Rhomboid Intercostal Sub Serratus Plane Block Versus Serratus Anterior Plane Block in Thoractomy

Analgesic Efficacy of Ultrasound-Guided Rhomboid Intercostal Sub Serratus Plane Block Versus Serratus Anterior Plane Block With General Anesthesia in Thoracotomy

The objective of the current study is to compare the efficacy of the analgesic effect of ultrasound-guided unilateral Rhomboid intercostal and sub serratus plane block (RISS) versus Serratus anterior plane block (SAPB) in Thoracotomy incision.

Study Overview

• Status: Recruiting
• Conditions: Pain; Thoracic
• Intervention / Treatment: Device: Ultrasound; Drug: Bupivacain

Detailed Description

Open thoracotomy is commonly considered to be one of the most agonizing surgical operations. Pain following thoracotomy greatly impedes patient recovery and postoperative respiration. The pain experienced after a thoracotomy can originate from various factors, including the surgical incision, injury to the ribs and intercostal nerves, manipulation of the pleura and lung tissue, and the placement of a drainage tube.Recent advances in regional anesthesia techniques have aimed to provide more targeted and effective pain relief. Among these, ultrasound-guided fascial plane blocks, such as the rhomboid intercostal sub-serratus plane (RISS) block and the serratus anterior plane (SAP) block, have emerged as promising options. Both blocks target the thoracic nerves, but they differ in their anatomical approach and potential analgesic effects Postoperative pain was not only related to a comfortable recovery but also related to postoperative complications including pulmonary dysfunction, so the management of postoperative pain is an important part of the care of post operation.

Regional anesthesia techniques have been shown to have a good effect on postoperative analgesia and helps patients gain early recovery after operation.

Serratus anterior plane block (SAPB) is an easy, and safe method used for blockade of the sensory plane of the lateral cutaneous branch of the intercostal nerve (T2-T9).

The Serratus anterior plane block targets the lateral cutaneous branches of the thoracic intercostal nerves, which arise from the anterior rami of the thoracic spinal nerves and run in a neurovascular bundle immediately inferior to each rib. At the midaxillary line, the lateral cutaneous branches of the thoracic intercostal nerve traverse through the internal intercostal, external intercostal, and serratus anterior muscles innervating the musculature of the lateral thorax. These branches of the intercostal nerves travel through the two potential spaces described above.

The "Rhomboid intercostal and sub serratus plane block" (RISS) is a relatively newer block technique whose efficacy was documented in patients undergoing thoracic surgeries.

The RISS plane block involves the injection of local anesthetics into fascial planes, theoretically allowing for catheter placement to achieve continuous analgesia. Successful RISS plane blocks have been reported in various procedures, including lung transplantation, radical mastectomy, and nephrectomy, strongly suggesting favorable outcomes in postoperative pain relief.

In 2016, Elsharkawy et al. introduced a RA technique known as the rhomboid intercostal block (RIB). Rhomboid intercostal block involves injecting a local anesthetic into the upper intercostal muscle plane beneath the rhomboid muscles, providing analgesia to both the anterior and posterior thorax.Based on past studies, investigators found that RISS and SAPB are effectively decrease total opioid consumption, so investigators hypothesized one of them is the best.

Statistical analysis:

Statistical analysis will be conducted using IBM SPSS Statistics 22(IBM Corp., Armonk, NY, USA). The normal distribution of data will be assessed by the Kolmogorov-Smirnov and Shapiro-Wilk tests. Mean and standard deviation will be used as descriptive statistics for normally distributed numerical variables, while median and interquartile range (25th to 75th percentiles) will be used as descriptive statistics for non-normally distributed numerical variables. In addition, Chi-square test or fisher exact test will be employed to test the significance between categorical variables as appropriate. Independent t test will be employed for numerical data that exhibited normal distribution, whereas the Mann-Whitney test will be used for numerical data that did not adhere to normal distribution. A significance level of p < 0.05 will be deemed to be statistically significant.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emad El Mohamed Abd El-Razek, M.Sc.; Phone Number: +2 0 109 400 6418; Email: ema18@fayoum.edu.eg
• Study Contact Backup: Name: Yasser S Mostafa, MD; Phone Number: +2 01010509735; Email: ysm03@fayoum.edu.eg

Study Locations

• Egypt
  • Faiyum Governorate
    • Madīnat al Fayyūm, Faiyum Governorate, Egypt, 63514
      • Recruiting
      • Fayoum University hospital
      • Contact: Mohamed A Hamed, MD.; Phone Number: +20 010105093736; Email: mah07@fayoum.edu.eg
      • Contact: Yasser S Mostafa, M.D.; Phone Number: +20 1010509735; Email: ysm03@fayoum.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients aged 18-70 years.
• Patients scheduled for unilateral Thoracotomy.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Patients who are candidates for general anesthesia.
• No history of severe allergies to local anesthetics or other medications used during the procedure.

Exclusion Criteria:

• ASA PS class ≥ IV patients.
• obese (BMI ≥ 35) patients.
• Patients with uncontrolled cardiovascular.
• patients with neurological deficits, cardiopulmonary, hepatorenal , or metabolic diseases; anticoagulants; any drug allergies.
• Patients with emergency surgeries or re-do surgeries.
• Systemic infections or infections at the site of injection.
• Psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression).
• Narcotic dependency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group R; A high- frequency linear ultrasound transducer will be placed longitudinally (in the sagittal plane) on the patient's back, just 2 cm medial to the medial scapular border. Then, the probe will be slightly rotated to obtain an oblique parasagittal plane. The following landmarks will be identified: the trapezius muscle, rhomboid major muscle, intercostal muscles, pleura, and lungs (from superficial to deep in order of appearance). The rhomboid major muscle will be distinguished at the level of the T6 and T7 vertebrae, below the trapezius muscle.	Device: Ultrasound; A linear US transducer (Phillips-Saronno Italy) was placed vertically 3 cm lateral to the midline to visualize back muscles: the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, as well as the TPs with shimmering pleura in between.; Drug: Bupivacain; After the location will be confirmed through hydrodissection of 1 ml on the plane between the rhomboid major and the underlying intercostal muscles after confirming a negative aspiration via a a 22-gauge short bevel sonovisible needle (Spinocan, B. Braun Melsungen AG, Germany) using an in-plane technique then 10 ml of bupivacaine (concentration 0.25%) will be injected. and its spread will be manifested by the hydrodissection and widening of the plane visualized by ultrasound.; Other Names: Marcaine 0.25%
Active Comparator: Group S; The patient will be positioned laterally, and routine skin disinfection and draping will be completed.; Investigators also will use a linear ultrasound probe (Philips clear vue350, Philips healthcare, Andover MAO1810, USA, Machine ID: 1385, Nile medical center, service@nilemed.net) for performing the block.; The fifth rib will be identified along the mid-axillary line to locate the deep serratus anterior muscle and the superficial latissimus dorsi muscle.; The needle will be inserted between the fifth and fourth ribs using a 22G (50 mm) puncture needle.	Device: Ultrasound; A linear US transducer (Phillips-Saronno Italy) was placed vertically 3 cm lateral to the midline to visualize back muscles: the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, as well as the TPs with shimmering pleura in between.; Drug: Bupivacain; After the location will be confirmed through hydrodissection of 1 ml on the plane between the rhomboid major and the underlying intercostal muscles after confirming a negative aspiration via a a 22-gauge short bevel sonovisible needle (Spinocan, B. Braun Melsungen AG, Germany) using an in-plane technique then 10 ml of bupivacaine (concentration 0.25%) will be injected. and its spread will be manifested by the hydrodissection and widening of the plane visualized by ultrasound.; Other Names: Marcaine 0.25%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	in microgram	24 hours postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative opioid consumption	in microgram	from begining of operation till 5 minutes after extubation
Visual analog pain score at rest	Ranging from 0 indicating no pain to 10 indicating extreme pain	Immediately after the procedures
Visual analog pain score at cough	Ranging from 0 indicating no pain to 10 indicating extreme pain	Immediately after the procedures
Visual analog pain score at rest	Ranging from 0 indicating no pain to 10 indicating extreme pain	1 hour postoperatively.
Visual analog pain score at cough	Ranging from 0 indicating no pain to 10 indicating extreme pain	1 hour postoperatively.
Visual analog pain score at rest	Ranging from 0 indicating no pain to 10 indicating extreme pain	3 hours postoperatively.
Visual analog pain score at cough	Ranging from 0 indicating no pain to 10 indicating extreme pain	3 hours postoperatively.
Visual analog pain score at rest	Ranging from 0 indicating no pain to 10 indicating extreme pain	6 hours postoperatively.
Visual analog pain score at cough	Ranging from 0 indicating no pain to 10 indicating extreme pain	6 hours postoperatively.
Visual analog pain score at rest	Ranging from 0 indicating no pain to 10 indicating extreme pain	12 hours postoperatively.
Visual analog pain score at cough	Ranging from 0 indicating no pain to 10 indicating extreme pain	12 hours postoperatively.
Visual analog pain score at rest	Ranging from 0 indicating no pain to 10 indicating extreme pain	24 hours postoperatively.
Visual analog pain score at cough	Ranging from 0 indicating no pain to 10 indicating extreme pain	24 hours postoperatively.
Time of first rescue analgesic	in minutes	5 minutes before first analgesic request
Baseline Heart rate	Beat / minute	5 minutes before anesthesia
Intraoperative Heart rate	Beat / minute	every 30 minutes along operation
Baseline mean arterial blood pressure	mmHg	5 minutes before anesthesia
Intraoperative mean arterial blood pressure	mmHg	every 30 minutes along operation
Baseline oxygen saturation	percentage with pulse oximetry	5 minutes before anesthesia
Intraoperative oxygen saturation	percentage with pulse oximetry	every 30 minutes along operation
Total length of stay in hospital	in days	1-2 days
Patient satisfaction score	5 degree Likeart scale where 1 Extremely satisfied to 5 Extremely not satisfied	12 hours after end of operation and extubation
Incidence of hematoma	Yes or no	30 minutes after nerve block
Incidence of local anesthetic toxicity	Yes or no	30 minutes after nerve block
Incidence of nausea	Yes or no	24 hours postoperative
Incidence of vomiting	Yes or no	24 hours postoperative
Ramsay sedation score	From 1 to 5 (1 Awake; agitated or restless or both - 2 Awake; cooperative, oriented, and tranquil - 3 Awake but responds to commands only - 4 Asleep; brisk response to light glabellar tap or loud auditory stimulus - 5 Asleep; sluggish response to light glabellar tap or loud auditory stimulus) Asleep; no response to glabellar tap or loud auditory stimulus	24 hours postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	in years	5 minutes before entering operation department
Sex	Male of female	5 minutes before entering operation department

Collaborators and Investigators

• Sponsor: Yasser S Mostafa, MD
• Investigators: Principal Investigator: Mohamed A Hamed, MD, Fayoum University; Study Chair: Mahdy A Abdelhady, MD, Fayoum University; Study Director: Mina M Sobhy, MD, Fayoum University

Publications and helpful links

General Publications

• Altiparmak B, Korkmaz Toker M, Uysal AI, Dere O, Ugur B. Evaluation of ultrasound-guided rhomboid intercostal nerve block for postoperative analgesia in breast cancer surgery: a prospective, randomized controlled trial. Reg Anesth Pain Med. 2020 Apr;45(4):277-282. doi: 10.1136/rapm-2019-101114. Epub 2020 Feb 19.
• Hassan ME, Wadod MAA. Serratus anterior plane block and erector spinae plane block in postoperative analgesia in thoracotomy: A randomised controlled study. Indian J Anaesth. 2022 Feb;66(2):119-125. doi: 10.4103/ija.ija_257_21. Epub 2022 Feb 24.
• Longo F, Piliego C. Rhomboid intercostal and subserratus plane block for non-intubated video-assisted thoracoscopic surgery. J Clin Anesth. 2020 May;61:109612. doi: 10.1016/j.jclinane.2019.09.006. Epub 2019 Oct 24. No abstract available. Erratum In: J Clin Anesth. 2020 Aug;63:109789. doi: 10.1016/j.jclinane.2020.109789.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Thoracotomy; serratus anterior plane block; Rhomboid intercostal block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: D404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No