This study will define the postoperative analgesic effect of ultrasound-guided bilateral External Oblique İntercostal (EOI) Plane Block and compare the control group in patients undergoing laparoscopic cholecystectomy. The aim of this study is to compare postoperative opioid consumption of EOI plane block versus control group. It is hypothesized that postoperative opioid use will be less in patients with EOI plane block than in patients who only receive routine multimodal analgesia.
Laparoscopy is a minimally invasive procedure, but postoperative pain is still the most common symptom after laparoscopic cholecystectomy (LC). Regional blocks used in addition to multimodal analgesia for postoperative pain after LC usually block the anterior branches of the intercostal nerves. After it was suggested by Hamilton et al. in 2018 that it could block the lateral cutaneous branches between T7-T11 intercostal nerve by administering local anesthetic to the thoracic facial plane and could be used in lateral abdominal surgeries, the EOI plane block has become a block that can be used for analgesic purposes in upper and lateral abdominal surgeries. Blocking the anterior and lateral branches together may produce analgesia in a wider area, resulting in less postoperative opioid consumption. This study will be conducted as a single-center, prospective, randomized trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, EOI Plane Block will be performed under ultrasound guidance after administering general anesthesia and prior to the skin incision. An anesthesiologist who performed blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative opioid consumption,pain scores, nausea and vomiting, antiemetic use, and Quality of Recovery score will be blinded to group assignment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
External Oblique İntercostal (EOI) Plane Block will be provided for postoperative pain for Laparoscopic Cholecystectomy with Bupivacaine. And patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.
Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol for Laparoscopic Cholecystectomy.
Karaman Taining and Research Hospital
Karaman, Turkey (Türkiye)
Opioid consumption
If NRS score of the patient is equal or over 4, IV 50 mg tramadol will be applied as a rescue analgesic.
Time frame: Postoperative 24 hours
Numerical Rating Scale scores
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 hours
Time to first rescue analgesic
The time for administration of first rescue analgesic.
Time frame: Postoperative 24 hours
Adverse events
Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.
Time frame: Postoperative 24 hours
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 hours
Sedation score
Sedation level of the patients will be assessed on a 4-point scale (0=alert, 1=sleepy, easy to arouse verbally, 2= drowsy, 3=does not open eyes to verbal commands) at postoperative 15th,30th and 60th minute, second, 6th, 12th and 24th hour.
Time frame: Postoperative 24 hour
Quality of recovery levels between groups by using QoR-15 questionnaire
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Enrollment
80
A 15-parameter Quality of Recovery score (QoR-15) has been recommended as the optimum tool to evaluate overall patient-centers measures of recovery after surgery, including pain. It is a questionnaire that is given to patients to do postoperatively and is scored from 0 to 150 where 150 indicates that the patient has had an excellent recovery QoR-15 score will be recorded on the morning of operation and at the postoperative 24th hour.
Time frame: Postoperative 24th hour