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

NCT ID: NCT05822011

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2025-05-15

Brief Summary

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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

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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.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type PROCEDURE

Fascial plane block

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.

Group Type ACTIVE_COMPARATOR

Rhomboid intercostal subserratus plane block

Intervention Type PROCEDURE

Fascial plane block

Interventions

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Rhomboid intercostal subserratus plane block

Fascial plane block

Intervention Type PROCEDURE

Erector spinae plane block

Fascial plane block

Intervention Type PROCEDURE

Other Intervention Names

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RISS ESB

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahmoud Saad

Assistant Lecturer of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khaled Al Awad, Professor

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

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National Cancer Institute

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Bravi CA, Larcher A, Capitanio U, Mari A, Antonelli A, Artibani W, Barale M, Bertini R, Bove P, Brunocilla E, Da Pozzo L, Di Maida F, Fiori C, Gontero P, Li Marzi V, Longo N, Mirone V, Montanari E, Porpiglia F, Schiavina R, Schips L, Simeone C, Siracusano S, Terrone C, Trombetta C, Volpe A, Montorsi F, Ficarra V, Carini M, Minervini A. Perioperative Outcomes of Open, Laparoscopic, and Robotic Partial Nephrectomy: A Prospective Multicenter Observational Study (The RECORd 2 Project). Eur Urol Focus. 2021 Mar;7(2):390-396. doi: 10.1016/j.euf.2019.10.013. Epub 2019 Nov 12.

Reference Type BACKGROUND
PMID: 31727523 (View on PubMed)

Saleh AH, Abdallah MW, Mahrous AM, Ali NA. Quadratus lumborum block (transmuscular approach) versus transversus abdominis plane block (unilateral subcostal approach) for perioperative analgesia in patients undergoing open nephrectomy: a randomized, double-blinded, controlled trial. Braz J Anesthesiol. 2021 Jul-Aug;71(4):367-375. doi: 10.1016/j.bjane.2021.01.009. Epub 2021 Mar 21.

Reference Type BACKGROUND
PMID: 33762197 (View on PubMed)

Kang XH, Bao FP, Xiong XX, Li M, Jin TT, Shao J, Zhu SM. Major complications of epidural anesthesia: a prospective study of 5083 cases at a single hospital. Acta Anaesthesiol Scand. 2014 Aug;58(7):858-66. doi: 10.1111/aas.12360. Epub 2014 Jun 24.

Reference Type BACKGROUND
PMID: 24961586 (View on PubMed)

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

Reference Type BACKGROUND
PMID: 27501016 (View on PubMed)

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

Reference Type BACKGROUND
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Ueshima H, Otake H. RETRACTED: Erector spinae plane block provides effective pain management during pneumothorax surgery. J Clin Anesth. 2017 Aug;40:74. doi: 10.1016/j.jclinane.2017.04.016. Epub 2017 Apr 28. No abstract available.

Reference Type BACKGROUND
PMID: 28625453 (View on PubMed)

Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.

Reference Type BACKGROUND
PMID: 28272292 (View on PubMed)

Oh SK, Lim BG, Won YJ, Lee DK, Kim SS. Analgesic efficacy of erector spinae plane block in lumbar spine surgery: A systematic review and meta-analysis. J Clin Anesth. 2022 Jun;78:110647. doi: 10.1016/j.jclinane.2022.110647. Epub 2022 Jan 11.

Reference Type BACKGROUND
PMID: 35030493 (View on PubMed)

Elsharkawy H, Maniker R, Bolash R, Kalasbail P, Drake RL, Elkassabany N. Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation. Reg Anesth Pain Med. 2018 Oct;43(7):745-751. doi: 10.1097/AAP.0000000000000824.

Reference Type BACKGROUND
PMID: 30169476 (View on PubMed)

Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.

Reference Type BACKGROUND
PMID: 27291611 (View on PubMed)

Elsharkawy H, Pawa A, Mariano ER. Reply to Dr Price: Interfascial plane blocks - a Time to Pause. Reg Anesth Pain Med. 2019 Jan;44(1):138. doi: 10.1136/rapm-2018-100020. Epub 2018 Dec 19. No abstract available.

Reference Type BACKGROUND
PMID: 30640671 (View on PubMed)

Sharma SK, Mistry T, Ahmed S. Ultrasound-guided thoracic erector spinae plane block: A modified transverse approach. Saudi J Anaesth. 2020 Jan-Mar;14(1):142-143. doi: 10.4103/sja.SJA_624_19. Epub 2020 Jan 6. No abstract available.

Reference Type BACKGROUND
PMID: 31998046 (View on PubMed)

Elsharkawy H, Hamadnalla H, Altinpulluk EY, Gabriel RA. Rhomboid intercostal and subserratus plane block -a case series. Korean J Anesthesiol. 2020 Dec;73(6):550-556. doi: 10.4097/kja.19479. Epub 2020 Feb 12.

Reference Type BACKGROUND
PMID: 32046475 (View on PubMed)

Lichtenstein D, van Hooland S, Elbers P, Malbrain ML. Ten good reasons to practice ultrasound in critical care. Anaesthesiol Intensive Ther. 2014 Nov-Dec;46(5):323-35. doi: 10.5603/AIT.2014.0056.

Reference Type BACKGROUND
PMID: 25432552 (View on PubMed)

Apfel CC, Kranke P, Eberhart LH, Roos A, Roewer N. Comparison of predictive models for postoperative nausea and vomiting. Br J Anaesth. 2002 Feb;88(2):234-40. doi: 10.1093/bja/88.2.234.

Reference Type BACKGROUND
PMID: 11883387 (View on PubMed)

Sakae TM, Yamauchi LHI, Takaschima AKK, Brandao JC, Benedetti RH. [Comparison between erector spinal plane block and epidural block techniques for postoperative analgesia in open cholecystectomies: a randomized clinical trial]. Braz J Anesthesiol. 2020 Jan-Feb;70(1):22-27. doi: 10.1016/j.bjan.2019.12.009. Epub 2020 Feb 27.

Reference Type BACKGROUND
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Eltwab DA, Abed SM, Saad A, Aliem MAA, Elsamahy KA, Elshamy FH, Gad AF, Elsabeeny WY. Ultrasound-guided erector spinae plane block versus rhomboid intercostal sub-serratus plane block for postoperative analgesia in open radical nephrectomy: a randomized clinical study. BMC Anesthesiol. 2025 Oct 22;25(1):514. doi: 10.1186/s12871-025-03377-4.

Reference Type DERIVED
PMID: 41120933 (View on PubMed)

Other Identifiers

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Rhomboid block in nephrectomy

Identifier Type: -

Identifier Source: org_study_id

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