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

NCT05822011 | Completed

• 1 other identifier: Rhomboid block in nephrectomy
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain

Keywords

Rhomboid intercostal block

Outcome Measures

Primary Outcomes (1)

• The total amount of morphine consumption in (mg)

  amount of morphine in mg consumed in 1st 24 hours

  first 24 hours postoperatively.

Secondary Outcomes (6)

• Time of first request of analgesia

  first 24 hours postoperatively

• Total amount fentanyl in (microgram)

  intra operative duration

• Change in heart rate in (beat/min)

  From just before induction till 24 hours post operatively

• Change in mean arterial blood pressure in (mmHg)

  From just before induction till 24 hours post operatively

• Numeric Pain Rating Scale

  first 24 hours postoperatively

Study Arms (2)

Erector spinae block

ACTIVE COMPARATOR

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

Rhomboid intercostal block

ACTIVE COMPARATOR

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

Interventions

Rhomboid intercostal subserratus plane block PROCEDURE

Fascial plane block

Also known as: RISS

Rhomboid intercostal block

Erector spinae plane block PROCEDURE

Fascial plane block

Also known as: ESB

Erector spinae block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National Cancer Institute

Cairo, Egypt

Location

Related Publications (17)

• 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.

  PMID: 31727523 BACKGROUND

• 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.

  PMID: 33762197 BACKGROUND

• 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.

  PMID: 24961586 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 28188621 BACKGROUND

• 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.

  PMID: 28625453 BACKGROUND

• 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.

  PMID: 28272292 BACKGROUND

• 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.

  PMID: 35030493 BACKGROUND

• 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.

  PMID: 30169476 BACKGROUND

• 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.

  PMID: 27291611 BACKGROUND

• 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.

  PMID: 30640671 BACKGROUND

• 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.

  PMID: 31998046 BACKGROUND

• 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.

  PMID: 32046475 BACKGROUND

• 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.

  PMID: 25432552 BACKGROUND

• 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.

  PMID: 11883387 BACKGROUND

• 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.

  PMID: 32171499 BACKGROUND

• 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.

  PMID: 41120933 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Khaled Al Awad, Professor

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 20, 2023
• Study Start: April 20, 2023
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

EG (1)