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

Primary Purpose

Postoperative Pain Management

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tramadol
Paracetamol
Ibuprofen
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain Management focused on measuring Postoperative pain, Intravenous ibuprofen, Intravenous paracetamol, Shoulder surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muhittin Calim

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intravenous paracetamol

Intravenous ibuprofen

Arm Description

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 Tramadol with intravenous patient controlled analgesia (IV PCA) pump 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.

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) pump 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.

Outcomes

Primary Outcome Measures

Postoperative pain scores
Visual Analog Scale (VAS, 0-10)

Secondary Outcome Measures

Sedation score
Ramsey sedation score (1-6)
Tramadol consumption
Tramadol

Full Information

First Posted
May 30, 2022
Last Updated
August 16, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05401916
Brief Title
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery
Acronym
Ibuprofen
Official Title
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery: Prospective, Randomized, Double-Blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
April 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Management
Keywords
Postoperative pain, Intravenous ibuprofen, Intravenous paracetamol, Shoulder surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Randomized Double Blind Clinical Trial
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous paracetamol
Arm Type
Active Comparator
Arm Description
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 Tramadol with intravenous patient controlled analgesia (IV PCA) pump 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.
Arm Title
Intravenous ibuprofen
Arm Type
Active Comparator
Arm Description
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) pump 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.
Intervention Type
Drug
Intervention Name(s)
Tramadol
Other Intervention Name(s)
Intravenous patient-controlled analgesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Intravenous paracetamol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Intravenous ibuprofen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain scores
Description
Visual Analog Scale (VAS, 0-10)
Time Frame
From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Secondary Outcome Measure Information:
Title
Sedation score
Description
Ramsey sedation score (1-6)
Time Frame
From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Title
Tramadol consumption
Description
Tramadol
Time Frame
From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhittin MD Calim
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Director
Facility Information:
Facility Name
Muhittin Calim
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23360885
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.
Results Reference
result

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

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