- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03437707
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery (ibuprofen)
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery: Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All surgical procedures are associated with acute pain and inflammation, with varying degrees of severity for patients, causing significant stress and discomfort. Effective postoperative pain management in lumbar disc surgery may reduce complications and improve postoperative care. For postoperative pain, multimodal analgesic techniques are used to provide synergistic effects through different nociceptive mechanisms.
Various analgesics are used for pain. Opioids, commonly used for postoperative pain, are the most popular drug group. Side effects such as sedation, respiratory depression, nausea-vomiting, pruritus and urinary retention that develop secondary to opioids may also be reduced by the combination of supplemental analgesics.
Adjuvant agents, including nonsteroidal anti-inflammatory drugs (NSAID), may be used in combination with opioids. These drugs not only reduce pain but also control the underlying inflammatory process. In addition, combining NSAIDs and opioids can help to reduce the side effects by minimizing administration of total opioid consumption.
Intravenous (IV) ibuprofen is the first and only IV NSAID approved in the United States for both pain and fever control in adults. It has been reported in multicenter studies that IV ibuprofen is safe and effective in postoperative pain management for abdominal hysterectomy and orthopedic surgeries.
IV paracetamol is an analgesic and antipyretic agent used as a first step drug for pain and fever control in adults and children. It has been clearly shown that IV paracetamol, with analgesic efficacy and good safety profile, reduces analgesic requirements for pain management. It provides better analgesic efficacy and reduces opioid consumption when used in combination with opioids.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Türkiye-Türkçe
-
Malatya, Türkiye-Türkçe, Turkey, 44090
- Sedat Akbas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologists scores 1-3
- 18-85 years
Exclusion Criteria:
- American Society of Anesthesiologists scores IV,
- Under the age of 18,
- Over the age of 85,
- Peptic ulcer disease,
- Hepatic and renal dysfunction,
- Severe cardiovascular and pulmonary disease,
- Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and morphine,
- Emergency surgery,
- Refused informed consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: placebo
250 ml saline will be administered 30 minutes before the end of surgery.
All administrations will be applied through IV infusion over 30 minutes.
Patients will be received Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours.
The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml).
The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
|
Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours.
The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml).
The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Other Names:
|
ACTIVE_COMPARATOR: Intravenous paracetamol
1 g paracetamol will be administered 30 minutes before the end of surgery.
All administrations will be applied through IV infusion over 30 minutes.
Patients will be received Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours.
The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml).
The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
|
Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours.
The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml).
The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Other Names:
1 g paracetamol will be administered 30 minutes before the end of surgery.
All administrations will be applied through IV infusion over 30 minutes.
Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours.
The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml).
The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Other Names:
|
ACTIVE_COMPARATOR: Intravenous ibuprofen
800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery.
All administrations will be applied through IV infusion over 30 minutes.
Patients will be received Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours.
The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml).
The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
|
Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours.
The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml).
The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Other Names:
800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery.
All administrations will be applied through IV infusion over 30 minutes.
Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours.
The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml).
The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain scores
Time Frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
|
Visual Analog Scale (VAS, 0-10)
|
From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sedation score
Time Frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
|
Ramsey sedation score (1-6)
|
From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
|
Morphine consumption
Time Frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
|
Morphine
|
From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Acetaminophen
- Morphine
- Ibuprofen
Other Study ID Numbers
- sedatakbas2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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