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

Summary: 
      To compare the effects of intravenous paracetamol and ibuprofen on postoperative pain and
      morphine consumption in patients undergoing hysterectomy surgery and the side effects
      associated with opioids.
    

Detailed description: 
      All surgical procedures are associated with acute pain and inflammation, varying degrees of
      severity for the patients, causing significant stres and discomfort. Effective postoperative
      pain management in hysterectomy can reduce complications and improve postoperative care. In
      postoperative pain, multimodal analgesic techniques are used to provide synergistic effects
      through different nociceptive mechanisms.

      Hysterectomy is the second most common gynecological surgery performed after cesarean
      section. It is known that effective postoperative analgesia management decreases
      complications and increases patients' comfort.

      Various analgesics are used for pain. Opioids, frequently used for postoperative pain, are
      the most frequently used drug group. The combination of opioids with adjuvant agents may
      reduce the opioid consumption used systemically. Side effects such as sedation, respiratory
      depression, nausea, vomiting, rash and urinary retention that develop secondary to opioids
      may also be reduced by the combination of supplemental analgesics.

      Adjuvant agents, including nonsteroidal antiinflammatory drugs (NSAID), may be used in
      combination with opioids. NSAIDs do not only reduce pain, but also control the underlying
      inflammatory process. In addition, combining NSAIDs and opioids can help reduce the side
      effects by reducing administration of total opioid consumption.

      Intravenous ibuprofen is the first and only intravenous NSAID approved in the United States
      for both pain and fever control in adults. It has been reported in multicenter, randomized,
      double-blind, placebo-controlled studies that IV ibuprofen is safe and effective in
      postoperative pain management for abdominal hysterectomy and orthopedic surgeries.

      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 IV paracetamol,
      with analgesic efficacy and safety profile, reduces analgesic requirements for pain
      management. It has also been shown that it provides better analgesic efficacy and reduces the
      opioid consumption when used in combination with opioids.

      The investigators aimed to compare the effects of intravenous paracetamol and ibuprofen on
      postoperative pain and morphine consumption in patients undergoing hysterectomy surgery and
      the side effects associated with opioids.
    

Intervention name(s): Morphine Sulfate; Intravenous paracetamol; Intravenous ibuprofen; Morphine
Intervention type(s): Drug; 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.; All patients were instructed to use intravenous patient-controlled analgesia (IV PCA). 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: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postoperative pain; Intravenous paracetamol; Intravenous ibuprofen; Hysterectomy