Fluoroscopic &Ultrasonographic Guidance of Superior Hypog... | NCT03606811

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

NCT03606811

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jan 14, 2020Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Intractable Pelvic Cancer Pain

Interventions

fluroscopic guided block
double modality (ultrasound and fluroscopic) guided block

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2018Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Aug 15, 2019Actual

First Submitted Date

Jul 14, 2018

First Submission Date that Met QC Criteria

Jul 28, 2018

First Posted Date

Jul 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2020

Last Update Posted Date

Jan 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed H Othman, Assisstant professor of Anesthesia ICU and pain Relief, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fluroscopic guided block	Active Comparator		Procedure: fluroscopic guided block
double modality guided block	Experimental		Procedure: double modality (ultrasound and fluroscopic) guided block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fluroscopic guided block	Procedure	SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.	fluroscopic guided block

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

Browse Leaves

Not provided

Browse Branches

Not provided