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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraperitoneal (IP) group | Active Comparator | 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 |
|
| Intravenous (IV) group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraperitoneal Lignocaine | Drug | Patients will receive 100 ml of 0.2% lignocaine |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stress response in the form of Total Leucocyte Count (TLC) and C- reactive protein (CRP) | Blood will be analyzed for TLC and CRP preoperatively and 48 hours postoperatively to assess the stress response | Preoperatively and 48 hours Postoperatively |
| Respiratory Function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Sarath Chandra Sistla, M.S., | Jawaharlal Institute of Postgraduate Medical Education & Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, JIPMER | Puducherry | Puducherry | 605006 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16121879 | Background | Jabbour-Khoury SI, Dabbous AS, Gerges FJ, Azar MS, Ayoub CM, Khoury GS. Intraperitoneal and intravenous routes for pain relief in laparoscopic cholecystectomy. JSLS. 2005 Jul-Sep;9(3):316-21. |
| Label | URL |
|---|---|
| Pubmed site | View source |
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| Intravenous Lignocaine | Drug | 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 |
|
|
| 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 |
Respiratory function will be assessed by measuring the peak expiratory flow rate (PEFR)at the above mentioned time frames. |
| Preoperatively and 48 hours Postoperatively |
| Return of bowel activity | This will be assessed by asking the time at which the patient perceives the first bowel movement and also the time for passage of flatus post surgery. | upto to 48 hours |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D015775 | Fractures, Stress |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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