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

Not Applicable

Recruiting

• Conditions: Thoracic; Pain
• Interventions: Drug: Bupivacain; Device: Ultrasound

• Registration Number: NCT06856538
• Lead Sponsor: Yasser S Mostafa, MD

Brief Summary

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.

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 Timeline

• Study Start: 2025-02-01
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-28
• Status Verified: 2025-03
• Study First Posted: 2025-03-04
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-09-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group R	Bupivacain	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.
Group R	Ultrasound	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.
Group S	Bupivacain	* 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.
Group S	Ultrasound	* 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.

Primary Outcome Measures

Name	Time	Method
Total opioid consumption	24 hours postoperatively.	in microgram

Secondary Outcome Measures

Name	Time	Method
Visual analog pain score at rest	24 hours postoperatively.	Ranging from 0 indicating no pain to 10 indicating extreme pain
Visual analog pain score at cough	24 hours postoperatively.	Ranging from 0 indicating no pain to 10 indicating extreme pain
Time of first rescue analgesic	5 minutes before first analgesic request	in minutes
Baseline Heart rate	5 minutes before anesthesia	Beat / minute
Intraoperative Heart rate	every 30 minutes along operation	Beat / minute
Baseline mean arterial blood pressure	5 minutes before anesthesia	mmHg
Intraoperative mean arterial blood pressure	every 30 minutes along operation	mmHg
Baseline oxygen saturation	5 minutes before anesthesia	percentage with pulse oximetry
Intraoperative oxygen saturation	every 30 minutes along operation	percentage with pulse oximetry
Total length of stay in hospital	1-2 days	in days
Patient satisfaction score	12 hours after end of operation and extubation	5 degree Likeart scale where 1 Extremely satisfied to 5 Extremely not satisfied
Incidence of hematoma	30 minutes after nerve block	Yes or no
Incidence of local anesthetic toxicity	30 minutes after nerve block	Yes or no
Incidence of nausea	24 hours postoperative	Yes or no
Incidence of vomiting	24 hours postoperative	Yes or no
Ramsay sedation score	24 hours postoperative	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
Total intraoperative opioid consumption	from begining of operation till 5 minutes after extubation	in microgram

Trial Locations

Locations (1)

Fayoum University hospital; 🇪🇬 Madīnat al Fayyūm, Faiyum Governorate, Egypt