Obesity
Conditions
Keywords
Morphine-sparing, Paracetamol, Obesity, Gastric banding
Brief summary
The investigators predict that giving patients paracetamol in the operative period will reduce their need for opioid pain reducers in the post operative setting.
Detailed 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.
Interventions
DRUGParacetamol
DRUGPlacebo
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| amount of morphine | Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days) | The primary outcome will be the comparison amount of morphine injected in each group until discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication during treatment of patient in PACU: | Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours) | Complication during treatment of patient in PACU, including: * Respiratory complications (respiratory support, need for ICU, etc) * Cardiovascular complications (hemodynamic instability, inotropic support ) * Gastrointestinal complications (nausea and vomiting tested by PONV scale, need to use antiemetic drugs) * Incidence of urinary retention and need for catheterization * Pruritus |
| Time discharging from PACU | Until discharge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours) | — |
| Length of hospitalization | Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days) | — |
| Complications during hospitalization. | Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days) | Complications during hospitalization, including : * Septic complications * Respiratory, cardiac or other complications |
Countries
Israel
Outcome results
None listed