Clinical trial NCT05536557: Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy.
Official title: Ultrasound-guided Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Keywords: Laparoscopic Cholecystectomy
Acute Postoperative Pain
Nerve block
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two group;

1. Experimental Group: Group (EOI) Plane Block ; A block needle will inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to EOI plane. The same procedure will be repeated on the contralateral side. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.
2. Sham Comparator Group:The patients will not receive any intervention. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study.

Exclusion Criteria:

* presence of coagulation disorder
* infection at the injection site of the block
* known allergy to local anesthetics
* advanced hepatic or renal failure
* can not communicate in Turkish
* history of abdominal surgery or trauma
* conversion of laparoscopic to open surgery
* consumption of any pain killers within the 24 h before the operation
* chronic opioid consumption
* pregnancy
* alcohol or drug abuse
* body mass index (BMI) ≥ 35 kg m-2.

Primary outcomes:
measure: Opioid consumption
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Numerical Rating Scale scores
timeFrame: Postoperative 24 hours
measure: Time to first rescue analgesic
timeFrame: Postoperative 24 hours
measure: Adverse events
timeFrame: Postoperative 24 hours
measure: Metoclopromide consumption
timeFrame: Postoperative 24 hours
measure: Sedation score
timeFrame: Postoperative 24 hour
measure: Quality of recovery levels between groups by using QoR-15 questionnaire
timeFrame: Postoperative 24th hour
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Taining and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Muhammet Korkusuz, MD
role: STUDY_CHAIR
References: