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Bilevel Erector Spinae Plane Block Versus Pectoserratus Block for Analgesia in Modified Radical Mastectomy

10. juni 2026 opdateret af: Ayman Sharawy Abdel Rahman Aboul Nasr, National Cancer Institute, Egypt

Bilevel Erector Spinae Plane Block Versus Pecto-serratus Block for Analgesia in Modified Radical Mastectomy in Cancer Surgery

Breast cancer remains the most frequently diagnosed cancer and a major cause of cancer-related mortality among women worldwide. Modified radical mastectomy (MRM), a common surgical procedure for breast cancer, is associated with significant postoperative pain, which may delay recovery and contribute to the development of chronic postmastectomy pain syndrome (PMPS). To address this, regional anesthesia techniques have been increasingly incorporated into multimodal analgesia strategies to reduce opioid consumption and enhance patient outcomes. Interfascial plane blocks, in particular, offer safe and effective analgesia under ultrasound guidance. The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Breast cancer is the most common diagnosed malignancy among females and the 5th cause of cancer-related deaths with an estimated number of 2.3 million new cases and 685,000 deaths worldwide in 2020.

Different modalities are used for management of breast cancer including surgery, radiation therapy (RT), chemotherapy (CT), endocrine (hormone) therapy (ET), and targeted therapy. Modified Radical Mastectomy (MRM) is one of the main modalities of breast cancer treatment. It accounts for 31% of all breast surgeries. It has been reported that 40% of the females complain from moderate-to-severe pain in the immediate post-operative period after breast cancer surgery.

Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.

Various regional anesthetic techniques have been described for postoperative pain relief after mastectomy, for example, thoracic epidural anesthesia, intercostal nerve block, paravertebral block, serratus anterior plane block, and pectoral nerve I and II blocks. All of them offer satisfactory pain relief after mastectomy.

The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Egypten
      • Cairo, Egypten, 11796
        • Rekruttering
        • National Cancer Institute - Cairo University
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Breast cancer female patients.
  2. ASA class II and III.
  3. Age ≥ 18 and ≤ 65 Years.
  4. Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
  5. Type of surgery; elective breast cancer surgery modified radical mastectomy combined with axillary dissection.

Exclusion Criteria:

  1. Patient refusal.
  2. Age <18 years or >65 years.
  3. BMI <20 kg/m2 and >35 kg/m2.
  4. Major medical conditions.
  5. Pregnancy or lactation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Ultrasound guided bilevel Erector spinae plane block (ESPB)
Before induction of general anesthesia, patients will be positioned in the sitting position leaning forward. The 3rd and 5th vertebral spinous processes will be first identified then the block area will be adequately sterilized and draped. The block will be done as needed using either a high frequency linear probe (6- 13 MHz) or a curved (2-5 MHz) probe of . The probe used to identify the hyperechoic transverse process shadow at approximately 1.5- 2 cm distance from the spinous process deep to the trapezius, rhomboid major, and erector spinae muscles at 3rd, 5th vertebrae. Then, an 18-gauge epidural needle will be inserted in a cephalad-to-caudad direction to reach the transverse process deep to the erector spinae muscle. Correct positioning of the needle will be confirmed through real time visualization of 2 ml saline hydro dissection at both 3rd and 5th vertebrae.20 ml of bupivacaine 0.25% will be injected at each level.
Procedure: Ultrasound guided bilevel Erector spinae plane block (ESPB)
Ultrasound guided bilevel Erector spinae plane block
Aktiv komparator: Ultrasound guided Pectoserratus Block (PSPB)
For the PECS block, the patient's arm is abducted 90° and externally rotated. The ultrasound probe is positioned beneath the lateral third of the clavicle to locate the axillary vessels and subclavian artery. The probe is moved distally and laterally to the second and third rib space to identify the pectoralis major. A 20G, 100 mm echogenic needle is inserted between the pectoralis muscles; 15 mL of local anesthetic (LA) is administered in 5 cc increments. The probe is then shifted distally and laterally to the third and fourth rib space. The fascial plane between the pectoralis minor and serratus anterior muscles is identified , and 10 mL of LA is injected in 5 cc increments. For the SAPB, the probe is placed on the midaxillary line at the fifth rib level to visualize the serratus anterior and latissimus dorsi. A 22G spinal needle is inserted in-plane at a 45° angle toward the fifth rib. Saline (0.5-1 mL) is injected to open the plane, and 15 mL of 0.25% LA is administered
Procedure: Ultrasound guided Pectoserratus Block
ultra sound guided combined Pectoral Nerve (PECS II) Block and Serratus anterior (SAPB) plane block
Ingen indgriben: control group
the patients of this group received general anesthesia without regional plane block

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet postoperativ morfinforbrug.
Tidsramme: 24 timer efter operationen
Det samlede 24-timers morfinforbrug vil blive registreret for hver patient postoperativt.
24 timer efter operationen

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet intraoperativt fentanylforbrug
Tidsramme: 2-3 timer (Operationstid) operation
redningsanalgesien vil blive administreret intraoperativt af fentanyl IV, og den samlede anvendte fentanyl vil blive registreret og sammenlignet mellem grupperne
2-3 timer (Operationstid) operation
Smertescore ved hjælp af visuel analog score
Tidsramme: 24 timer efter operationen
Smertescore ved hjælp af Visual Analog score (VAS) (0 mm = ingen smerte til 10 mm = værst tænkelige smerte) med forudbestemte tidsintervaller (1, 2, 6, 12 og 24 timer) postoperativt.
24 timer efter operationen
1. gang anmodet om opioider postoperativt.
Tidsramme: 24 timer efter operationen
I tilfælde af postoperativ smerte registreret, vil redningsanalgesi blive givet som IV morfin (3 mg) derefter kontinuerlig infusion af morfin gennem patientkontrolleret analgesi (PCA) for at holde VAS-scorerne
24 timer efter operationen
Ændringer og stabilitet i det gennemsnitlige arterielle blodtryk (MAP)
Tidsramme: hvert 15. minut under operationen og derefter 1, 2, 4, 8, 12, 16, 20 og 24 timer postoperativt
Ændring i det gennemsnitlige arterielle blodtryk (MAP) i mmHg
hvert 15. minut under operationen og derefter 1, 2, 4, 8, 12, 16, 20 og 24 timer postoperativt
Ændringer og stabilitet i hjertefrekvens (HR)
Tidsramme: hvert 15. minut under operationen og derefter 1, 2, 4, 8, 12, 16, 20 og 24 timer postoperativt
Ændring i hjertefrekvens (HR) i slag\min
hvert 15. minut under operationen og derefter 1, 2, 4, 8, 12, 16, 20 og 24 timer postoperativt

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute, Egypt

Efterforskere

  • Studieleder: Ayman Sharawy Abdelrahman Aboul Nasr, MD, National Cancer Institute Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

2. august 2026

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AP2601-201-221-206

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Brystkræft

Kliniske forsøg med Ultrasound guided bilevel Erector spinae plane block (ESPB)

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