The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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The aim of this study is to assess the effect of ultrasound guided erector spinae block in control of the postoperative pain and the respiratory functions after laparoscopic cholecystectomy.

Official Title
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The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy

Conditions
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Laparoscopic Cholecystectomy, Postoperative Pain, Respiratory Function

Intervention / Treatment
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* Procedure: Bilateral Erector Spinae Block
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • American Society of Anesthesiology (ASA) physical status I-II patients who were scheduled for elective laparoscopic cholecystectomy Exclusion Criteria: Patients refusal Contraindications for regional anesthesia Alcohol or drug abuse Chronic opioid intake Patient with psychiatric disorders Use of pain killers within the 24 h before the operation Respiratory tract infection within the last 2 weeks Smoker or history of smoking Allergy to local anesthetics Respiratory and allergic diseases Cardiac disease associated with dyspnea

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erector Spinae Plane Block Group<br>Procedure: In addition to routine standard perioperative and postoperative analgesic protocol participants will recieve erector spinae block under ultrasound guidence after the strict aseptic precautions. | Procedure: Bilateral Erector Spinae Block<br>* A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. 40 ml bupivacaine/lidocaine mixture will be injected into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS).<br>|
| Sham Comparator: Control<br>Routine standard perioperative and postoperative analgesic protocol will be given. | Other: Control<br>* Standard perioperative and postoperative analgesia protocol will be given consisting of paracetamol 1 gr IV and tenoxicam 20 mg IV initiated after induction of anesthesia. At the end of the operation patients will receive meperidine 0.5 mg/kg IV before extubation. Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system, 20 minutes intervals in the first hour and at 2th, 6th, 12th and 24 th hour. For the first hour in the postoperative care unit, tramadol 50 mg IV will be given for rescue analgesia with minimum 20 minutes between doses, in patients showing a NRS ≥ 4. Paracetamol 1 g / 12 hour will be given during ward follow-up. In the ward in patients showing a NRS ≥ 4 tramadol 50 mg IV will be given for analgesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoring of postoperative pain | The primary outcome variable is Numeric Rating Scale (NRS) pain scores changes both at rest and movement. NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain). | Postoperative 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic consumption | Total opioid consumption after the operation | Postoperative 24 hour | 
| Spirometric Parameters of Respiratory Functions | Respiratory functions assessed by spirometric parameters (FEV1, FVC, FEV1/FVC, and PEFR) | Preoperative (before the surgery) and at postoperative 24th hour | 
| Number of Adverse events | Postoperative nausea and vomiting incidents at PACU and and at ward. | Postoperative 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector Spinae Block, Laparoscopy, Respiratory Function