Fluoroscopic &Ultrasonographic Guidance of Superior Hypogastric Plexus Neurolysis in Intractable Pelvic Pain

The Role of Double Modality " Fluoroscopic &Ultrasonographic " Guidance of Superior Hypogastric Plexus Neurolysis in Treating Intractable Pelvic Cancer Pain: a Comparative Study.

fluoroscopic group & includes 30 patients where SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.the double modality group & includes 30 patients where SHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target position.

Study Overview

• Status: Completed
• Conditions: Intractable Pelvic Cancer Pain
• Intervention / Treatment: Procedure: fluroscopic guided block; Procedure: double modality (ultrasound and fluroscopic) guided block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • NCI, Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years.
• Intractable pelvic cancer pain (VAS > 40 mm)
• Pain is refractory to pharmacotherapy (both opioids and adjuvant therapy) or opioids' side effects are not tolerated.

Exclusion criteria

• Local or systemic sepsis.
• Uncorrectable coagulopathy.
• Neuropsychiatric illness.
• History of drug abuse.
• Pregnant or lactating patients.
• Distorted local anatomy.
• Patients who are known to be allergic to the used medications.
• Cardiovascular or respiratory instability.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fluroscopic guided block	Procedure: fluroscopic guided block; SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.
Experimental: double modality guided block	Procedure: double modality (ultrasound and fluroscopic) guided block; SHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target position. Then C-arm pictures will be checked (both P-A & dead lateral)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain relief will be assessed by VAS	pain relief will be assessed by VAS (visual Analogue score) which is 100 mscale with left (0) end means no pain & right (10) end means the worst possible pain	12 weeks

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 15, 2019

Study Registration Dates

• First Submitted: July 14, 2018
• First Submitted That Met QC Criteria: July 28, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 11, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Pelvic Neoplasms; Cancer Pain
• Other Study ID Numbers: IORG0003301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No