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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracetamol<br> | Drug: Paracetamol<br> <br> * Other names: Perfalgan;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of morphine | The primary outcome will be the comparison amount of morphine injected in each group until discharge | Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication during treatment of patient in PACU: | 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 | Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours) | 
| 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. | Complications during hospitalization, including : Septic complications Respiratory, cardiac or other complications | Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morphine-sparing, Paracetamol, Obesity, Gastric banding