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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05822011
Collaborator
(none)
105
Enrollment
3
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Rhomboid intercostal subserratus plane block
  • Procedure: Erector spinae plane block
  • Procedure: Thoraccic Epidural analgesia
 N/A

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. Epidural analgesia-related significant complications can include epidural hematoma, postoperative neurologic deficit, and post-dural puncture headache, and anesthesiologists are searching for alternative analgesic modalities that have adequate analgesia and a lower complication risk.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ultrasound Guided Rhomboid Intercostal Subserratus Plane Block Versus Erector Spinae Plane Block in Open Nephrectomy. Randomized Controlled Study
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

    		•
    Active Comparator: Thoracic epidural analgesia

    While the patient in the sitting position, the T7-T8 interspace can be identified. Then, skin infiltration with 2 ml of 1% lidocaine will be performed. Then, an 18-G Tuohy needle with a 20-G catheter (Perifix®, B.Braun, Germany) will be inserted through, and the epidural space will be located using the loss of resistance approach, then the patient will be given (5-10 mL) of bupivacaine 0.25% and rested into the supine position.

    Procedure: Thoraccic Epidural analgesia
    Neuroaxial block
    Other Names:
  • TEA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The total amount of morphine consumption in (mg) [first 24 hours postoperatively.]

      amount of morphine in mg consumed in 1st 24 hours

    Secondary Outcome Measures

    1. Time of first request of analgesia [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) [intra operative duration]

      total amount of intraoperative fentanyl consumed in micrograms

    3. Change in heart rate in (beat/min) [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) [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahmed Mahmoud Saad, Assistant Lecturer of Anesthesia, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05822011
    Other Study ID Numbers:
    • Rhomboid block in nephrectomy
    First Posted:
    Apr 20, 2023
    Last Update Posted:
    Apr 20, 2023
    Last Verified:
    Apr 1, 2023
    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
    Keywords provided by Ahmed Mahmoud Saad, Assistant Lecturer of Anesthesia, Cairo University
    Rhomboid intercostal block
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Apr 20, 2023