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

The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain and Cytokines Levels Following Laparoscopic Sleeve Gastrectomy

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

Study Overview

• Status: Unknown
• Conditions: Obesity, Morbid
• Intervention / Treatment: Drug: IV paracetamol; Drug: IV saline (NaCl 0.9 %)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Early Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measuring of Visual Analogue pain Scale,	Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration	up to 48 hours after surgery
measuring of Cytokine levels	measuring of Cytokine levels in comparison of timing of paracetamol administration , as a predictor for inflammatory mediators released in response to noxious stimuli	up to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total consumption of opiates after surgery	post - operative opioid consumption in manner of dosage and frequency in ward	up to 72 hours after surgery
Respiratory post-operative complication while in ward	Respiratory complication (need of respiratory support, need of intensive care unit hospitalization)	up to 72 hours after surgery
septic post-operative complication while in ward	development of fever above 38° C	up to 72 hours after surgery
Cardiovascular post-operative complication while in ward	Cardiovascular complication (hemodynamic instability, inotropic support )	up to 72 hours after surgery
Gastrointestinal post-operative complication while in ward	Gastrointestinal complaints as nausea and vomiting, need to use antiemetic drug	up to 72 hours after surgery
urinary trak post-operative complication while in ward	Incidence of urinary retention and need for catheterization	up to 72 hours after surgery
post-operative pruritus while in ward	Pruritus	up to 72 hours after surgery
post-operative hospitalization	length of hospital stay by number of days	up to one week after surgery
Respiratory post-operative complication while recovering in post anesthesia care unit	Respiratory complication need of respiratory support, need of intensive care unit hospitalization)	up to 5 hours after surgery
septic post-operative complication while recovering in post anesthesia care unit	Development of fever above 38° C	up to 5 hours after surgery
Cardiovascular post-operative complication while recovering in post anesthesia care unit	Cardiovascular complication (hemodynamic instability, inotropic support )	up to 5 hours after surgery
Gastrointestinal post-operative complication while recovering in post anesthesia care unit	Gastrointestinal complication as nausea and vomiting, need to use antiemetic drugs	up to 5 hours after surgery
urinary retention post-operative complication while recovering in post anesthesia care unit	incience of urinary retention and need for catheterization	up to 5 hours after surgery
post-operative pruritus while recovering in post anesthesia care unit	Pruritus	up to 5 hours after surgery
post-operative stay in post anesthesia care unit	length of post anesthesia care unit stay by number of hours	up to 5 hours after surgery

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Investigators: 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 and helpful links

General Publications

• Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran 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.
• 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, Schalte G. [EzPAP(R) 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. doi: 10.1007/s12630-012-9760-2. Epub 2012 Jul 26.
• Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458.
• Macintyre PE, Loadsman JA, Scott DA. Opioids, ventilation and acute pain management. Anaesth Intensive Care. 2011 Jul;39(4):545-58. doi: 10.1177/0310057X1103900405.
• Schug SA, Raymann A. Postoperative pain management of the obese patient. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):73-81. doi: 10.1016/j.bpa.2010.12.001.
• Daszkiewicz A, Wylezol 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. doi: 10.1016/j.bpa.2010.02.001.
• 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.
• 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. doi: 10.1097/00000542-200112000-00013.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2017
• Primary Completion (ANTICIPATED): March 1, 2019
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (ACTUAL): July 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 23, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: gastrectomy; paracetamol; morbidly obese; ,elective sleeve; IV Perfelgan
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pain, Postoperative; Obesity, Morbid; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: sor17ybyrctil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No