The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain
- 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
- Age ≥18 years
- Patients admitted for laparoscopic sleeve gastrectomy
- Elective surgery
- BMI > 40
- American Society of Anesthesiology Classification: 1-2
- 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
Group Intervention Description IV paracetamol IV paracetamol 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 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
Name Time Method 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 levels up 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
Name Time Method Total consumption of opiates after surgery up 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 unit up 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 unit up to 5 hours after surgery Development of fever above 38° C
urinary trak post-operative complication while in ward up to 72 hours after surgery Incidence of urinary retention and need for catheterization
post-operative pruritus while in ward up to 72 hours after surgery Pruritus
post-operative hospitalization up to one week after surgery length of hospital stay by number of days
Respiratory post-operative complication while in ward up to 72 hours after surgery Respiratory complication (need of respiratory support, need of intensive care unit hospitalization)
septic post-operative complication while in ward up to 72 hours after surgery development of fever above 38° C
Cardiovascular post-operative complication while in ward up to 72 hours after surgery Cardiovascular complication (hemodynamic instability, inotropic support )
Gastrointestinal post-operative complication while in ward up 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 unit up 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 unit up to 5 hours after surgery Cardiovascular complication (hemodynamic instability, inotropic support )
urinary retention post-operative complication while recovering in post anesthesia care unit up to 5 hours after surgery incience of urinary retention and need for catheterization
post-operative pruritus while recovering in post anesthesia care unit up to 5 hours after surgery Pruritus
post-operative stay in post anesthesia care unit up to 5 hours after surgery length of post anesthesia care unit stay by number of hours