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

NCT06856538 | Recruiting

• 1 other identifier: D404
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic; Pain

Keywords

Rhomboid intercostal block; serratus anterior plane block; Thoracotomy

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  in microgram

  24 hours postoperatively.

Secondary Outcomes (27)

• Total intraoperative opioid consumption

  from begining of operation till 5 minutes after extubation

• Visual analog pain score at rest

  Immediately after the procedures

• Visual analog pain score at cough

  Immediately after the procedures

• Visual analog pain score at rest

  1 hour postoperatively.

• Visual analog pain score at cough

  1 hour postoperatively.

Other Outcomes (2)

• Age

  5 minutes before entering operation department

• Sex

  5 minutes before entering operation department

Study Arms (2)

Group R

EXPERIMENTAL

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.

Drug: Bupivacain; Device: Ultrasound

Group S

ACTIVE 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.

Drug: Bupivacain; Device: Ultrasound

Interventions

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.

Also known as: Marcaine 0.25%

Group R; Group S

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.

Group R; Group S

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yasser S Mostafa, MD: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 32079739 BACKGROUND

• 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.

  PMID: 31668692 BACKGROUND

• 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.

  PMID: 35359482 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Ultrasonography

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mahdy A Abdelhady, MD

  Fayoum University

  STUDY CHAIR

• Mohamed A Hamed, MD

  Fayoum University

  PRINCIPAL INVESTIGATOR

• Mina M Sobhy, MD

  Fayoum University

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

0 109 400 6418; ema18@fayoum.edu.eg

Yasser S Mostafa, MD

CONTACT

01010509735; ysm03@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 4, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)