Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery
Condition: Postoperative Pain Management
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Primary aim of this prospective, randomized, double-blind, placebo-controlled clinical trial
      is to compare the analgesic effects of IV ibuprofen and paracetamol on postoperative pain,
      and secondary aim is the effects on morphine consumption and side effects of morphine in
      patients who underwent lumbar disc surgery with a single level laminectomy or discectomy.
    

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.
    

Intervention name(s): Morphine Sulfate; Intravenous paracetamol; Intravenous ibuprofen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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 intervention name(s): Intravenous patient-controlled analgesia; paracetamol; ibuprofen
Intervention MeSH terms: Acetaminophen; Ibuprofen; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, Placebo-Controlled Clinical Trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Postoperative pain; Intravenous ibuprofen; Intravenous paracetamol; Lumbar disc surgery