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OpenTrials
Completed

NCT Number: NCT05822011

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

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

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rhomboid intercostal subserratus plane block

Procedure

Fascial plane block

Other names: RISS

Erector Spinae Plane Block

Procedure

Fascial plane block

Other names: ESB

Primary outcomes

  1. 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

  1. 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)

  2. Total amount fentanyl in (microgram)

    Time frame: intra operative duration

    total amount of intraoperative fentanyl consumed in micrograms

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2023
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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