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Morphine-sparing Effect of Intravenous Paracetamol for Post-operative Pain Management Following Laparoscopic Gastric Banding in Morbidly Obese Patients

S

Soroka University Medical Center

Status

Unknown

Conditions

Obesity

Treatments

Drug: Placebo
Drug: Paracetamol

Study type

Interventional

Funder types

Other

Identifiers

NCT02154464
SOR 0024-14 CTIL

Details and patient eligibility

About

The investigators predict that giving patients paracetamol in the operative period will reduce their need for opioid pain reducers in the post operative setting.

Full description

This study is designed as a population-based prospective, double blind cohort study. A prospective cohort of patients admitted to laparoscopic gastric banding due to morbid obesity

STUDY GOALS

  • To evaluate the morphine-sparing effect of paracetamol IV in obese patients undergoing bariatric surgery.
  • To identify potential ability of paracetamol IV to attenuate or relief postoperative pain in obesity patient undergoing bariatric surgery
  • To determine effectiveness of paracetamol IV to reduce postoperative complication rate.

Enrollment

220 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age ≥18 years
  • Patients admitted for laparoscopic gastric banding
  • Elective surgery
  • BMI > 40
  • ASA (American Society Anesthesiologists perioperative risk stratification) class 1-2

Exclusion criteria

  • Patients' refusal to participate in the study
  • Patients unable to give an informed consent
  • Pregnancy
  • Emergent surgery
  • Patient with known allergy to morphine or paracetamol
  • Patient with hepatic failure (based on history or elevated liver enzymes).
  • ASA class >2.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

220 participants in 2 patient groups, including a placebo group

Paracetamol
Active Comparator group
Treatment:
Drug: Paracetamol
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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