- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05516901
Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Epigastric Hernia
Effect of Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Obese Patients Undergoing Epigastric Hernia Repair
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Ventral hernia repair is an operation associated with significant postoperative pain. There is a lot of modalities of pain control including regional anesthesia, intravenous opioids, and non-opioid analgesics. Regional anesthesia is often helpful in improving respiratory function and analgesia.
The dysfunction of the respiratory muscles, especially the diaphragm, caused by the upper abdominal surgery is a major cause of postoperative pulmonary complications, such as atelectasis and pneumonia. Sonografic evaluation of diaphragm is an accepted qualitative method of assessing diaphragmatic motion.
The erector spinae plane block is a paraspinal fascial plane block in which local anesthetic is administered between the erector spinae muscle and the transverse processes, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves.
According to previous studies, erector spinae plane block provide lower postoperative pain score and decrease consumption of both postoperative and intraoperative analgesia for patients undergoing Epigastric hernia repair.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Gharbia
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Tanta, Gharbia, Ägypten, 31527
- Tanta University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Fifty obese patient BMI (30-40).
- Aged (21-65) years ASA (ІΙ and ΙΙІ)
- scheduled for elective Epigastric hernia repair
Exclusion Criteria:
- Patient refusal to continue the study.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- Patients with bleeding and coagulation disorders.
- Patients with renal, hepatic, cardiac dysfunction, or spine deformities.
- Patients with cognitive disorders.
- Patients with chronic pulmonary disease.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: The erector spinae plane block group
The erector spinae plane block group: Patients will receive general anesthesia plus bilateral ultrasound guided ESP block.
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The probe should then slowly be moved laterally until the transverse process is visible.
The 100 mm, 25-gauge needle should be inserted using an in-plane approach in the cephalad to caudal direction and advanced under ultrasound guidance towards the transverse process; once the needle tip is below the erector spinae muscle, a small bolus of local anesthetic should be given.
The erector spinae muscle should be visualized, separating from the transverse process.
After aspiration the local anesthetic (20 ml of 0.25% bupivacaine was injected.
Technique was repeated on the other side.
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Placebo-Komparator: Control group
Control group (group І): Patients will receive general anesthesia alone.
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Patients in this group will receive general anesthesia alone.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Post-operative pain
Zeitfenster: 24 hours postoperatively.
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Post-operative pain will be assessed by Numeric Rating Scale at recovery room till 24 hours and if NRS˃3 morphine 3 mg will be given, total analgesics required will be recorded.
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24 hours postoperatively.
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Diaphragmatic dysfunction by physiological parameter
Zeitfenster: 24 hours postoperatively.
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After recovery, patient laid in the supine position and diaphragm movements were recorded in the B-Mode and M-Mode. The probe was positioned between the midclavicular and anterior axillary lines, in the subcostal area, so that the ultrasound beam entered the posterior third of the right hemi diaphragm perpendicularly. After correct visualization of the right hemidiaphragm by B-mode, M-mode is used to display the motion of the diaphragm. At the end of normal expiration the patient was instructed to inhale as deeply as possible. A fixed point at the edge of the image on the screen and the diaphragm margin at maximal inspiration and again at maximal expiration served as reference points between which measurements were made, with the average of three values being taken for both maximal inspiration and maximal expiration |
24 hours postoperatively.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Hypotension
Zeitfenster: 24 hours postoperatively
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defined as decrease blood pressure more than 20% of base line It was treated with rapid IV fluid infusion (100ml over 1 minutes) and bolus ephedrine 5-15 mg if needed.
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24 hours postoperatively
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Bradycardia
Zeitfenster: 24 hours postoperatively
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Bradycardia (heart rate less than 60 beats /minute) was treated with atropine 0.01mg/ kg
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24 hours postoperatively
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
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
- 34579/3/21
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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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