- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Walaa Y Elsabeeny, MD
- Telefonnummer: 01007798466
- E-post: walaa.elsabeeny@nci.cu.edu.eg
Studera Kontakt Backup
- Namn: Mostafa A Ibrahim, MD
- Telefonnummer: +966541227090
- E-post: MAbIbrahim@sghgroup.net
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Numeric rating score
Tidsram: 24 hours
|
postoperative pain scores using Numerical Rating Scale (NRS) with 0 meaning no pain and 10 meaning the worst pain level
|
24 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
postoperative opioid consumption
Tidsram: 24 hours
|
opioid consumption in the first 24 hours postoperatively
|
24 hours
|
|
extubation time
Tidsram: immediate postoperative
|
time to extubate
|
immediate postoperative
|
|
first time to request analgesia
Tidsram: 24 hours
|
first time to request opioid analgesia
|
24 hours
|
|
peri-operative hemodynamics
Tidsram: intraoperative and 24 hours
|
incidence of hypotension, hypertension, tachycardia and bradycardia
|
intraoperative and 24 hours
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Walaa Y Elsabeeny, MD, A Professor of Anesthesia, Critical Care and Pain Management, National Cancer Institute, Cairo University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ECC-2025-64
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