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Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Epigastric Hernia

25. august 2022 opdateret af: Asmaa Ragab Mohamed, Tanta University

Effect of Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Obese Patients Undergoing Epigastric Hernia Repair

The aim of this study is to assess the efficacy of ultrasound guided erector Spinae plane block on postoperative pain score and diaphragmatic dysfunction in obese patients undergoing Epigastric hernia repair.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Egypten
    • Gharbia
      • Tanta, Gharbia, Egypten, 31527
        • Tanta University

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

21 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: The erector spinae plane block group
The erector spinae plane block group: Patients will receive general anesthesia plus bilateral ultrasound guided ESP block.
Procedure: The erector spinae plane block group
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.
Placebo komparator: Control group
Control group (group І): Patients will receive general anesthesia alone.
Procedure: Control group
Patients in this group will receive general anesthesia alone.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-operative pain
Tidsramme: 24 hours postoperatively.
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.
24 hours postoperatively.
Diaphragmatic dysfunction by physiological parameter
Tidsramme: 24 hours postoperatively.

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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hypotension
Tidsramme: 24 hours postoperatively
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.
24 hours postoperatively
Bradycardia
Tidsramme: 24 hours postoperatively
Bradycardia (heart rate less than 60 beats /minute) was treated with atropine 0.01mg/ kg
24 hours postoperatively

Samarbejdspartnere og efterforskere

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Sponsor

Tanta 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. juli 2021

Primær færdiggørelse (Faktiske)

15. juli 2022

Studieafslutning (Faktiske)

30. juli 2022

Datoer for studieregistrering

Først indsendt

20. august 2022

Først indsendt, der opfyldte QC-kriterier

25. august 2022

Først opslået (Faktiske)

26. august 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 34579/3/21

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