 month and after 3 months.
Quality of life	Three months after the procedure	Patient quality of life SF-36 19 (consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.; This will be recorded before and after the procedure, at the first day, after 1 month and after 3 months.
Complications	Three months after the procedure	Any complications will be detected: back pain, bleeding, infection, L5 root injury with paresthesia or motor weakness, and visceral or vascular injuries.

Trial Locations

Locations (1)

National cancer institute; 🇪🇬 Cairo, Egypt