Postoperative Pain Managementibupro-hystNCT04691856
Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy
A study testing Morphine Sulfate, Intravenous paracetamol and Intravenous ibuprofen in people with Postoperative Pain Management, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- Morphine Sulfate, Intravenous paracetamol and Intravenous ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2020to 28 Feb 2021
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists scores 1-3
- 18-65 years
Who cannot join
- 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,
Show all 9Show fewer
- Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and morphine,
- Emergency surgery,
- Refused informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy: Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Postoperative Pain Management
- Being tested
- Morphine Sulfate, Intravenous paracetamol, Intravenous ibuprofen, Morphine
- Keywords
- Postoperative pain, Intravenous paracetamol, Intravenous ibuprofen, Hysterectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
Also called Intravenous patient-controlled analgesia
Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Intravenous paracetamolDrug
Also called 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 morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Intravenous ibuprofenDrug
Also called 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 morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
MorphineDrug
All patients were instructed to use intravenous patient-controlled analgesia (IV PCA). All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 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 Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml/h, lockout period: 7 min. Receives: Drug: Morphine Sulfate; Drug: Morphine |
| Intravenous paracetamol | Active comparator | 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 Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml/h, lockout period: 7 min. Receives: Drug: Morphine Sulfate; Drug: Intravenous paracetamol; Drug: Morphine |
| 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 Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml/h, lockout period: 7 min. Receives: Drug: Morphine Sulfate; Drug: Intravenous ibuprofen; Drug: Morphine |
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 awakening of anesthesia) to postoperative 24-hour period
Secondary outcomes (2)
Sedation score
Ramsey sedation score (1-6)
Measured: From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period
Cumulative morphine consumption (mg)
All patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml/h, lockout period: 7 min. Then cumulative morphine consumption will be recorded as milligram (mg).
Measured: From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start24 Dec 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
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 Inonu 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, Placebo-Controlled Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sedat Akbas, Inonu University
- Investigators
- Sedat MD AKBAS, Study director, Inonu University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691856
- Sponsor's protocol ID
- sedatakbas7
- Acronym
- ibupro-hyst
- Status last verified
- Mar 2022
- First submitted
- 24 Dec 2020
- Last updated
- 11 Mar 2022
- 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 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy: Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04691856
- Acronym / sponsor ID
- ibupro-hyst / sedatakbas7
- Conditions
- Postoperative Pain Management
- Keywords
- Postoperative pain, Intravenous paracetamol, Intravenous ibuprofen, Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 31 Dec 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Prospective, Randomized, Placebo-Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Morphine Sulfate, Drug: Morphine250 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 Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml/h, lockout period: 7 min. |
| Intravenous paracetamol | Active comparator | Drug: Morphine Sulfate, Drug: Intravenous paracetamol, Drug: Morphine1 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 Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml/h, lockout period: 7 min. |
| Intravenous ibuprofen | Active comparator | Drug: Morphine Sulfate, Drug: Intravenous ibuprofen, Drug: Morphine800 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 Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml/h, lockout period: 7 min. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists scores 1-3
- 18-65 years
Key exclusion criteria (9 listed)
- American Society of Anesthesiologists scores IV,
- Under the age of 18,
- Over the age of 65,
- 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 |
|---|---|---|
| Morphine SulfateAlso: Intravenous patient-controlled analgesiaPatients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min. | Drug | Intravenous ibuprofen, Intravenous paracetamol, placebo |
| Intravenous paracetamolAlso: 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 morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min. | Drug | Intravenous paracetamol |
| Intravenous ibuprofenAlso: 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 morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min. | Drug | Intravenous ibuprofen |
| MorphineAll patients were instructed to use intravenous patient-controlled analgesia (IV PCA). All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min. | Drug | Intravenous ibuprofen, Intravenous paracetamol, placebo |
Primary outcome
Postoperative pain scores
Time frame: From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period
Visual Analog Scale (VAS, 0-10)
2 secondary outcomes
Sedation score
Time frame: From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period
Cumulative morphine consumption (mg)
Time frame: From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period
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 11 Mar 2022.
- 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.
Sedat MD AKBAS study director
Inonu University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine Sulfate, Intravenous paracetamol and Intravenous ibuprofen in people with Postoperative Pain Management, run by Inonu 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 9 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 11 Mar 2022. 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. Some participants in this study may receive a placebo. 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 awakening of anesthesia) to postoperative 24-hour period). 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 NCT04691856, 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 11 Mar 2022.