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

Soroka University Medical Center

Status and phase: Unknown; Early Phase 1

Conditions: Obesity, Morbid

Treatments: Drug: IV paracetamol; Drug: IV saline (NaCl 0.9 %)

Study type: Interventional

Funder types: Other

Identifiers

NCT03221998

sor17ybyrctil

Details and patient eligibility

About

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 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

126 participants in 2 patient groups, including a placebo group

IV paracetamol

Experimental group

Description:

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

Treatment:

Drug: IV paracetamol

IV saline (NaCl 0.9 %)

Placebo Comparator group

Description:

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

Treatment:

Drug: IV saline (NaCl 0.9 %)