Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain

Study Overview
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Brief Summary
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This study will evaluate two different analgesic regimen used for acute postoperative pain.

Detailed Description
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Laparoscopic cholecystectomy is a type of surgery that causes moderate postoperative pain. Paracetamol and non-steroid anti-inflammatory analgesics plus opioids are the mainstay treatment options of the moderate postoperative pain. These drugs are the most common used analgesics to ameliorate this type of pain and to reduce the consumption of opioids and their side effects. Ibuprofen is a well-known anti-inflammatory drug and has been used as an oral formula for a long time. Few studies using its new intravenous formula had been conducted to evaluate its effectiveness for mixed type of surgeries . However, its intravenous formula has not been studied for laparoscopic cholecystectomy. Therefore, this study will compare the effects of postoperative analgesic potencies of preemptive intravenous paracetamol and ibuprofen in patients undergoing laparoscopic cholecystectomy.

Official Title
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Comparison of the Postoperative Analgesia Effectiveness of Preemptive Intravenous Ibuprofen and Paracetamol in Patients Undergoing Laparoscopic Cholecystectomy

Conditions
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Acute Pain, Postoperative Pain

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Ibuprofen 800 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist Functional Status 1-2 Body mass index smaller than 30 Undergoing laparoscopic cholecystectomy Age between 18-60 years Exclusion Criteria: Age under 18, above 60 Weight under 40 kg Body mass index above 30 Contraindication for opioid and non-steroid anti-inflammatory drug usage Allergy against paracetamol, opioids and anti-inflammatory drugs Peptic ulcer Tendency to bleeding Pregnancy or breast feeding Moderate or severe renal, hepatic or cardiac insufficiency Coronary artery disease Asthma

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracetamol<br>Paracetamol (Paracerol) 1 gram will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours. | Drug: Paracetamol<br>* The first dose of 1 gr intravenous paracetamol will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.<br>|
| Active Comparator: Ibuprofen<br>Ibuprofen (Intrafen) 800 mg will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours. | Drug: Ibuprofen 800 mg<br>* The first dose of 800 mg intravenous ibuprofen will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | Total morphine consumption during the 24 hours of early postoperative period | The first 24 hours after the completion of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS scores | VAS scores at rest, at movement, at cough will be evaluated during the first 24 hours of early postoperative period | The first 24 hours after the completion of the surgery | 
| Morphine side effects | Morphine side effects such as nausea, vomiting, pruritus, constipation, urinary retention will be evaluated during the first 24 hours of early postoperative period | The first 24 hours after the completion of the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ibuprofen, Paracetamol, Laparoscopic cholecystectomy, Morphine, Visual analog scale