Comparison of Analgesic Efficacy of US Guided ESP Block With Port Site Infiltration Following Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.

Official Title
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Comparison of Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block With Port Site Infiltration Following Laparoscopic Cholecystectomy

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Erector spinae plane block
* Procedure: Port site infiltration
* Device: Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)
* Drug: Bupivacaine 0.5%
* Drug: Lidocaine 2%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with the American Society of Anesthesiologists (ASA) physical status I/II, Age between 18 and 60 years with a body mass index (BMI) of 18-35 kg/m2, Patients scheduled for elective laparoscopic cholecystectomy. Exclusion Criteria: Allergy to local anaesthetics, Infection at the site of injection, •, Coagulopathy, Chronic pain syndromes, Prolonged opioid medication, Patients who received any analgesic 24 h before surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erector spinae plane block<br>ultrasound guided ESP Block after anaesthesia induction | Procedure: Erector spinae plane block<br>* Patients will be placed on their right side. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10-cm needle will be inserted using an in-plane approach in a cranial to caudal direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.<br>* Other names: ESP block;Device: Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)<br>* Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.<br>Drug: Bupivacaine 0.5%<br>* Bupivacaine 0.5% will be included in the injected LA mixture.<br>Drug: Lidocaine 2%<br>* Lidocaine 2% will be included in the injected LA mixture.<br>|
| Active Comparator: Port site infiltration technique<br>After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites | Procedure: Port site infiltration<br>* After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of the LA mixture. The volume will be divided equally between port sites. A total of four ports-supraumbilical, subxiphoid and two ports in the right subcostal area at mid-clavicular and anterior axillary line will be made.<br>Drug: Bupivacaine 0.5%<br>* Bupivacaine 0.5% will be included in the injected LA mixture.<br>Drug: Lidocaine 2%<br>* Lidocaine 2% will be included in the injected LA mixture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative opioid consumption. | Nalbuphine consumption in mg.(equivalent to morphine dose) | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores;Numerical Rating Scale (NRS) at rest and when coughing | The NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which a respondent selects a whole number (0-10 integers). | at 1, 2,4 , 8, 16 and 24 hours postoperatively. | 
| •Cumulative postoperative analgesic consumption | Analgesic drug consumption other than nalbuphine in mg. | 24 hours postoperatively | 
| •Heart Rate (HR) | Heart Rate in beats /min | Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery | 
| •Mean Arterial Pressure (MAP) | Mean Arterial Pressure in mmHg | Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery | 
| Incidence and severity Postoperative nausea & vomiting (PONV). | Number of patients developing PONV & PONV Score; (1) No nausea or vomiting, (2) only nausea but no vomiting, (3) single episode of vomiting or persistent nausea, and (4) two or more episodes of vomiting or severe retching. | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholecystectomy, ESP block, Port Site Infiltration