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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822011
• Other study ID #: Rhomboid block in nephrectomy
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: April 2024

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: Ahmed Ma saad, Ass Lecturer
• Phone: 01229781573
• Email: abosaaddr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Rhomboid intercostal subserratus plane block
Fascial plane block
• Erector spinae plane block
Fascial plane block
• Thoraccic Epidural analgesia
Neuroaxial block

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total amount of morphine consumption in (mg)	amount of morphine in mg consumed in 1st 24 hours	first 24 hours postoperatively.
Secondary	Time of first request of analgesia	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)	first 24 hours postoperatively
Secondary	Total amount fentanyl in (microgram)	total amount of intraoperative fentanyl consumed in micrograms	intra operative duration
Secondary	Change in heart rate in (beat/min)	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	From just before induction till 24 hours post operatively
Secondary	Change in mean arterial blood pressure in (mmHg)	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	From just before induction till 24 hours post operatively
Secondary	Numeric Pain Rating Scale	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	first 24 hours postoperatively
Secondary	Nausea and vomiting Scores	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	first 24 hours postoperatively