Laparoscopic Cholecystectomy Clinical Trial
Official title:
Ultrasound-guided Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Controlled Trial
Verified date | November 2022 |
Source | Karaman Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | November 24, 2022 |
Est. primary completion date | November 23, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Karaman Taining and Research Hospital | Karaman |
Lead Sponsor | Collaborator |
---|---|
Karaman Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid consumption | If NRS score of the patient is equal or over 4, IV 50 mg tramadol will be applied as a rescue analgesic. | Postoperative 24 hours | |
Secondary | 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). | Postoperative 24 hours | |
Secondary | Time to first rescue analgesic | The time for administration of first rescue analgesic. | Postoperative 24 hours | |
Secondary | Adverse events | Incidence of nausea and vomiting during postoperative 24 hour time period will be noted. | Postoperative 24 hours | |
Secondary | 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. | Postoperative 24 hours | |
Secondary | 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. | Postoperative 24 hour | |
Secondary | Quality of recovery levels between groups by using QoR-15 questionnaire | 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. | Postoperative 24th hour |
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