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

NCT05083702 | Unknown DMC

• 1 other identifier: AP2103-30101R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Keywords

fluroscopy and ultrasound SHPB in cancer bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Arms (2)

Fluoroscopy-guided superior hypogastric plexus block transdiscal approach

ACTIVE COMPARATOR

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

ultrasound-guided superior hypogastric plexus block

ACTIVE COMPARATOR

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

Interventions

Fluoroscopy-guided superior hypogastric plexus block transdiscal approach PROCEDURE

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.

Also known as: fluroscopy

Fluoroscopy-guided superior hypogastric plexus block transdiscal approach

ultrasound-guided superior hypogastric plexus block PROCEDURE

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

Also known as: ultrasound

ultrasound-guided superior hypogastric plexus block

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National cancer institute

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Khaled Mostafa

  National Cancer Institute (NCI)

  STUDY DIRECTOR

Central Study Contacts

Asmaa khalil, A.lecturer

CONTACT

01009468049; sosoelsayed1177@yahoo.com

Khaled Mostafa, Professor

CONTACT

01011505033; K24mostafa@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: October 19, 2021
• Study Start: December 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

EG (1)