The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- measuring of Visual Analogue pain Scale, [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 [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
- Total consumption of opiates after surgery [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 [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 [up to 72 hours after surgery]
development of fever above 38° C
- Cardiovascular post-operative complication while in ward [up to 72 hours after surgery]
Cardiovascular complication (hemodynamic instability, inotropic support )
- Gastrointestinal post-operative complication while in ward [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 [up to 72 hours after surgery]
Incidence of urinary retention and need for catheterization
- post-operative pruritus while in ward [up to 72 hours after surgery]
Pruritus
- post-operative hospitalization [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 [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 [up to 5 hours after surgery]
Development of fever above 38° C
- Cardiovascular post-operative complication while recovering in post anesthesia care unit [up to 5 hours after surgery]
Cardiovascular complication (hemodynamic instability, inotropic support )
- Gastrointestinal post-operative complication while recovering in post anesthesia care unit [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 [up to 5 hours after surgery]
incience of urinary retention and need for catheterization
- post-operative pruritus while recovering in post anesthesia care unit [up to 5 hours after surgery]
Pruritus
- post-operative stay in post anesthesia care unit [up to 5 hours after surgery]
length of post anesthesia care unit stay by number of hours
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- sor17ybyrctil