Ultrasound Guided- Chemical Rectus Sheath Block for Chronic Pain After Abdominal Midline Incision in Cancer Surgeries
Evaluation of Ultrasound Guided- Chemical Rectus Sheath Block for Chronic Pain After Abdominal Midline Incision in Cancer Surgeries: A Prospective Randomized Controlled Study
The aim of this study is to evaluate peri-operative analgesia efficacy of ultrasound guided transversalis fascia plane block in cancer patients undergoing inguinal lymph node dissection
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Inguinal lymph node dissection is the surgical removal of lymph nodes from your groin (where your legs meet your lower abdomen). Inguinal lymph node dissection is used to see if cancer has spread from certain areas (usually your penis, vulva, anus or the skin on your legs or torso), remove lymph nodes that may be cancerous or have a high chance of becoming cancerous, reduce the risk that cancer will come back in the future and help providers understand the options for treating your cancer and help you know what to expect.
Transversalis fascia plane block (TFPB) used in patients undergoing various surgeries like iliac crest bone harvesting, appendicectomy, cecostomy and inguinal hernia repair, often in combination with TAP block.
The initial description of TFPB was with patients in the supine position, with a linear array or curvilinear probe placed between the iliac crest and the costal margin. The external oblique, internal oblique and transversus abdominis muscles and the transversus aponeurosis are identified.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Ahmed S Abdelgalil, MD
- Telefonnummer: 00201098426689
- E-Mail: ahmed.salah@nci.cu.edu.eg
Studienorte
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Cairo, Ägypten, 12613
- Rekrutierung
- Cairo University
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Kontakt:
- Ahmed S Abdelgalil, MD
- Telefonnummer: 00201098426689
- E-Mail: ahmed.salah@nci.cu.edu.eg
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) class I and II.
- Age ≥ 18 and ≤ 65 Years.
- Cancer patients for inguinal lymph node dissection.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Exclusion Criteria:
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathies with platelet count below 50,000 or an INR>1.6.
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
- Patients allergic to medication used.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Schein-Komparator: Group 1
Patients will receive a sham block was performed using an equivalent volume of normal saline 0.9%. |
Patients will receive a sham block was performed using an equivalent volume of normal saline 0.9%. |
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Experimental: Group 2
Patients will receive ultrasound guided transversalis fascia plane block. |
Patients will receive ultrasound guided transversalis fascia plane block.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Degree of pain
Zeitfenster: 24 hours postoperatively
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Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). |
24 hours postoperatively
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Total fentanyl consumption
Zeitfenster: Intraoperatively
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When elevation of Heart rate (HR) or mean arterial blood pressure (MAP) ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg. |
Intraoperatively
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Total opioid consumption
Zeitfenster: 24 hours postoperatively
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The patients will be observed in the postoperative care unit for 2 h, and rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score >3. The total amount of morphine given in 24 h will be recorded for every patient. |
24 hours postoperatively
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Mean arterial pressure
Zeitfenster: 24 hours postoperatively
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Mean arterial pressure will be recorded before injection of the local anesthetics to be defined as a baseline reading and after injection then will be recorded immediately before and after surgical incision, at 30 min intervals intraoperatively, and immediately postoperative and at 2, 4, 6, 12 and 24 h postoperatively. |
24 hours postoperatively
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Heart rate
Zeitfenster: 24 hours postoperatively
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Heart rate will be recorded before injection of the local anesthetics to be defined as a baseline reading and after injection then will be recorded immediately before and after surgical incision, at 30 min intervals intraoperatively, and immediately postoperative and at 2, 4, 6, 12 and 24 h postoperatively. |
24 hours postoperatively
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Incidence of complications
Zeitfenster: 24 hours postoperatively
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Incidence of complications such as hemodynamic instability, nausea, vomiting, failed block, unintentional intravascular injection of local anesthesia and local anesthetic toxicity will be recorded |
24 hours postoperatively
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 04-2026-300865
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD-Sharing-Zeitrahmen
After the end of study for one year.
IPD-Sharing-Zugriffskriterien
The data will be available upon a reasonable request from the corresponding author.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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