Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04691856
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2020-12-24
Brief Title:
Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy
Sponsor:
Inonu University
Organization:
Inonu University
Study Overview
Official Title:
Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy Prospective Randomized Double-Blind Placebo-Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ibupro-hyst
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None