EOIB for Laparoscopic Cholecystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
About this trial
Laparoscopic cholecystectomy, while less painful compared to conventional methods, is still a surgery that can cause significant pain for patients. Preventing postoperative pain is crucial for reducing respiratory complications, shortening hospital stays, and increasing patient satisfaction. Interfascial plane blocks have been widely used for postoperative analgesia in recent years worldwide. The External Oblique Intercostal Plane Block is one of the interfascial plane blocks used in abdominal surgeries. In our study, we aimed to compare the postoperative pain scores of patients who underwent laparoscopic cholecystectomy under general anesthesia, specifically between those who received the external oblique intercostal plane block and those who had trocar entry site infiltration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 to 65 who will be scheduled for an elective laparoscopic cholecystectomy under general anesthesia
ASA (American Society of Anesthesiologists) I-II-III
Disqualifiers
presence of coagulation disorder
infection at the injection site of the block
known allergy to local anesthetics
advanced hepatic, heart or renal failure
Trial design
Design model
Parallel
Treatments tested in this trial
ultrasound guided external oblique intercostal plane block
Deviceultrasound guided external oblique intercostal plane block
Bupivacaine injection
Drug5 ml local anesthetic for each trocar sides
paracetamol, tramadol, and ondansetron
DrugAs standard multimodal analgesia, 20 min before the end of the surgery patients will receive 1 g of paracetamol, 1-2 mg/kg of tramadol, and 4 mg of ondansetron via intravenous infusion. All patients will be recovered in the PACU, and after confirming an Aldrete score of \>9, a PCA (patient-controlled analgesia) device will be installed with morphine prepared at a dose appropriate for the patient's age. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. When patients have a Numerical Rating Scale (NRS) score is ≥ 4, 1 mg/kg iv tramadol will be administered as a rescue analgesic
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Grup E (External Oblique Intercostal Plane Block)Active comparator 2 interventions
Group B: Grup T ( Trocar entry site infiltration)Other 2 interventions
Trial outcomes
Primary outcomes
1
NRS (Numeric Rating Skore)
The primary outcome variable is Numerical Rating Scale scores both at rest and motion. A blinded anesthesiologist will assess postoperative pain during rest and motion at the postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).
Time frame
Postoperative 24 hoursSecondary outcomes
1
Opioid Consumption
First 24 hours total morphine consumption with patient controlled analgesia
Time frame
Postoperative 24 hours2
Time to first rescue analgesic
The time for administration of first rescue analgesic.
Time frame
Postoperative 24 hours3
Adverse Events
Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.
Time frame
Postoperative 24 hours4
Metoclopromide Consumption
The severity of the nausea will be assessed on a 4 -point scale (0=none 1=mild, 2=moderate 3=severe). If the patients nausea score is ≥2 the patient will receive 10 mg metoclopromide.
Time frame
Postoperative 24 hoursSponsors and contacts
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Source ClinicalTrials.gov