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

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ClinicalTrials.gov Identifier: NCT03221998
Recruitment Status : Not yet recruiting
First Posted : July 19, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Yair Binyamin MD, 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

Condition or disease Intervention/treatment Phase
Obesity, Morbid Drug: IV paracetamol Drug: IV saline (NaCl 0.9 %) Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain and Cytokines Levels Following Laparoscopic Sleeve Gastrectomy
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: 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
Drug: IV paracetamol
100 gram paracetamol infusion for moderate pain management
Other Name: Perfalgan infusion (paracetamol)

Placebo Comparator: IV saline (NaCl 0.9 %)
Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative
Drug: IV saline (NaCl 0.9 %)
100 ml of Normal Saline (IV NaCl 0.9 %) as placebo
Other Name: Normal Saline




Primary Outcome Measures :
  1. measuring of Visual Analogue pain Scale, [ Time Frame: up to 48 hours after surgery ]
    Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration

  2. measuring of Cytokine levels [ Time Frame: 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 :
  1. Total consumption of opiates after surgery [ Time Frame: up to 72 hours after surgery ]
    post - operative opioid consumption in manner of dosage and frequency in ward

  2. Respiratory post-operative complication while in ward [ Time Frame: up to 72 hours after surgery ]
    Respiratory complication (need of respiratory support, need of intensive care unit hospitalization)

  3. septic post-operative complication while in ward [ Time Frame: up to 72 hours after surgery ]
    development of fever above 38° C

  4. Cardiovascular post-operative complication while in ward [ Time Frame: up to 72 hours after surgery ]
    Cardiovascular complication (hemodynamic instability, inotropic support )

  5. Gastrointestinal post-operative complication while in ward [ Time Frame: up to 72 hours after surgery ]
    Gastrointestinal complaints as nausea and vomiting, need to use antiemetic drug

  6. urinary trak post-operative complication while in ward [ Time Frame: up to 72 hours after surgery ]
    Incidence of urinary retention and need for catheterization

  7. post-operative pruritus while in ward [ Time Frame: up to 72 hours after surgery ]
    Pruritus

  8. post-operative hospitalization [ Time Frame: up to one week after surgery ]
    length of hospital stay by number of days

  9. Respiratory post-operative complication while recovering in post anesthesia care unit [ Time Frame: up to 5 hours after surgery ]
    Respiratory complication need of respiratory support, need of intensive care unit hospitalization)

  10. septic post-operative complication while recovering in post anesthesia care unit [ Time Frame: up to 5 hours after surgery ]
    Development of fever above 38° C

  11. Cardiovascular post-operative complication while recovering in post anesthesia care unit [ Time Frame: up to 5 hours after surgery ]
    Cardiovascular complication (hemodynamic instability, inotropic support )

  12. Gastrointestinal post-operative complication while recovering in post anesthesia care unit [ Time Frame: up to 5 hours after surgery ]
    Gastrointestinal complication as nausea and vomiting, need to use antiemetic drugs

  13. urinary retention post-operative complication while recovering in post anesthesia care unit [ Time Frame: up to 5 hours after surgery ]
    incience of urinary retention and need for catheterization

  14. post-operative pruritus while recovering in post anesthesia care unit [ Time Frame: up to 5 hours after surgery ]
    Pruritus

  15. post-operative stay in post anesthesia care unit [ Time Frame: up to 5 hours after surgery ]
    length of post anesthesia care unit stay by number of hours



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221998


Contacts
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Contact: Yair Binyamin, MD +972586963871 Yairben1@gmail.com
Contact: Yair Yaish Reina, MD +972545442655 yair0026@gmail.com

Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Study Director: Michael Semionov, MD Soroka University Medical Center-Department of Anesthesiology
Study Chair: Alexander Zlotnic, PhdMD Soroka University Medical Center-Department of Anesthesiology
Principal Investigator: Yair Binyamin, MD Soroka University Medical Center-Department of Anesthesiology
Principal Investigator: Yair Yaish Reina, MD Soroka University Medical Center-Department of Anesthesiology

Publications of Results:

Other Publications:
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Responsible Party: Yair Binyamin MD, principal lnvestigator, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT03221998     History of Changes
Other Study ID Numbers: sor17ybyrctil
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yair Binyamin MD, Soroka University Medical Center:
morbidly obese
,elective sleeve
gastrectomy
paracetamol
IV Perfelgan
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics