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

N

National Cancer Institute, Egypt

Status

Unknown

Conditions

Pain, Chronic

Treatments

Procedure: Fluoroscopy-guided superior hypogastric plexus block transdiscal approach
Procedure: ultrasound-guided superior hypogastric plexus block

Study type

Interventional

Funder types

Other

Identifiers

NCT05083702
AP2103-30101R

Details and patient eligibility

About

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.

Full 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)

Enrollment

60 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Fluoroscopy-guided superior hypogastric plexus block transdiscal approach
Active Comparator group
Description:
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
Treatment:
Procedure: Fluoroscopy-guided superior hypogastric plexus block transdiscal approach
ultrasound-guided superior hypogastric plexus block
Active Comparator group
Description:
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
Treatment:
Procedure: ultrasound-guided superior hypogastric plexus block

Trial contacts and locations

1

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Central trial contact

Khaled Mostafa, Professor; Asmaa khalil, A.lecturer

Data sourced from clinicaltrials.gov

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