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NCT Number: NCT06856538

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacain

Drug

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%

Ultrasound

Device

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.

Primary outcomes

  1. Total opioid consumption

    Time frame: 24 hours postoperatively.

    in microgram

Secondary outcomes

  1. Total intraoperative opioid consumption

    Time frame: from begining of operation till 5 minutes after extubation

    in microgram

  2. Visual analog pain score at rest

    Time frame: Immediately after the procedures

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  3. Visual analog pain score at cough

    Time frame: Immediately after the procedures

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  4. Visual analog pain score at rest

    Time frame: 1 hour postoperatively.

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  5. Visual analog pain score at cough

    Time frame: 1 hour postoperatively.

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  6. Visual analog pain score at rest

    Time frame: 3 hours postoperatively.

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  7. Visual analog pain score at cough

    Time frame: 3 hours postoperatively.

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  8. Visual analog pain score at rest

    Time frame: 6 hours postoperatively.

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  9. Visual analog pain score at cough

    Time frame: 6 hours postoperatively.

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  10. Visual analog pain score at rest

    Time frame: 12 hours postoperatively.

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  11. Visual analog pain score at cough

    Time frame: 12 hours postoperatively.

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  12. Visual analog pain score at rest

    Time frame: 24 hours postoperatively.

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  13. Visual analog pain score at cough

    Time frame: 24 hours postoperatively.

    Ranging from 0 indicating no pain to 10 indicating extreme pain

  14. Time of first rescue analgesic

    Time frame: 5 minutes before first analgesic request

    in minutes

  15. Baseline Heart rate

    Time frame: 5 minutes before anesthesia

    Beat / minute

  16. Intraoperative Heart rate

    Time frame: every 30 minutes along operation

    Beat / minute

  17. Baseline mean arterial blood pressure

    Time frame: 5 minutes before anesthesia

    mmHg

  18. Intraoperative mean arterial blood pressure

    Time frame: every 30 minutes along operation

    mmHg

  19. Baseline oxygen saturation

    Time frame: 5 minutes before anesthesia

    percentage with pulse oximetry

  20. Intraoperative oxygen saturation

    Time frame: every 30 minutes along operation

    percentage with pulse oximetry

  21. Total length of stay in hospital

    Time frame: 1-2 days

    in days

  22. Patient satisfaction score

    Time frame: 12 hours after end of operation and extubation

    5 degree Likeart scale where 1 Extremely satisfied to 5 Extremely not satisfied

  23. Incidence of hematoma

    Time frame: 30 minutes after nerve block

    Yes or no

  24. Incidence of local anesthetic toxicity

    Time frame: 30 minutes after nerve block

    Yes or no

  25. Incidence of nausea

    Time frame: 24 hours postoperative

    Yes or no

  26. Incidence of vomiting

    Time frame: 24 hours postoperative

    Yes or no

  27. Ramsay sedation score

    Time frame: 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

Other outcomes

  1. Age

    Time frame: 5 minutes before entering operation department

    in years

  2. Sex

    Time frame: 5 minutes before entering operation department

    Male of female

Study contacts

Contact information is provided by the study sponsor or research team.

Emad El Mohamed Abd El-Razek, M.Sc.

CONTACT

[email protected]

0 109 400 6418 ext. +2

Yasser S Mostafa, MD

CONTACT

[email protected]

01010509735 ext. +2

Sponsors and collaborators

Lead sponsor

Yasser S Mostafa, MD

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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