Clinical trial NCT03221998: The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain
Official title: The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain and Cytokines Levels Following Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Obesity, Morbid
Keywords: morbidly obese
,elective sleeve
gastrectomy
paracetamol
IV Perfelgan
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: measuring of Visual Analogue pain Scale,
timeFrame: up to 48 hours after surgery
measure: measuring of Cytokine levels
timeFrame: up to 48 hours after surgery
Secondary outcomes:
measure: Total consumption of opiates after surgery
timeFrame: up to 72 hours after surgery
measure: Respiratory post-operative complication while in ward
timeFrame: up to 72 hours after surgery
measure: septic post-operative complication while in ward
timeFrame: up to 72 hours after surgery
measure: Cardiovascular post-operative complication while in ward
timeFrame: up to 72 hours after surgery
measure: Gastrointestinal post-operative complication while in ward
timeFrame: up to 72 hours after surgery
measure: urinary trak post-operative complication while in ward
timeFrame: up to 72 hours after surgery
measure: post-operative pruritus while in ward
timeFrame: up to 72 hours after surgery
measure: post-operative hospitalization
timeFrame: up to one week after surgery
measure: Respiratory post-operative complication while recovering in post anesthesia care unit
timeFrame: up to 5 hours after surgery
measure: septic post-operative complication while recovering in post anesthesia care unit
timeFrame: up to 5 hours after surgery
measure: Cardiovascular post-operative complication while recovering in post anesthesia care unit
timeFrame: up to 5 hours after surgery
measure: Gastrointestinal post-operative complication while recovering in post anesthesia care unit
timeFrame: up to 5 hours after surgery
measure: urinary retention post-operative complication while recovering in post anesthesia care unit
timeFrame: up to 5 hours after surgery
measure: post-operative pruritus while recovering in post anesthesia care unit
timeFrame: up to 5 hours after surgery
measure: post-operative stay in post anesthesia care unit
timeFrame: up to 5 hours after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Soroka University Medical Center-Department of Anesthesiology
name: Michael Semionov, MD
role: STUDY_DIRECTOR
affiliation: Soroka University Medical Center-Department of Anesthesiology
name: Alexander Zlotnic, PhdMD
role: STUDY_CHAIR
affiliation: Soroka University Medical Center-Department of Anesthesiology
name: Yair Binyamin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka University Medical Center-Department of Anesthesiology
name: Yair Yaish Reina, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Heinrich S, Horbach T, Salleck D, Birkholz T, Irouschek A, Schmidt J. [Perioperative anaesthesiological management in 167 patients undergoing bariatric surgery]. Zentralbl Chir. 2011 Dec;136(6):604-11. doi: 10.1055/s-0031-1271382. Epub 2011 Apr 14. German.