Rhomboid Intercostal and Subserratus Plane (RISS) Block o... | NCT05301075

Studies
Rhomboid Intercostal and Subserratus Plane (RISS) Block on Postoperative Painafter Open Nephrectomy Surgery

NCT05301075

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Mar 29, 2022Actual

Enrollment

60Estimated

Phase

Early Phase 1

Conditions

Rhomboid Intercostal Block

Interventions

Rhomboid Intercostal and Sub-Serratus 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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 21, 2022Estimated

Primary Completion Date

Aug 13, 2023Estimated

Completion Date

Aug 30, 2023Estimated

First Submitted Date

Mar 19, 2022

First Submission Date that Met QC Criteria

Mar 19, 2022

First Posted Date

Mar 29, 2022Actual

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

Mar 19, 2022

Last Update Posted Date

Mar 29, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amr Samir Wahdan, Lecturer of Anesthesia, Pain management and Surgical ICU, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Rhomboid intercostal block (RIB) is a new interfascial plane block describe by Elsharkawy et al. in 2016. The region described is understood because the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. In this ultrasound-guided block, the local anaesthetic drug is run between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Sham Comparator	patients will receive sham block.	Drug: Rhomboid Intercostal and Sub-Serratus block
RISS group	Active Comparator	will receive Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance	Drug: Rhomboid Intercostal and Sub-Serratus block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rhomboid Intercostal and Sub-Serratus block	Drug	Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance	RISS group control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
nalbuphine consumption i	Postoperative nalbuphine consumption	24 hours

Secondary Outcomes

Measure	Description	Time Frame
nalbuphine consumption.	intraoperative nalbuphine consumption.	2 hours
Patient's satisfaction	using 1-4 scales (1, bad; 2, moderate; 3, good; 4, excellent;

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria Adult patients between 18-60 years. Genders eligible for study: both sexes ASA physical status I and II Undergoing open nephrectomy surgery
Exclusion criteria Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding disorders Use of any anti-coagulants Inability to provide informed consent ASA III-IV

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo university		Cairo		11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

still working

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided