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

Primary Purpose

Intractable Pelvic Cancer Pain

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

fluroscopic guided block

double modality (ultrasound and fluroscopic) guided block

About this trial

This is an interventional supportive care trial for Intractable Pelvic Cancer Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

NCI, Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

fluroscopic guided block

double modality guided block

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03606811

First Posted

July 14, 2018

Last Updated

January 11, 2020

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03606811

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

August 5, 2018 (Actual)

Primary Completion Date

August 1, 2019 (Actual)

Study Completion Date

August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intractable Pelvic Cancer Pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fluroscopic guided block

Arm Type

Active Comparator

Arm Title

double modality guided block

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

fluroscopic guided block

Intervention Description

SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.

Intervention Type

Procedure

Intervention Name(s)

double modality (ultrasound and fluroscopic) guided block

Intervention Description

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)

Primary Outcome Measure Information:

Title

pain relief will be assessed by VAS

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

NCI, Cairo university

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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