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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06856538
Enrollment
40
Registered
2025-03-04
Start date
2025-02-01
Completion date
2026-10-01
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Thoracic

Keywords

Rhomboid intercostal block, serratus anterior plane block, Thoracotomy

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.

Interventions

DRUGBupivacain

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.

DEVICEUltrasound

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.

Sponsors

Yasser S Mostafa, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Triple (Participant, Care Provider, Outcomes Assessor) Apart from the anesthesiologists who performed the blocks, all patients, surgeons, and postoperative nurses remained blinded to randomization throughout the study period.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Total opioid consumption24 hours postoperatively.in microgram

Secondary

MeasureTime frameDescription
Intraoperative Heart rateevery 30 minutes along operationBeat / minute
Baseline mean arterial blood pressure5 minutes before anesthesiammHg
Intraoperative mean arterial blood pressureevery 30 minutes along operationmmHg
Baseline oxygen saturation5 minutes before anesthesiapercentage with pulse oximetry
Intraoperative oxygen saturationevery 30 minutes along operationpercentage with pulse oximetry
Total length of stay in hospital1-2 daysin days
Visual analog pain score at restImmediately after the proceduresRanging from 0 indicating no pain to 10 indicating extreme pain
Incidence of vomiting24 hours postoperativeYes or no
Ramsay sedation score24 hours postoperativeFrom 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 consumptionfrom begining of operation till 5 minutes after extubationin microgram
Baseline Heart rate5 minutes before anesthesiaBeat / minute
Visual analog pain score at coughImmediately after the proceduresRanging from 0 indicating no pain to 10 indicating extreme pain
Time of first rescue analgesic5 minutes before first analgesic requestin minutes
Patient satisfaction score12 hours after end of operation and extubation5 degree Likeart scale where 1 Extremely satisfied to 5 Extremely not satisfied
Incidence of hematoma30 minutes after nerve blockYes or no
Incidence of local anesthetic toxicity30 minutes after nerve blockYes or no
Incidence of nausea24 hours postoperativeYes or no

Other

MeasureTime frameDescription
Sex5 minutes before entering operation departmentMale of female
Age5 minutes before entering operation departmentin years

Countries

Egypt

Contacts

Primary ContactEmad El Mohamed Abd El-Razek, M.Sc.
ema18@fayoum.edu.eg0 109 400 6418
Backup ContactYasser S Mostafa, MD
ysm03@fayoum.edu.eg01010509735

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026