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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03221998
• Other study ID #: sor17ybyrctil
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: June 30, 2017
• Last updated: July 23, 2017
• Start date: July 2017
• Est. completion date: March 2020

Study information

• Verified date: July 2017
• Source: Soroka University Medical Center
• Contact: Yair Binyamin, MD
• Phone: +972586963871
• Email: Yairben1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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 — View Citation

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

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

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: 1 — View Citation

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. — View Citation

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/ — View Citation

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

* Note: There are 13 references in all — Click here to view all references

Outcome

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