The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain

Study Overview
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Brief Summary
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This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity

Detailed Description
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All adult consecutive patients admitted to surgical departments for laparoscopic sleeve gastrectomy will be enrolled prospectively. For the purposes of the current study we want to determine how much paracetamol (acetaminophen) can reduce the cytokines levels in these patients The study enrollment period is planned to be a year. The follow-up period for each patient will be until discharge from the hospital.

Official Title
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The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain and Cytokines Levels Following Laparoscopic Sleeve Gastrectomy

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Drug: IV paracetamol
* Drug: IV saline (NaCl 0.9 %)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Patients admitted for laparoscopic sleeve gastrectomy Elective surgery BMI > 40 American Society of Anesthesiology Classification: 1-2 Exclusion Criteria: Patients' refusal to participate in the study Patients unable to give an informed consent Pregnancy Emergency surgery Patient with known allergy to paracetamol Patient with hepatic failure international normalized ratio >1.7 Albumin<3.5g/Dl Bilirubin >2mg/dL Patient with fever > 37.5 ° C Patient with hemoglobin < 8 Patients chronically treated with steroids or steroid-treated patients over a month in the year preceding surgery. Drug addict

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Interventional Model Description: This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV paracetamol<br>Patients in the first group will receive in the operating room before surgery 1 gram (100 ml) of intravenous paracetamol ( IV paracetamol) for 15 minutes intraoperative | Drug: IV paracetamol<br>* 100 gram paracetamol infusion for moderate pain management<br>* Other names: Perfalgan infusion (paracetamol);|
| Placebo Comparator: IV saline (NaCl 0.9 %)<br>Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative | Drug: IV saline (NaCl 0.9 %)<br>* 100 ml of Normal Saline (IV NaCl 0.9 %) as placebo<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring of Visual Analogue pain Scale, | Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration | up to 48 hours after surgery | 
| measuring of Cytokine levels | measuring of Cytokine levels in comparison of timing of paracetamol administration , as a predictor for inflammatory mediators released in response to noxious stimuli | up to 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total consumption of opiates after surgery | post - operative opioid consumption in manner of dosage and frequency in ward | up to 72 hours after surgery | 
| Respiratory post-operative complication while in ward | Respiratory complication (need of respiratory support, need of intensive care unit hospitalization) | up to 72 hours after surgery | 
| septic post-operative complication while in ward | development of fever above 38° C | up to 72 hours after surgery | 
| Cardiovascular post-operative complication while in ward | Cardiovascular complication (hemodynamic instability, inotropic support ) | up to 72 hours after surgery | 
| Gastrointestinal post-operative complication while in ward | Gastrointestinal complaints as nausea and vomiting, need to use antiemetic drug | up to 72 hours after surgery | 
| urinary trak post-operative complication while in ward | Incidence of urinary retention and need for catheterization | up to 72 hours after surgery | 
| post-operative pruritus while in ward | Pruritus | up to 72 hours after surgery | 
| post-operative hospitalization | length of hospital stay by number of days | up to one week after surgery | 
| Respiratory post-operative complication while recovering in post anesthesia care unit | Respiratory complication need of respiratory support, need of intensive care unit hospitalization) | up to 5 hours after surgery | 
| septic post-operative complication while recovering in post anesthesia care unit | Development of fever above 38° C | up to 5 hours after surgery | 
| Cardiovascular post-operative complication while recovering in post anesthesia care unit | Cardiovascular complication (hemodynamic instability, inotropic support ) | up to 5 hours after surgery | 
| Gastrointestinal post-operative complication while recovering in post anesthesia care unit | Gastrointestinal complication as nausea and vomiting, need to use antiemetic drugs | up to 5 hours after surgery | 
| urinary retention post-operative complication while recovering in post anesthesia care unit | incience of urinary retention and need for catheterization | up to 5 hours after surgery | 
| post-operative pruritus while recovering in post anesthesia care unit | Pruritus | up to 5 hours after surgery | 
| post-operative stay in post anesthesia care unit | length of post anesthesia care unit stay by number of hours | up to 5 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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morbidly obese, ,elective sleeve, gastrectomy, paracetamol, IV Perfelgan