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Clinical Trials/NCT05822011
NCT05822011
Completed
Not Applicable

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

Cairo University1 site in 1 country42 target enrollmentApril 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Operative Pain
Sponsor
Cairo University
Enrollment
42
Locations
1
Primary Endpoint
The total amount of morphine consumption in (mg)
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2023
End Date
May 15, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mahmoud Saad

Assistant Lecturer of Anesthesia

Cairo University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

The total amount of morphine consumption in (mg)

Time Frame: first 24 hours postoperatively.

amount of morphine in mg consumed in 1st 24 hours

Secondary Outcomes

  • Change in heart rate in (beat/min)(From just before induction till 24 hours post operatively)
  • Time of first request of analgesia(first 24 hours postoperatively)
  • Numeric Pain Rating Scale(first 24 hours postoperatively)
  • Nausea and vomiting Scores(first 24 hours postoperatively)
  • Total amount fentanyl in (microgram)(intra operative duration)
  • Change in mean arterial blood pressure in (mmHg)(From just before induction till 24 hours post operatively)

Study Sites (1)

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