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

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ClinicalTrials.gov Identifier: NCT02154464
Recruitment Status : Unknown
Verified May 2014 by Alexander Zlotnik, Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Alexander Zlotnik, Soroka University Medical Center

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Paracetamol Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Morphine-sparing Effect of Intravenous Paracetamol for Post-operative Pain Management Following Laparoscopic Gastric Banding in Morbidly Obese Patients
Study Start Date : June 2014
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Paracetamol Drug: Paracetamol
Other Name: Perfalgan

Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. amount of morphine [ Time Frame: 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 Outcome Measures :
  1. Complication during treatment of patient in PACU: [ Time Frame: 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

  2. Time discharging from PACU [ Time Frame: Until discharge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours) ]
  3. Length of hospitalization [ Time Frame: Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days) ]
  4. Complications during hospitalization. [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154464


Locations
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Israel
Soroka Medical Center, Ben Gurion University of the Negev
Beer Sheva, Israel
Contact: Alexander Zlotnik, M.D. Ph.D.         
Sponsors and Collaborators
Soroka University Medical Center

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Responsible Party: Alexander Zlotnik, Professor, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT02154464    
Other Study ID Numbers: SOR 0024-14 CTIL
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014
Keywords provided by Alexander Zlotnik, Soroka University Medical Center:
Morphine-sparing
Paracetamol
Obesity
Gastric banding
Additional relevant MeSH terms:
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Pain, Postoperative
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics