Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and intravenous administration of lignocaine has been used. But it is not clear from the existing literature which form of administration is more effective for pain relief. Hence this study has been undertaken with the following hypothesis : Intravenous lignocaine is superior to intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response in laparoscopic cholecystectomy.

Detailed Description
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Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and intravenous administration of lignocaine has been used. But it is not clear from the existing literature which form of administration is more effective for pain relief. Hence this study has been undertaken with the following hypothesis : Intravenous lignocaine is superior to intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response in laparoscopic cholecystectomy. In this study the effect of intraperitoneal and intravenous lignocaine will be assessed based on the postoperative pain scores, total analgesic requirement, stress response in the form of total leukocyte count, c-reactive protein levels,return of bowel activity.

Official Title
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Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy - A Randomized Clinical Trial

Conditions
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Pain, Postoperative, Analgesic Requirement, Stress Response, Return of Bowel Activity, Inadequate or Impaired Respiratory Function

Intervention / Treatment
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* Drug: Intraperitoneal Lignocaine
* Drug: Intravenous Lignocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients planned for elective laparoscopic cholecystectomy in the age group of 20 -60 years belonging to American society of anesthesiologists (ASA)score I-II Exclusion Criteria: Chronic pain diseases other than gall stone disease. Use of opioids, steroids, Non steroidal anti inflammatory drugs or alcohol. Allergy and contraindication to Lignocaine. Conversion to open cholecystectomy. Patients who do not comprehend Visual analogue scale (VAS) / patient controlled analgesia (PCA).

Ages Eligible for Study
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Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intraperitoneal (IP) group<br>Patients will receive 100 ml of 0.2% Lignocaine as intraperitoneal lignocaine irrigation in the gall bladder fossa along with a placebo of normal saline of volume equivalent to 1.5 mg/kg of intravenous lignocaine at induction and normal saline of volume equivalent to 2 mg/kg/hour of intravenous lignocaine as continuous infusion until one hour postoperatively to ensure blinding | Drug: Intraperitoneal Lignocaine<br>* Patients will receive 100 ml of 0.2% lignocaine<br>* Other names: IP Lignocaine;|
| Active Comparator: Intravenous (IV) group<br>Patients will receive 1.5mg/kg of intravenous lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lignocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding. | Drug: Intravenous Lignocaine<br>* Intravenous group patients will receive 1.5mg/kg of lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion until one hour after surgery<br>* Other names: IV lignocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain relief | Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 1 hour postoperatively. | 1 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Analgesic Requirement | Patients will get analgesia through patient controlled analgesia pump (PCA). This pump delivers Morphine for pain relief. This will be delivered at 1 mg/ml bolus dose with a lock out period of 15 minutes without any background infusion of the drug. The total requirement over a period of 24 hours will be noted. Also the time taken for the patient to take the first analgesic dose will be recorded. The total demands and the number of good demands in the PCA pump will also be recorded. | First 24 hours in the postoperative period | 
| Postoperative pain relief | Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 8 hours postoperatively | 8 hours postoperatively | 
| Postoperative pain relief | Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 24 hours postoperatively | 24 hours postoperatively | 
| Postoperative pain relief | Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 48 hours postoperatively | 48 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lignocaine, Laparoscopic cholecystectomy, Pain relief