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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Procedure: Fluoroscopy-guided superior hypogastric plexus block transdiscal approach; Procedure: ultrasound-guided superior hypogastric plexus block

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asmaa khalil, A.lecturer; Phone Number: 01009468049; Email: sosoelsayed1177@yahoo.com
• Study Contact Backup: Name: Khaled Mostafa, Professor; Phone Number: 01011505033; Email: K24mostafa@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • National Cancer Institute
    • Contact: Asmaa Khalil, A.lecturer; Phone Number: 01009468049; Email: sosoelsayed11@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Procedure: Fluoroscopy-guided superior hypogastric plexus block transdiscal approach; 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.; Other Names: fluroscopy
ACTIVE_COMPARATOR: 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	Procedure: ultrasound-guided superior hypogastric plexus block; 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; Other Names: ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three months after the procedure
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.	Three months after the procedure
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.	Three months after the procedure
Complications	Any complications will be detected: back pain, bleeding, infection, L5 root injury with paresthesia or motor weakness, and visceral or vascular injuries.	Three months after the procedure

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Study Director: Khaled Mostafa, National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ANTICIPATED): October 30, 2021

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (ACTUAL): October 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: fluroscopy and ultrasound SHPB in cancer bladder
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: AP2103-30101R

Drug and device information, study documents

• 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