- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07692659
Ultrasound-Guided Parasternal/Rectus Sheath Block vs Erector Spinae Plane Block for Pain Control in Cardiac Surgery
Comparison of Ultrasound Guided Bilateral Parasternal Block With Bilateral Rectus Sheath Block Versus Ultrasound Guided Bilateral Erector Spinae Plane Block in Controlling Intra and Post-operative Pain After Cardiac Surgeries
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Optimal anesthesia in cardiac surgery requires careful management to avoid sympathetic stimulation, with analgesia being central to patient safety and recovery. Traditionally, high-dose opioids were used, but this approach delays extubation, conflicting with fast-track protocols that emphasize early extubation. Consequently, opioid-free analgesia has gained importance, employing regional techniques such as neuraxial, paravertebral, and fascial plane blocks.
Thoracic epidural analgesia (TEA) offers effective pain control and reduces perioperative cardiovascular and respiratory complications. However, its use in anticoagulated patients raises concern for epidural hematoma. Alternatives like paravertebral and fascial plane blocks provide comparable analgesia with lower risk. The erector spinae plane block (ESPB) reduces analgesic requirements, though deep blocks still pose bleeding risks.
Superficial plane blocks are therefore clinically valuable. The parasternal intercostal block-targeting anterior cutaneous branches of intercostal nerves-has emerged as a safe option for patients undergoing median sternotomy while on anticoagulant or antiplatelet therapy. Additionally, bilateral rectus sheath block can reduce chest tube insertion pain after cardiac surgery.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Walaa Y Elsabeeny, MD
- Telefonnummer: 01007798466
- E-post: walaa.elsabeeny@nci.cu.edu.eg
Studer Kontakt Backup
- Navn: Mostafa A Ibrahim, MD
- Telefonnummer: +966541227090
- E-post: MAbIbrahim@sghgroup.net
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Both sexes,
- ASA III-IV patients
- body mass index between 20- 35 kg/m2
- adult patients above 18 years old will be included in the study
Exclusion Criteria:
- Patients with global hypokinesia
- ejection fraction < 40%
- low platelet count
- coagulation impairment
- deformity in the vertebral column
- severe renal and hepatic impairment
- any known allergy to the drugs used
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Parasternal/ Rectus sheath
Patients will receive Parasternal and rectus sheath blocks; with injection of 10 ml bupivacaine 0.25% in each side after confirmation of needle position.
Both parasternal and rectus heath blocks will be performed bilaterally
|
the parasternal block will be performed parasternally at the level of fifth rib to the plane between the pectoralis major and the internal intercostal muscle.
The rectus sheath block will be performed through injection in the plane posterior to the rectus abdominis muscle and anterior to the posterior rectus sheath
|
|
Eksperimentell: Erector Spinae Plane Block
The patients will receive a bilateral ESPB with an injection of 20 ml of bupivacaine 0.25%.
|
injection above the transverse process
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Numeric rating score
Tidsramme: 24 hours
|
postoperative pain scores using Numerical Rating Scale (NRS) with 0 meaning no pain and 10 meaning the worst pain level
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
postoperative opioid consumption
Tidsramme: 24 hours
|
opioid consumption in the first 24 hours postoperatively
|
24 hours
|
|
extubation time
Tidsramme: immediate postoperative
|
time to extubate
|
immediate postoperative
|
|
first time to request analgesia
Tidsramme: 24 hours
|
first time to request opioid analgesia
|
24 hours
|
|
peri-operative hemodynamics
Tidsramme: intraoperative and 24 hours
|
incidence of hypotension, hypertension, tachycardia and bradycardia
|
intraoperative and 24 hours
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Walaa Y Elsabeeny, MD, A Professor of Anesthesia, Critical Care and Pain Management, National Cancer Institute, Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ECC-2025-64
Legemiddel- og utstyrsinformasjon, studiedokumenter
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