Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy

Postoperative Pain Management Clinical Trial

— ibupro-hyst  

Official title:

Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy: Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691856
• Other study ID #: sedatakbas7
• Status: Completed
• Phase: N/A
• Start date: December 24, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2022
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists scores 1-3

• 18-65 years

Exclusion Criteria:

• American Society of Anesthesiologists scores IV,

• Under the age of 18,

• Over the age of 65,

• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Management

Intervention

Drug:
• Morphine Sulfate
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.
• 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 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.
• 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 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.
• Morphine
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.

Locations

Country	Name	City	State
Turkey	Sedat Akbas	Malatya	Türkiye-Türkçe

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Tunali Y, Akçil EF, Dilmen OK, Tutuncu AC, Koksal GM, Akbas S, Vehid H, Yentur E. Efficacy of intravenous paracetamol and dexketoprofen on postoperative pain and morphine consumption after a lumbar disk surgery. J Neurosurg Anesthesiol. 2013 Apr;25(2):143 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain scores	Visual Analog Scale (VAS, 0-10)	From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period
Secondary	Sedation score	Ramsey sedation score (1-6)	From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period
Secondary	Cumulative morphine consumption (mg)	All 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/h, lockout period: 7 min. Then cumulative morphine consumption will be recorded as milligram (mg).	From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period