Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Comparison of the Analgesic Effects of Local Anesthetic Infiltration and Ultrasound-Guided Rectus Sheath Block in Laparoscopic Cholecystectomy Operations: A Prospective Randomized Controlled Study
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Laparoscopic cholecystectomy is a very commonly performed and painful surgical procedure. The etiology of pain is complex and commonly includes pain related to trocar insertion sites, pain secondary to carbon dioxide insufflation, visceral pain, and shoulder pain. Various analgesic medications and regional anesthesia techniques are used for postoperative pain management. Abdominal wall blocks are frequently utilized to reduce opioid-related adverse effects.
Rectus sheath block is a regional anesthesia technique that blocks the anterior cutaneous branches of the lower thoracic nerves (T7-T12) and is used for analgesia in laparoscopic surgeries. Several studies have demonstrated that local anesthetic infiltration provides effective analgesia in laparoscopic cholecystectomy. Although rectus sheath block is an old technique traditionally used in midline surgeries, its analgesic use in laparoscopic procedures has increased in recent years.
In this prospective randomized clinical trial, we aimed to compare the effects of Local Anesthetic Infiltration and Rectus Sheath Block on opioid consumption and pain scores in laparoscopic gallbladder surgery.
To compare the effects of Local Anesthetic Infiltration and Rectus Sheath Block on opioid consumption and pain scores in laparoscopic gallbladder surgery.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: MUSTAFA ALTINAY
- Telefonnummer: 05333914422
- E-post: m_altinay@yahoo.com
Studer Kontakt Backup
- Navn: LEYLA KILINC
- Telefonnummer: +90 532 417 02 44
- E-post: leylaturkoglu@hotmail.com
Studiesteder
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Istanbul, Tyrkia (Türkiye), 34371
- Sisli Hamidiye Etfal Training Hospital
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Ta kontakt med:
- MUSTAFA ALTINAY
- Telefonnummer: 05333914422
- E-post: m_altinay@yahoo.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- ASA (American Society of Anesthesiologists) class I-II patients
- Patients aged between 18 and 65 years
- Patients undergoing laparoscopic cholecystectomy surgery
Exclusion Criteria:
- ASA class III-IV patients
- Patients undergoing emergency surgery
- Relatives of patients who do not provide consent
- Presence of chronic pain
- Chronic opioid use
- Presence of local anesthetic allergy
- Ibuprofen allergy
- Paracetamol allergy
- Presence of infection at the block site
- Coagulopathy
- Increased intracranial pressure
- Pre-existing neurological deficit
- Severe organ failure
- Mental retardation
- Anatomical deformity
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: GROUP RSB
Rectus Sheath Block: After completion of the operation, during the surgical closure phase, bilateral rectus sheath block will be performed. A linear ultrasound probe will be placed transversely over the umbilicus and 1 cm lateral to it. After visualization of the rectus abdominis muscle and posterior rectus sheath, a 22-Gauge 80 mm block needle (Braun Stimuplex Ultra-360, Melsungen, Germany) will be advanced from lateral to medial using the in-plane technique. Following hydrodissection with 1 mL saline between the rectus muscle and posterior sheath and confirmation of appropriate spread, 20 mL local anesthetic (0.25% bupivacaine) will be administered with intermittent negative aspiration. |
After completion of the operation, during the surgical closure phase, bilateral rectus sheath block will be performed.
A linear ultrasound probe will be placed transversely over the umbilicus and 1 cm lateral to it.
After visualization of the rectus abdominis muscle and posterior rectus sheath, a 22-Gauge 80 mm block needle (Braun Stimuplex Ultra-360, Melsungen, Germany) will be advanced from lateral to medial using the in-plane technique.
Following hydrodissection with 1 mL saline between the rectus muscle and posterior sheath and confirmation of appropriate spread, 20 mL local anesthetic (0.25% bupivacaine) will be administered with intermittent negative aspiration.
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Aktiv komparator: GROUP LAI
Local Anesthetic Infiltration: At the end of the operation, the surgeon will infiltrate 5 mL local anesthetic (0.5% bupivacaine) subcutaneously into each of the four trocar insertion sites. |
At the end of the operation, the surgeon will infiltrate 5 mL local anesthetic (0.5% bupivacaine) subcutaneously into each of the four trocar insertion sites.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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NRS Score
Tidsramme: Pain scores will be assessed and recorded at postoperative 0, 1, 4, 12, and 24 hours.
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Postoperative pain assessment will be performed using the Numeric Rating Scale (NRS).
The NRS is a scale in which patients rate their pain intensity numerically from 0 (no pain) to 10 (worst imaginable pain).
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Pain scores will be assessed and recorded at postoperative 0, 1, 4, 12, and 24 hours.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Opioid Consumption
Tidsramme: 24 hour
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Postoperative opioid consumption will be evaluated using intravenous patient-controlled analgesia (IV PCA) over 24 hours.
PCA will be set in bolus-only mode (10 mg tramadol), without continuous infusion.
Patients will be educated preoperatively regarding PCA use and instructed to administer boluses in case of pain.
At the end of 24 hours, total opioid consumption will be recorded from the device data, and the time to first bolus administration (time to first analgesic requirement) will also be evaluated.
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24 hour
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Adverse Effects
Tidsramme: 24 hour
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Adverse effects such as hypotension, bradycardia, nausea, vomiting, and local anesthetic systemic toxicity (LAST) occurring within the first 24 postoperative hours will be monitored and recorded.
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24 hour
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: LEYLA KILINC, şişli etfal eğitim araştırma hastanesi
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
- zeynep-1
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