Clinical trial NCT06856538: Rhomboid Intercostal Sub Serratus Plane Block Versus Serratus Anterior Plane Block in Thoractomy
Official title: Analgesic Efficacy of Ultrasound-Guided Rhomboid Intercostal Sub Serratus Plane Block Versus Serratus Anterior Plane Block With General Anesthesia in Thoracotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic
Pain
Keywords: Rhomboid intercostal block
serratus anterior plane block
Thoracotomy
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After endotracheal intubation, just before the block, the patients were randomly allocated into two groups based on a computerized randomization table created by a researcher who was not involved in the study. The researcher assigned a random ID to each patient, and a blinded anesthesiologist used this ID while collecting the postoperative data in the surgical ward.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total opioid consumption
timeFrame: 24 hours postoperatively.
Secondary outcomes:
measure: Total intraoperative opioid consumption
timeFrame: from begining of operation till 5 minutes after extubation
measure: Visual analog pain score at rest
timeFrame: Immediately after the procedures
measure: Visual analog pain score at cough
timeFrame: Immediately after the procedures
measure: Visual analog pain score at rest
timeFrame: 1 hour postoperatively.
measure: Visual analog pain score at cough
timeFrame: 1 hour postoperatively.
measure: Visual analog pain score at rest
timeFrame: 3 hours postoperatively.
measure: Visual analog pain score at cough
timeFrame: 3 hours postoperatively.
measure: Visual analog pain score at rest
timeFrame: 6 hours postoperatively.
measure: Visual analog pain score at cough
timeFrame: 6 hours postoperatively.
measure: Visual analog pain score at rest
timeFrame: 12 hours postoperatively.
measure: Visual analog pain score at cough
timeFrame: 12 hours postoperatively.
measure: Visual analog pain score at rest
timeFrame: 24 hours postoperatively.
measure: Visual analog pain score at cough
timeFrame: 24 hours postoperatively.
measure: Time of first rescue analgesic
timeFrame: 5 minutes before first analgesic request
measure: Baseline Heart rate
timeFrame: 5 minutes before anesthesia
measure: Intraoperative Heart rate
timeFrame: every 30 minutes along operation
measure: Baseline mean arterial blood pressure
timeFrame: 5 minutes before anesthesia
measure: Intraoperative mean arterial blood pressure
timeFrame: every 30 minutes along operation
measure: Baseline oxygen saturation
timeFrame: 5 minutes before anesthesia
measure: Intraoperative oxygen saturation
timeFrame: every 30 minutes along operation
measure: Total length of stay in hospital
timeFrame: 1-2 days
measure: Patient satisfaction score
timeFrame: 12 hours after end of operation and extubation
measure: Incidence of hematoma
timeFrame: 30 minutes after nerve block
measure: Incidence of local anesthetic toxicity
timeFrame: 30 minutes after nerve block
measure: Incidence of nausea
timeFrame: 24 hours postoperative
measure: Incidence of vomiting
timeFrame: 24 hours postoperative
measure: Ramsay sedation score
timeFrame: 24 hours postoperative
Other outcomes:
measure: Age
timeFrame: 5 minutes before entering operation department
measure: Sex
timeFrame: 5 minutes before entering operation department
Locations:
city: Madīnat al Fayyūm
country: Egypt
facility: Fayoum University hospital
state: Faiyum Governorate
Study officials:
affiliation: Fayoum University
name: Mahdy A Abdelhady, MD
role: STUDY_CHAIR
affiliation: Fayoum University
name: Mohamed A Hamed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fayoum University
name: Mina M Sobhy, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.