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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Rhomboid Intercostal Block
• Intervention / Treatment: Drug: Rhomboid Intercostal and Sub-Serratus block

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control group; patients will receive sham block.	Drug: Rhomboid Intercostal and Sub-Serratus block; Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance
Active Comparator: RISS group; will receive Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance	Drug: Rhomboid Intercostal and Sub-Serratus block; Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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;	24 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 21, 2022
• Primary Completion (Anticipated): August 13, 2023
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: March 19, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: N-74-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: still working

Drug and device information, study documents

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