US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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To compare the efficacy of USG-guided bilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in providing post-operative analgesia.

Official Title
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Ultrasound Guided External Oblique Intercostal (EOI) Block Versus Erector Spinae Plane Block (ESPB) for Postoperative Analgesia in Laparoscopic Cholecystectomy

Conditions
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Postoperative Pain

Intervention / Treatment
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* Other: External oblique intercostal (EOI) block
* Other: Erector spinae plane block (ESPB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2, patients with the American Society of Anesthesiologists (ASA) physical status I/II, 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: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: External oblique intercostal (EOI) block<br> | Other: External oblique intercostal (EOI) block<br>* A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. 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>|
| Active Comparator: Erector spinae plane block (ESPB)<br> | Other: Erector spinae plane block (ESPB)<br>* 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. 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 Local Anesthetic 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nalbuphine consumption in mg equivalent to morphine dose. | mg | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) at rest and when coughing | 11-point scale where 0=no pain and 10=worst pain | at 1, 2,4 , 8, 16 and 24 hours postoperatively | 
| Analgesic drug consumption other than nalbuphine | in mg | 24 hours postoperatively | 
| Heart Rate | beats /min | Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery | 
| Mean Arterial Pressure | mmHg | Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery | 
| Incidence of Postoperative nausea & vomiting (PONV) | Number of patients developing PONV | 24 hours postoperatively | 
| Shoulder pain | Number of patients developing Shoulder pain | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholecystectomy, EOI block, ESP block