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

Overview

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

Full Title of Study: “The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain and Cytokines Levels Following Laparoscopic Sleeve Gastrectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2019

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.

Interventions

  • Drug: IV paracetamol
    • 100 gram paracetamol infusion for moderate pain management
  • Drug: IV saline (NaCl 0.9 %)
    • 100 ml of Normal Saline (IV NaCl 0.9 %) as placebo

Arms, Groups and Cohorts

  • 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
  • Placebo Comparator: IV saline (NaCl 0.9 %)
    • Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

  • 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
  • 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)
  • septic post-operative complication while in ward
    • Time Frame: up to 72 hours after surgery
    • development of fever above 38° C
  • Cardiovascular post-operative complication while in ward
    • Time Frame: up to 72 hours after surgery
    • Cardiovascular complication (hemodynamic instability, inotropic support )
  • 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
  • urinary trak post-operative complication while in ward
    • Time Frame: up to 72 hours after surgery
    • Incidence of urinary retention and need for catheterization
  • post-operative pruritus while in ward
    • Time Frame: up to 72 hours after surgery
    • Pruritus
  • post-operative hospitalization
    • Time Frame: up to one week after surgery
    • length of hospital stay by number of days
  • 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)
  • 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
  • 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 )
  • 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
  • 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
  • post-operative pruritus while recovering in post anesthesia care unit
    • Time Frame: up to 5 hours after surgery
    • Pruritus
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Soroka University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yair Binyamin MD, principal lnvestigator – Soroka University Medical Center
  • Overall Official(s)
    • Michael Semionov, MD, Study Director, Soroka University Medical Center-Department of Anesthesiology
    • Alexander Zlotnic, PhdMD, Study Chair, Soroka University Medical Center-Department of Anesthesiology
    • Yair Binyamin, MD, Principal Investigator, Soroka University Medical Center-Department of Anesthesiology
    • Yair Yaish Reina, MD, Principal Investigator, Soroka University Medical Center-Department of Anesthesiology
  • Overall Contact(s)
    • Yair Binyamin, MD, +972586963871, Yairben1@gmail.com

References

Ruiz-Tovar J, Muñoz JL, Gonzalez J, Zubiaga L, García A, Jimenez M, Ferrigni C, Durán M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13.

Citations Reporting on Results

Salihoglu T, Salihoglu Z, Zengin AK, Taskin M, Colakoglu N, Babazade R. The impacts of super obesity versus morbid obesity on respiratory mechanics and simple hemodynamic parameters during bariatric surgery. Obes Surg. 2013 Mar;23(3):379-83. doi: 10.1007/s11695-012-0783-0.

Rieg AD, Stoppe C, Rossaint R, Coburn M, Hein M, Schälte G. [EzPAP® therapy of postoperative hypoxemia in the recovery room : experiences with the new compact system of end-expiratory positive airway pressure]. Anaesthesist. 2012 Oct;61(10):867-74. doi: 10.1007/s00101-012-2083-4. Epub 2012 Sep 27. German.

Cullen A, Ferguson A. Perioperative management of the severely obese patient: a selective pathophysiological review. Can J Anaesth. 2012 Oct;59(10):974-96. Epub 2012 Jul 26. Review.

Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458. Review.

Macintyre PE, Loadsman JA, Scott DA. Opioids, ventilation and acute pain management. Anaesth Intensive Care. 2011 Jul;39(4):545-58. Review.

Schug SA, Raymann A. Postoperative pain management of the obese patient. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):73-81. Review.

Daszkiewicz A, Wyleżoł M. Postoperative analgesia in a morbidly obese patient with chronic renal failure. Anestezjol Intens Ter. 2010 Oct-Dec;42(4):197-200.

Ahmed S, Morrow E, Morton J. Perioperative considerations when operating on the very obese: tricks of the trade. Minerva Chir. 2010 Dec;65(6):667-75.

Pelosi P, Gregoretti C. Perioperative management of obese patients. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):211-25. Review.

Hans GA, Lauwick S, Kaba A, Brichant JF, Joris JL. Postoperative respiratory problems in morbidly obese patients. Acta Anaesthesiol Belg. 2009;60(3):169-75. Review.

Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356-61.

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.

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