Pre-emptive US Guided Superior Hypogastric Plexus Block i... | NCT04732234

Studies
Pre-emptive US Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study

NCT04732234

Sponsor

National Cancer Institute, Egypt

Status

Unknown status

Last Update Posted

Feb 1, 2021Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Analgesia

Interventions

Superior Hypogastric Plexus 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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

May 2021Estimated

Completion Date

May 2021Estimated

First Submitted Date

Dec 25, 2020

First Submission Date that Met QC Criteria

Jan 26, 2021

First Posted Date

Feb 1, 2021Actual

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 26, 2021

Last Update Posted Date

Feb 1, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammed Abdelfattah Abdelwadod, Mohammed Abdelfattah Abdelwadod, National Cancer Institute, EgyptPrincipal Investigator

Lead Sponsor

National Cancer Institute, EgyptOTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The superior hypogastric plexus (SHP) is a retroperitoneal structure with a predominance of afferent sympathetic nerve fibers. The perception of central pelvic pain is thought mainly to involve transmission through this plexus. Therefore, blocking or of SHP has been used to treat pelvic pain.

Detailed Description

Ultrasound guided superior hypogastric plexus block there is 2 equal groups:

Group S (SHPB group 18 patients) ultrasound guided SHPB is done after induction of balanced general anesthesia (fentanyl, propofol and rocuronium) using 20 ml Bupivacaine 0.5% before skin incision, Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9% instead of bupivacaine. Patients of both groups will receive patient controlled analgesia using morphine with continous background infusion of morphine 1.5 mg/h with adding granisterone 2mg/60 ml and ability to give bolus of 0.5 mg morphine on demand.

• Dosing and administration; Group S (SHPB group 18 ultrasound guided SHPB ) using 20 ml Bupivacaine 0.5% before skin incision.

Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9%

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
( Group A)	Active Comparator	ultrasound guided superior hypogastric plexus block using 20 ml Bupivacaine 0.5% before skin incision.	Procedure: Superior Hypogastric Plexus Block
(Group B)	Placebo Comparator	ultrasound guided superior hypogastric plexus block using 20 ml normal saline 0.9% instead of bupivacaine.	Procedure: Superior Hypogastric Plexus Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Superior Hypogastric Plexus Block	Procedure	Pre operative ultrasound guided superior hypogastric plexus block in pelvic surgeries using a curvilinear probe below umbalicus with needle in plane technique to reach the plexus in front of L5 vertebra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
morphine consumption	Total 24 hours morphine consumption in milligrams	baseline till 24 hours postoperative

Secondary Outcomes

Measure	Description	Time Frame
Visual analogue scale (VAS)	scale in which 0 is least pain and 10 is sever pain	Visual analogue scale (VAS) at baseline till 24 hours postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA II,III.
Patients undergoing pelvic surgeries.

Exclusion Criteria:

Patients refusal,
Coagulopathy,
Infection.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamed abdel wadod, MD	Anesthesia & pain management Dept, National Cancer Institute-Cairo - Egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nataional Cancer Instituite		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Group S (SHPB group 18 ultrasound guided SHPB ) using 20 ml Bupivacaine 0.5% before skin incision.

Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9%