AzTrials
AzTrials

ThoracicNCT06856538

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

A study testing Bupivacain and Ultrasound in people with Thoracic and Pain, run by Yasser S Mostafa, MD at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Thoracic, Pain
What is being tested?
Bupivacain and Ultrasound
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Feb 2025to 1 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum University hospital

    El Fayoum Qesm, Faiyum Governorate, 63514

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Conditions
Thoracic, Pain
Being tested
Bupivacain, Ultrasound
Keywords
Rhomboid intercostal block, serratus anterior plane block, Thoracotomy
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BupivacainDrug

    Also called Marcaine 0.25%

    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.

  • UltrasoundDevice

    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.

Study groups in NCT06856538
Study groupRoleWhat they receive
Group RExperimentalA 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.
Receives: Drug: Bupivacain; Device: Ultrasound
Group SActive comparator* 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.
Receives: Drug: Bupivacain; Device: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total opioid consumption

    in microgram

    Measured: 24 hours postoperatively.

Secondary outcomes (27)
  1. Total intraoperative opioid consumption

    in microgram

    Measured: from begining of operation till 5 minutes after extubation

  2. Visual analog pain score at rest

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: Immediately after the procedures

  3. Visual analog pain score at cough

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: Immediately after the procedures

  4. Visual analog pain score at rest

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: 1 hour postoperatively.

  5. Visual analog pain score at cough

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: 1 hour postoperatively.

  6. Visual analog pain score at rest

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: 3 hours postoperatively.

  7. Visual analog pain score at cough

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: 3 hours postoperatively.

  8. Visual analog pain score at rest

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: 6 hours postoperatively.

  9. Visual analog pain score at cough

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: 6 hours postoperatively.

  10. Visual analog pain score at rest

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: 12 hours postoperatively.

  11. Visual analog pain score at cough

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: 12 hours postoperatively.

  12. Visual analog pain score at rest

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: 24 hours postoperatively.

  13. Visual analog pain score at cough

    Ranging from 0 indicating no pain to 10 indicating extreme pain

    Measured: 24 hours postoperatively.

  14. Time of first rescue analgesic

    in minutes

    Measured: 5 minutes before first analgesic request

  15. Baseline Heart rate

    Beat / minute

    Measured: 5 minutes before anesthesia

  16. Intraoperative Heart rate

    Beat / minute

    Measured: every 30 minutes along operation

  17. Baseline mean arterial blood pressure

    mmHg

    Measured: 5 minutes before anesthesia

  18. Intraoperative mean arterial blood pressure

    mmHg

    Measured: every 30 minutes along operation

  19. Baseline oxygen saturation

    percentage with pulse oximetry

    Measured: 5 minutes before anesthesia

  20. Intraoperative oxygen saturation

    percentage with pulse oximetry

    Measured: every 30 minutes along operation

  21. Total length of stay in hospital

    in days

    Measured: 1-2 days

  22. Patient satisfaction score

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

    Measured: 12 hours after end of operation and extubation

  23. Incidence of hematoma

    Yes or no

    Measured: 30 minutes after nerve block

  24. Incidence of local anesthetic toxicity

    Yes or no

    Measured: 30 minutes after nerve block

  25. Incidence of nausea

    Yes or no

    Measured: 24 hours postoperative

  26. Incidence of vomiting

    Yes or no

    Measured: 24 hours postoperative

  27. 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

    Measured: 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study start1 Feb 2025
  3. Primary completion1 May 2026
  4. Study completion1 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06856538
Sponsor's protocol ID
D404
Status last verified
Oct 2026
First submitted
19 Feb 2025
Last updated
8 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32079739
  • 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.

    PubMed 31668692
  • 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.

    PubMed 35359482

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacain and Ultrasound in people with Thoracic and Pain, run by Yasser S Mostafa, MD at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total opioid consumption (time frame: 24 hours postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06856538, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in