Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery

Postoperative Pain Management Clinical Trial

— Ibuprofen  

Official title:

Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery: Prospective, Randomized, Double-Blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05401916
• Other study ID #: muhittincalim2
• Status: Completed
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: April 9, 2023

Study information

• Verified date: August 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists scores 1-3

• 18-85 years

Exclusion Criteria:

• American Society of Anesthesiologists scores IV,

• Under the age of 18,

• Over the age of 85,

• Peptic ulcer disease,

• Hepatic and renal dysfunction,

• Severe cardiovascular and pulmonary disease,

• Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and tramadol,

• Emergency surgery

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Management

Intervention

Drug:
• Tramadol
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.
• 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 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.
• 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 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.

Locations

Country	Name	City	State
Turkey	Muhittin Calim	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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 — 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 anesthesia) to after 24 hours, up to 24 hours
Secondary	Sedation score	Ramsey sedation score (1-6)	From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Secondary	Tramadol consumption	Tramadol	From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours