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

NCT03221998 | Unknown Early Phase 1 DMC

• 1 other identifier: sor17ybyrctil
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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

Conditions

Obesity, Morbid

Keywords

morbidly obese; ,elective sleeve; gastrectomy; paracetamol; IV Perfelgan

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Total consumption of opiates after surgery

  up to 72 hours after surgery

• Respiratory post-operative complication while in ward

  up to 72 hours after surgery

• septic post-operative complication while in ward

  up to 72 hours after surgery

• Cardiovascular post-operative complication while in ward

  up to 72 hours after surgery

• Gastrointestinal post-operative complication while in ward

  up to 72 hours after surgery

Study Arms (2)

IV paracetamol

EXPERIMENTAL

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

IV saline (NaCl 0.9 %)

PLACEBO COMPARATOR

Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative

Drug: IV saline (NaCl 0.9 %)

Interventions

IV paracetamol DRUG

100 gram paracetamol infusion for moderate pain management

Also known as: Perfalgan infusion (paracetamol)

IV paracetamol

IV saline (NaCl 0.9 %) DRUG

100 ml of Normal Saline (IV NaCl 0.9 %) as placebo

Also known as: Normal Saline

IV saline (NaCl 0.9 %)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Patients admitted for laparoscopic sleeve gastrectomy
• Elective surgery
• BMI \> 40
• American Society of Anesthesiology Classification: 1-2

You may not qualify if:

• 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

Sponsors & Collaborators

• Soroka University Medical Center: lead

Related Publications (13)

• 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.

  PMID: 27177956 BACKGROUND

• 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.

  PMID: 23054575 RESULT

• 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.

  PMID: 23011043 RESULT

• 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.

  PMID: 22833138 RESULT

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

  PMID: 22250276 RESULT

• 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.

  PMID: 21823370 RESULT

• 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.

  PMID: 21516915 RESULT

• 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.

  PMID: 21252836 RESULT

• 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.

  PMID: 21224800 RESULT

• 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.

  PMID: 20608558 RESULT

• 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.

  PMID: 19961114 RESULT

• 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.

  PMID: 11748392 RESULT

• 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.

  PMID: 21495003 RESULT

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Acetaminophen; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Michael Semionov, MD

  Soroka University Medical Center-Department of Anesthesiology

  STUDY DIRECTOR

• Alexander Zlotnic, PhdMD

  Soroka University Medical Center-Department of Anesthesiology

  STUDY CHAIR

• Yair Binyamin, MD

  Soroka University Medical Center-Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

• Yair Yaish Reina, MD

  Soroka University Medical Center-Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yair Binyamin, MD

CONTACT

+972586963871; Yairben1@gmail.com

Yair Yaish Reina, MD

CONTACT

+972545442655; yair0026@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal lnvestigator

Model Details: 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 Record Dates

• First Submitted: June 30, 2017
• First Posted: July 19, 2017
• Study Start: July 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: July 25, 2017

Record last verified: 2017-07