Clinical trial NCT04691856: Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy
Official title: Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy: Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain Management
Keywords: Postoperative pain
Intravenous paracetamol
Intravenous ibuprofen
Hysterectomy
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Placebo-Controlled Clinical Trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain scores
timeFrame: From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period
Secondary outcomes:
measure: Sedation score
timeFrame: From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period
measure: Cumulative morphine consumption (mg)
timeFrame: From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Sedat Akbas
state: Türkiye-Türkçe
Study officials:
affiliation: Inonu University Medical Faculty
name: Sedat MD AKBAS
role: STUDY_DIRECTOR
References:
citation: Tunali Y, Akcil 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):143-7. doi: 10.1097/ANA.0b013e31827464af.