Erector Spinae Plane Block Versus Rectus Sheath Block til postoperativ analgesi efter supraumbilical kirurgi
Er Erector Spinae Plane Block mere effektiv end rectus skedeblok til postoperativ analgesi efter supraumbilical kirurgi hos voksne patienter
Objectives: To compare the effectiveness of erector spinae plane block (ESPB) and rectus sheath block (RSB) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes.
Background: Supraumbilical surgery for hernia repair is the second-most-popular after surgical inguinal hernia repair and is accompanied by moderate to severe postoperative pain, so patients always require large doses of opioids within the first postoperative day. Because opioids have several adverse effects such as drowsiness, pruritus, nausea, and vomiting, regional analgesic techniques are an essential component of postoperative opioid-sparing analgesia. Previous studies have shown that regional analgesic techniques after abdominal wall surgeries can be an essential element of a postoperative pain management strategy with minimal adverse effects and hemodynamic responses.
ESPB provides both somatic and visceral analgesia to the abdominal wall, through the blockade of the anterior rami of spinal nerves and the rami communicants involving sympathetic nerve fibers. RSB provides analgesia to the anterior abdominal wall from the xiphoid process to the symphysis pubis, through the blockade of the anterior rami of the 7th to 12th intercostal nerves. The dermatomal distribution of ESPB and RSB makes them ideal regional analgesic techniques after abdominal surgery, and to our knowledge, there were no previous trials that studied the difference between them.
Patients and Methods: This was a prospective, randomized (1:1), double-blind clinical trial on 60 patients scheduled for elective supraumbilical surgery under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group E; general anesthesia with postoperative bilateral ultrasound-guided ESPB, whereas in group R; general anesthesia with postoperative bilateral ultrasound-guided RSB.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ahmed M Shaat, MD
- Telefonnummer: 00201223482709
- E-mail: ahmedshaat99@gmail.com
Studiesteder
-
-
El-Beheira
-
Damanhūr, El-Beheira, Egypten
- Rekruttering
- Damanhour Teaching Hospital
-
Kontakt:
- Ahmed M Shaat, MD
- Telefonnummer: 00201223482709
- E-mail: ahmedshaat99@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) < 35 kg/m²
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status > II
- Age < 21 years or > 60 years
- Body Mass Index (BMI) ≥ 35
- Local infection at the puncture site
- Altered mental status
- Pregnant women
- Allergy to study drugs
- Chronic pain
- Coagulation abnormalities or on anticoagulants
- Severe hepatic or kidney disease
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group E (n=30)
Erector Spinae Plane Block |
Postoperative Bilateral Ultrasound-guided ESPB |
|
Aktiv komparator: Group R (n=30)
Rectus Sheath Block |
Postoperative Bilateral Ultrasound-guided RSB |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
Tidsramme: 24 hours after block performance
|
The time interval between the block performance and the first request of postoperative analgesia |
24 hours after block performance
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
Tidsramme: 24 hours after block performance
|
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (30 minutes, 1h, 6h, 12h, 18h, 24h) after block performance |
24 hours after block performance
|
|
Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
Tidsramme: 24 hours after block performance
|
The total dose of the rescue analgesic consumed in the first 24 hours after block performance |
24 hours after block performance
|
|
Number of participants and Rate of Postoperative Complications
Tidsramme: 24 hours after block performance
|
Number of participants and Rate of: Nausea, Vomiting, Hematoma formation, Bowel perforation, and Pneumothorax |
24 hours after block performance
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ahmed M Shaat, MD, Damanhour Teaching Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DTH: 21004
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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