Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy

Study Overview
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Brief Summary
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This study is aimed to determine the post operative pain after laparoscopic cholecystectomy by dividing patients into three different group. Group A will receive lidocaine 2mg/kg bolus at induction followed by 1.5mg/kg/hr infusion. Group B will receive bilateral subcostal TAP block with 0.375% 20ml Ropivicaine on each side. Group C will not receive any additional pain regime apart from the routine intraoperative analgesics. Pain score will be assessed post operatively for 24 hours at regular intervals using visual analog score.

Official Title
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Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Lidocaine IV
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age group (18-65) Undergoing elective Laproscopic Cholecystectomy ASA status I or II Exclusion Criteria: Participation in any other trial Known hypersensitivity to study medications Chronic Opioid used Seizure disorder

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine Group<br>After induction of anaesthesia, a bolus of 2mg/kg intravenous lidocaine will be given followed by Lidocaine infusion at the rate of 1.5 mg/kg/hour which will be stopped at the end of surgery. | Drug: Lidocaine IV<br>* Bolus and infusion of lidocaine will be administered<br>|
| Experimental: TAP group<br>After completion of procedure and before extubation, bilateral ultrasound guided subcoastal transversus abdominis plane (TAP) block will be performed by the primary anaesthetist. After taking aseptic measures, with patient in supine position a high frequency (6-13 MHz) linear ultrasound probe will be placed obliquely just inferior to the costal margin over the anterior abdominal wall. With the help of a 21G or 22G, 100 mm needle, 20 ml of 0.375% Ropivacaine will be injected between rectus sheath and fascia of transversus abdominis muscle, bilaterally. | Drug: Ropivacaine<br>* Bilateral TAP block will be given to these patients<br>|
| No Intervention: Control group<br>No additional intervention will be given to this group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain) | On arrival in PACU (0 hours) | 
| Pain score | Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain) | At 2 hours | 
| Pain score | Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain) | At 4 hours | 
| Pain score | Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain) | At 6 hours | 
| Pain score | Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain) | At 12 hours | 
| Pain Score | Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain) | At 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative nausea and vomiting | Nausea and vomiting score would be assess using Bellville scoring system (0: No nausea or vomiting, 1: nausea, 2: nausea and belching, 3: vomiting) | On arrival, At 2 hours, 4 hours, 6 hours, 12 hours and 24 hours | 
| Patient Satisfaction | Patient satisfaction will be assessed on Likert Scale (Completely Disagree, Disagree, Neutral, Agree, Completely Agree) | At 24 hours or discharge |