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Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03063658
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Menekse Ozcelik, Ankara University

Brief Summary:
This study will evaluate two different analgesic regimen used for acute postoperative pain.

Condition or disease Intervention/treatment Phase
Acute Pain Postoperative Pain Drug: Paracetamol Drug: Ibuprofen 800 mg Phase 4

Detailed Description:

Laparoscopic cholecystectomy is a type of surgery that causes moderate postoperative pain. Paracetamol and non-steroid anti-inflammatory analgesics plus opioids are the mainstay treatment options of the moderate postoperative pain. These drugs are the most common used analgesics to ameliorate this type of pain and to reduce the consumption of opioids and their side effects.

Ibuprofen is a well-known anti-inflammatory drug and has been used as an oral formula for a long time. Few studies using its new intravenous formula had been conducted to evaluate its effectiveness for mixed type of surgeries . However, its intravenous formula has not been studied for laparoscopic cholecystectomy. Therefore, this study will compare the effects of postoperative analgesic potencies of preemptive intravenous paracetamol and ibuprofen in patients undergoing laparoscopic cholecystectomy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of the Postoperative Analgesia Effectiveness of Preemptive Intravenous Ibuprofen and Paracetamol in Patients Undergoing Laparoscopic Cholecystectomy
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Paracetamol
Paracetamol (Paracerol) 1 gram will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.
Drug: Paracetamol
The first dose of 1 gr intravenous paracetamol will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.

Active Comparator: Ibuprofen
Ibuprofen (Intrafen) 800 mg will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.
Drug: Ibuprofen 800 mg
The first dose of 800 mg intravenous ibuprofen will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.




Primary Outcome Measures :
  1. Morphine consumption [ Time Frame: The first 24 hours after the completion of the surgery ]
    Total morphine consumption during the 24 hours of early postoperative period


Secondary Outcome Measures :
  1. VAS scores [ Time Frame: The first 24 hours after the completion of the surgery ]
    VAS scores at rest, at movement, at cough will be evaluated during the first 24 hours of early postoperative period

  2. Morphine side effects [ Time Frame: The first 24 hours after the completion of the surgery ]
    Morphine side effects such as nausea, vomiting, pruritus, constipation, urinary retention will be evaluated during the first 24 hours of early postoperative period



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. American Society of Anesthesiologist Functional Status 1-2
  2. Body mass index smaller than 30
  3. Undergoing laparoscopic cholecystectomy
  4. Age between 18-60 years

Exclusion Criteria:

  1. Age under 18, above 60
  2. Weight under 40 kg
  3. Body mass index above 30
  4. Contraindication for opioid and non-steroid anti-inflammatory drug usage
  5. Allergy against paracetamol, opioids and anti-inflammatory drugs
  6. Peptic ulcer
  7. Tendency to bleeding
  8. Pregnancy or breast feeding
  9. Moderate or severe renal, hepatic or cardiac insufficiency
  10. Coronary artery disease
  11. Asthma

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): NCT03063658


Contacts
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Contact: Menekse Ozcelik, M.D +905333521400 ozcelikmenekse@yahoo.com

Locations
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Turkey
Ankara University Faculty of Medicine Active, not recruiting
Ankara, Turkey, 06100
Ankara University School of Medicine Recruiting
Ankara, Turkey, 06660
Contact: Neslihan Alkis, Prof    +905323435055    alkisneslihan@gmail.com   
Sponsors and Collaborators
Ankara University
Investigators
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Principal Investigator: Zekeriyya Alanoglu, Professor Ankara University Department of Anesthesiology and Intensive Care Medicine

Publications:
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Responsible Party: Menekse Ozcelik, M.D, Ankara University
ClinicalTrials.gov Identifier: NCT03063658    
Other Study ID Numbers: 16-827-16
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Menekse Ozcelik, Ankara University:
Ibuprofen
Paracetamol
Laparoscopic cholecystectomy
Morphine
Visual analog scale
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics