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

Summary: 
      Primary aim of this prospective, randomized, double-blind clinical trial is to compare the
      analgesic effects of intravenous paracetamol and ibuprofen on postoperative pain, and
      secondary aim is the effects on tramadol consumption and side effects of tramadol in patients
      who underwent unilateral shoulder surgery.
    

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 shoulder 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, may be used in combination
      with opioids. These drugs not only reduce pain but also control the underlying inflammatory
      process. In addition, combining nonsteroidal anti-inflammatory drugs and opioids can help to
      reduce the side effects by minimizing administration of total opioid consumption.

      Intravenous 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 intravenous
      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.

      Intravenous ibuprofen is the first and only intravenous nonsteroidal anti-inflammatory drugs
      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 orthopedic surgeries.
    

Intervention name(s): Tramadol; Paracetamol; Ibuprofen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will be received tramadol with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 500 mg tramadol in 100 mL of saline (5 mg/ml). The PCA device was adjusted as infusion: 2 ml/h, bolus: 2 ml, lockout period: 15 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 tramadol with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 500 mg tramadol in 100 mL of saline (5 mg/ml). The PCA device was adjusted as infusion: 2 ml/h, bolus: 2 ml, lockout period: 15 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 tramadol with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 500 mg tramadol in 100 mL of saline (5 mg/ml). The PCA device was adjusted as infusion: 2 ml/h, bolus: 2 ml, lockout period: 15 min.
Other intervention name(s): Intravenous patient-controlled analgesia; Intravenous paracetamol; Intravenous ibuprofen
Intervention MeSH terms: Acetaminophen; Ibuprofen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized Double Blind Clinical Trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Postoperative pain; Intravenous ibuprofen; Intravenous paracetamol; Shoulder surgery