Postoperative Pain ManagementIbuprofenNCT05401916
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery
A study testing Tramadol, Paracetamol and Ibuprofen in people with Postoperative Pain Management, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- Tramadol, Paracetamol and Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2022to 9 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists scores 1-3
- 18-85 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery: Prospective, Randomized, Double-Blind Clinical Trial
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.
Read the 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.
- Conditions
- Postoperative Pain Management
- Being tested
- Tramadol, Paracetamol, Ibuprofen
- Keywords
- Postoperative pain, Intravenous ibuprofen, Intravenous paracetamol, Shoulder surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Also called Intravenous patient-controlled analgesia
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.
ParacetamolDrug
Also called 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) 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.
IbuprofenDrug
Also called 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous paracetamol | Active comparator | 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. Receives: Drug: Tramadol; Drug: Paracetamol |
| Intravenous ibuprofen | Active comparator | 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. Receives: Drug: Tramadol; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores
Visual Analog Scale (VAS, 0-10)
Measured: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Secondary outcomes (2)
Sedation score
Ramsey sedation score (1-6)
Measured: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Tramadol consumption
Tramadol
Measured: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start10 Jun 2022
- Primary completion9 Mar 2023
- Study completion9 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized Double Blind Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhittin Calim, Bezmialem Vakif University
- Investigators
- Muhittin MD Calim, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401916
- Sponsor's protocol ID
- muhittincalim2
- Acronym
- Ibuprofen
- Status last verified
- Aug 2023
- First submitted
- 30 May 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23360885
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery: Prospective, Randomized, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05401916
- Acronym / sponsor ID
- Ibuprofen / muhittincalim2
- Conditions
- Postoperative Pain Management
- Keywords
- Postoperative pain, Intravenous ibuprofen, Intravenous paracetamol, Shoulder surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Apr 2023 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, Randomized Double Blind Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Intravenous paracetamol | Active comparator | Drug: Tramadol, Drug: ParacetamolIntravenous 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. |
| Intravenous ibuprofen | Active comparator | Drug: Tramadol, Drug: Ibuprofen800 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists scores 1-3
- 18-85 years
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists scores IV,
- Under the age of 18,
- Over the age of 85,
- Peptic ulcer disease,
- Hepatic and renal dysfunction,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TramadolAlso: Intravenous patient-controlled analgesiaPatients 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. | Drug | Intravenous ibuprofen, Intravenous paracetamol |
| ParacetamolAlso: Intravenous paracetamol1 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. | Drug | Intravenous paracetamol |
| IbuprofenAlso: Intravenous ibuprofen800 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. | Drug | Intravenous ibuprofen |
Primary outcome
Postoperative pain scores
Time frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Visual Analog Scale (VAS, 0-10)
2 secondary outcomes
Sedation score
Time frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Tramadol consumption
Time frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Results publication: PubMed 23360885Tunali 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhittin MD Calim study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tramadol, Paracetamol and Ibuprofen in people with Postoperative Pain Management, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain scores (time frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05401916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.