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

Primary Purpose

Pain, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fluoroscopy-guided superior hypogastric plexus block transdiscal approach
ultrasound-guided superior hypogastric plexus block
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Chronic focused on measuring fluroscopy and ultrasound SHPB in cancer bladder

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • National cancer instituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fluoroscopy-guided superior hypogastric plexus block transdiscal approach

ultrasound-guided superior hypogastric plexus block

Arm 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

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

Outcomes

Primary Outcome Measures

Visual analogue scale (VAS) score
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

The amount of daily morphine consumption
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
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
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
Any complications will be detected: back pain, bleeding, infection, L5 root injury with paresthesia or motor weakness, and visceral or vascular injuries.

Full Information

First Posted
June 10, 2021
Last Updated
October 18, 2021
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05083702
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
fluroscopy and ultrasound SHPB in cancer bladder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluoroscopy-guided superior hypogastric plexus block transdiscal approach
Arm Type
Active Comparator
Arm 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
Arm Title
ultrasound-guided superior hypogastric plexus block
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Fluoroscopy-guided superior hypogastric plexus block transdiscal approach
Other Intervention Name(s)
fluroscopy
Intervention Description
Patient lies prone, L5-S1 interspace identified under fluoroscopy, the skin is prepared and sterile drapes are placed after local anesthetic infiltration of the skin the subcutaneous tissue with 2% lidocaine a 20 guage, 15 cm needle with short bevel is inserted at the center of L5- S1 interlaminar space under anteroposterior fluoroscopic vision. The needle is then advanced toward the intervertebral disc. After confirmation, the needle is advanced through the intervertebral disc until it exists at its anterior surface confirmed by administration of 4 ml of soluble contrast media in both lateral and anteroposterior fluoroscopic view. Neurolysis is performed with 8 ml 8 % phenol solution. After neurolysis, 0.5 ml of saline is given to avoid the deposition of phenol within the intervertebral disc material. While withdrawing, the needle cephazoline 50 mg in 1 ml is injected into the disc.
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided superior hypogastric plexus block
Other Intervention Name(s)
ultrasound
Intervention Description
Patients are placed in the supine position and after sterilization, the low-frequency curved probe is used in the longitudinal axis to visualize the aortic bifurcation and is identified using a longitudinal Ultra-Sound (Phillips Healthcare, Andover, Massachusetts, US). Next, the probe is placed deeply transverse till aorta end and bifurcation seen of iliac vessels once seen we enter out of plane and inject.as it lies in front the vertebral body of the L5 vertebra. Local infiltration with 1% lidocaine is obtained at port of entry 1-1.5 inches below the umbilicus. A 15-cm, 22-G Chiba needle is inserted (out-of-plane) and advanced by avoiding vascular structures until contact with the L5-body. The needle will be withdrawan the 1-2 mm and inject 8 ml 8% phenol in saline. Finally, 0.5 ml of lidocaine is injected during Chiba needle removal
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS) score
Description
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.
Time Frame
Three months after the procedure
Secondary Outcome Measure Information:
Title
The amount of daily morphine consumption
Description
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.
Time Frame
Three months after the procedure
Title
Patient functional capacity
Description
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.
Time Frame
Three months after the procedure
Title
Quality of life
Description
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.
Time Frame
Three months after the procedure
Title
Complications
Description
Any complications will be detected: back pain, bleeding, infection, L5 root injury with paresthesia or motor weakness, and visceral or vascular injuries.
Time Frame
Three months after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asmaa khalil, A.lecturer
Phone
01009468049
Email
sosoelsayed1177@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled Mostafa, Professor
Phone
01011505033
Email
K24mostafa@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Mostafa
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Director
Facility Information:
Facility Name
National cancer institute
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa Khalil, A.lecturer
Phone
01009468049
Email
sosoelsayed11@yahoo.com

12. IPD Sharing Statement

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

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