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

Early Phase 1
Conditions
Obesity, Morbid
Interventions
Drug: IV saline (NaCl 0.9 %)
Registration Number
NCT03221998
Lead Sponsor
Soroka University Medical Center
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
126
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
IV paracetamolIV paracetamolPatients 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
IV saline (NaCl 0.9 %)IV saline (NaCl 0.9 %)Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative
Primary Outcome Measures
NameTimeMethod
measuring of Visual Analogue pain Scale,up to 48 hours after surgery

Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration

measuring of Cytokine levelsup to 48 hours after surgery

measuring of Cytokine levels in comparison of timing of paracetamol administration , as a predictor for inflammatory mediators released in response to noxious stimuli

Secondary Outcome Measures
NameTimeMethod
Total consumption of opiates after surgeryup to 72 hours after surgery

post - operative opioid consumption in manner of dosage and frequency in ward

Gastrointestinal post-operative complication while recovering in post anesthesia care unitup to 5 hours after surgery

Gastrointestinal complication as nausea and vomiting, need to use antiemetic drugs

septic post-operative complication while recovering in post anesthesia care unitup to 5 hours after surgery

Development of fever above 38° C

urinary trak post-operative complication while in wardup to 72 hours after surgery

Incidence of urinary retention and need for catheterization

post-operative pruritus while in wardup to 72 hours after surgery

Pruritus

post-operative hospitalizationup to one week after surgery

length of hospital stay by number of days

Respiratory post-operative complication while in wardup to 72 hours after surgery

Respiratory complication (need of respiratory support, need of intensive care unit hospitalization)

septic post-operative complication while in wardup to 72 hours after surgery

development of fever above 38° C

Cardiovascular post-operative complication while in wardup to 72 hours after surgery

Cardiovascular complication (hemodynamic instability, inotropic support )

Gastrointestinal post-operative complication while in wardup to 72 hours after surgery

Gastrointestinal complaints as nausea and vomiting, need to use antiemetic drug

Respiratory post-operative complication while recovering in post anesthesia care unitup to 5 hours after surgery

Respiratory complication need of respiratory support, need of intensive care unit hospitalization)

Cardiovascular post-operative complication while recovering in post anesthesia care unitup to 5 hours after surgery

Cardiovascular complication (hemodynamic instability, inotropic support )

urinary retention post-operative complication while recovering in post anesthesia care unitup to 5 hours after surgery

incience of urinary retention and need for catheterization

post-operative pruritus while recovering in post anesthesia care unitup to 5 hours after surgery

Pruritus

post-operative stay in post anesthesia care unitup to 5 hours after surgery

length of post anesthesia care unit stay by number of hours

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