Skip to main content
Clinical Trials/NCT05083702
NCT05083702
Unknown
Not Applicable

Ultrasound Versus Fluoroscopic Guided Superior Hypogastric Plexus Block in Cancer Bladder: A Randomized Controlled Trial

National Cancer Institute, Egypt1 site in 1 country60 target enrollmentDecember 1, 2020
ConditionsPain, Chronic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Chronic
Sponsor
National Cancer Institute, Egypt
Enrollment
60
Locations
1
Primary Endpoint
Visual analogue scale (VAS) score
Last Updated
4 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
October 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Cancer Institute, Egypt
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Visual analogue scale (VAS) score

Time Frame: 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 Outcomes

  • The amount of daily morphine consumption(Three months after the procedure)
  • Patient functional capacity(Three months after the procedure)
  • Quality of life(Three months after the procedure)
  • Complications(Three months after the procedure)

Study Sites (1)

Loading locations...

Similar Trials