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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: MUSTAFA ALTINAY
- Telefoonnummer: 05333914422
- E-mail: m_altinay@yahoo.com
Studie Contact Back-up
- Naam: LEYLA KILINC
- Telefoonnummer: +90 532 417 02 44
- E-mail: leylaturkoglu@hotmail.com
Studie Locaties
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Istanbul, Turkije (Türkiye), 34371
- Sisli Hamidiye Etfal Training Hospital
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Contact:
- MUSTAFA ALTINAY
- Telefoonnummer: 05333914422
- E-mail: m_altinay@yahoo.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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NRS Score
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Opioid Consumption
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: LEYLA KILINC, şişli etfal eğitim araştırma hastanesi
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- zeynep-1
Informatie over medicijnen en apparaten, studiedocumenten
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