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

Not Applicable

Completed

• Conditions: Post Operative Pain
• Interventions: Procedure: Erector spinae plane block; Procedure: Rhomboid intercostal subserratus plane block; Procedure: Thoraccic Epidural analgesia

• Registration Number: NCT05822011
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-04-18
• Study Start: 2023-04-20
• Study First Posted: 2023-04-20
• Status Verified: 2025-05
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-15
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector spinae block	Erector spinae plane 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.
Rhomboid intercostal block	Rhomboid intercostal subserratus plane 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.
Thoracic epidural analgesia	Thoraccic 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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
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
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
Total amount fentanyl in (microgram)	intra operative duration	total amount of intraoperative fentanyl consumed in micrograms
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

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt