Ultrasound Guided Rhomboid Intercostal Subserratus Plane Block vs Erector Spinae Plane Block in Open Nephrectomy

May 16, 2025 updated by: Ahmed Mahmoud Saad, Cairo University

Ultrasound Guided Rhomboid Intercostal Subserratus Plane Block Versus Erector Spinae Plane Block in Open Nephrectomy. Randomized Controlled Study

Our aim is to measure the efficacy of rhomboid intercostal subserratus plane block and erector spinae plane block in patients undergoing open nephrectomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open nephrectomy incision is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery. Regional anesthesia techniques are commonly recommended for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction. Rhomboid intercostal subserratus plane block (RISS) is considered a novel approach for chest wall and upper abdominal analgesia, initially showed promising results, first reported in 2016. Erector Spinae Plane block (ESB), was initially described in 2016 for analgesia in thoracic neuropathic pain. It has also been widely used in both adults and children at different levels for different indications. Epidural analgesia is the gold standard for perioperative analgesia in open surgery.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Type of surgery; open nephrectomy.
  2. Physical status ASA II, III.
  3. Body mass index (BMI): > 20 kg/ m2 and < 35 kg/ m2.

Exclusion Criteria:

  1. Patient refusal.
  2. Local infection at the puncture site.
  3. Severe respiratory or cardiac disorders.
  4. Advanced liver or kidney disease.
  5. History of psychological disorders and/or chronic pain.
  6. Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
  7. Patients with known sensitivity or contraindication to amide local anesthetics used in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector spinae block
Under strict aseptic precautions, we will begin the scout scan with a high-frequency (6-12 MHz) linear US probe placed parasagitally in cephalocaudal orientation adjacent to C7 spinous process and the first rib will be identified with ultrasound. Then, we can directly count the ribs and come down to desired level of ribs or corresponding transverse process (the 8th thoracic spinous process). Once located, erector spinae and trapezius muscles will be identified overlying it. The skin will be infiltrated by 2 ml of lidocaine 1% subcutaneously and a 22- gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be advanced in plane in the cranio-caudal direction. When the needle contacted the transverse process, 1 ml normal saline will be injected to confirm correct needle placement by visualizing the linear pattern of hydrodissection. After aspiration, 30 ml bupivacaine 0.25% will be injected.
Procedure: Erector spinae plane block
Fascial plane block
Other Names:
  • ESB
Active Comparator: Rhomboid intercostal block
While the patient in the sitting position, the 5th thoracic spinous process can be identified, a high-frequency (6-12 MHz) linear US probe will be placed in the sagittal plane medial to the medial border of the scapula and then rotated to be 1 to 2 cm medial to the medial scapular border. The plane between the rhomboid major and the intercostal muscles will be identified. 2 ml of lidocaine 1% subcutaneously and a 22- gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be advanced in plane from a superomedial to an inferolateral direction then 15 ml of bupivacaine 0.25% will be administered (at the T5 level). Then the probe will be moved caudally and laterally to identify the tissue plane between the serratus anterior and the external intercostal muscle at the T8 level. The needle will be directed caudally and laterally beyond the inferior angle of the scapula. 15 ml of bupivacaine 0.25% will be administered.
Procedure: Rhomboid intercostal subserratus plane block
Fascial plane block
Other Names:
  • RISS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total amount of morphine consumption in (mg)
Time Frame: first 24 hours postoperatively.
amount of morphine in mg consumed in 1st 24 hours
first 24 hours postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of first request of analgesia
Time Frame: first 24 hours postoperatively
calculated from the time of complete injection of local anesthetics till the numerical pain rating scale (NRS) is ≥3.(NRS requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable)
first 24 hours postoperatively
Total amount fentanyl in (microgram)
Time Frame: intra operative duration
total amount of intraoperative fentanyl consumed in micrograms
intra operative duration
Change in heart rate in (beat/min)
Time Frame: From just before induction till 24 hours post operatively
Readings will be taken as baseline preoperative reading, immediately after surgical incision and at 15-minute intervals intraoperatively and 30 minutes,2,4,8,12,16 and 24 hours postoperatively
From just before induction till 24 hours post operatively
Change in mean arterial blood pressure in (mmHg)
Time Frame: From just before induction till 24 hours post operatively
Readings will be taken as baseline preoperative reading, immediately after surgical incision and at 15-minute intervals intraoperatively and 30 minutes,2,4,8,12,16 and 24 hours postoperatively
From just before induction till 24 hours post operatively
Numeric Pain Rating Scale
Time Frame: first 24 hours postoperatively
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
first 24 hours postoperatively
Nausea and vomiting Scores
Time Frame: first 24 hours postoperatively
Nausea and vomiting Scores using a four-point verbal scale. (None =no nausea, mild =nausea but no vomiting, moderate=vomiting one attack, severe =vomiting >one
first 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Khaled Al Awad, Professor, National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Actual)

May 15, 2025

Study Completion (Actual)

May 15, 2025

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 16, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rhomboid block in nephrectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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