Acute Post-operative PainPhase 4NCT06478758
Ibuprofen Use on Post-operative Pain Following Cholecystectomy
A Phase 4 study testing Ibuprofen 400 mg and Acetaminophen 100 MG/ML in people with Acute Post-operative Pain, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Post-operative Pain
- What is being tested?
- Ibuprofen 400 mg and Acetaminophen 100 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 30 Apr 2024
- Phase
- Phase 4
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA grade I-II patients
- Aged 18-65 years
Who cannot join
- History of allergies or hypersensitivity to the aforementioned agents
- Renal, hepatic or gastrointestinal disease
- Significant cognitive impairment
- Recent use of long-term nonsteroid anti-inflammatory and opioids
- Oral anticoagulant use or known bleeding disorders
- Diabetes or any other neuropathic diseases
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen.
Read the detailed description
Ibuprofen is a widely used NSAID that has antipyretic, analgesic, and anti-inflammatory effects. In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy.The participants in this study were randomized into two groups. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen. The investigators recorded demographic data including gender, age, ASA, BMI, duration of anesthesia and surgery, poNV, LOS, VAS scores and opioid consumption postoperatively.
- Conditions
- Acute Post-operative Pain
- Being tested
- Ibuprofen 400 mg, Acetaminophen 100 MG/ML
- Keywords
- intravenous ibuprofen, acetaminophen, laparoscopic cholecystectomy, postoperative pain control, analgesia, anti-inflammatory agents
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 400 mgDrug
The ibuprofen group (n=36) was administered 800 mg of ibuprofen . All procedures were performed with the same team. During surgery, a 20% increase in the participant's heart rate and mean arterial pressure remifentanil infusion was administered. During the postoperative period, all participants continued to receive acetaminophen at 8-hour intervals, and tramadol was given to those with a visual analog score above 4. In the recovery room, the participants with a visual analog score of > 4 were administered 100 mg of tramadol. All participants were prescribed acetaminophen every 8 hours postoperatively in whilst on the ward. Participants with a visual analog score of > 4 received rescue analgesia with 100 mg of tramadol. Visual analog score and vital parameters were recorded at 1, 2, 6, 12 and 24 h postoperatively. The incidence of nausea and vomiting during the 24 h postoperative period was also recorded.
Acetaminophen 100 MG/MLDrug
The investigators administered 1000 mg of acetaminophen to the participants in Group A. A 20% increase in the participant's heart rate and mean arterial pressure was evaluated as pain and remifentanil infusion was administered. All participants continued to receive the routine application of acetaminophen at 8-hour intervals, and tramadol was given to those with a visual analog score above 4, postoperatively.In the recovery room, participants with a visual analog score of > 4 were administered 100 mg of tramadol. All participants were prescribed acetaminophen every 8 hours postoperatively in whilst on the ward. Participants with a visual analog score of > 4 received rescue analgesia with 100 mg of tramadol. Visual analog score and vital parameters were recorded at 1, 2, 6, 12 and 24 h postoperatively. The incidence of nausea and vomiting during the 24 h postoperative period was also recorded.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen group | Active comparator | The acetaminophen group (n=35) received 1000 of mg acetaminophen intravenously in 100 mL saline at the end of the cholecystectomy. Receives: Drug: Acetaminophen 100 MG/ML |
| Ibuprofen group | Experimental | The ibuprofen group (n=36) was administered 800 mg of ibuprofen at the end of the cholecystectomy. Receives: Drug: Ibuprofen 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scores in the postoperative period
Primary outcome was to reduce the VAS scores in the postoperative period. For this purpose the investigators recorded VAS scores at the 1, 2, 6, 12 and 24 h postoperatively.
Measured: 24 hour
Secondary outcomes (1)
Opioid consumption and length of stay
Secondary outcome was any decrease in opioid consumption and hospitalization.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Feb 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Post-operative PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study included ASA grade I-II participants aged 18-65 years scheduled for laparoscopic cholecystectomy. Participants with a history of allergies or hypersensitivity to the aforementioned agents, renal, hepatic or gastrointestinal disease, significant cognitive impairment, recent use of long-term nonsteroid anti-inflammatory and opioids, oral anticoagulant use or known bleeding disorders, diabetes or any other neuropathic diseases and those who were pregnant or breastfeeding were excluded from the study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azime Bulut, MD, Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478758
- Sponsor's protocol ID
- KAEK-230
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahiskalioglu EO, Ahiskalioglu A, Aydin P, Yayik AM, Temiz A. Effects of single-dose preemptive intravenous ibuprofen on postoperative opioid consumption and acute pain after laparoscopic cholecystectomy. Medicine (Baltimore). 2017 Feb;96(8):e6200. doi: 10.1097/MD.0000000000006200.
PubMed 28225506Ciftci B, Ekinci M, Celik EC, Kaciroglu A, Karakaya MA, Demiraran Y, Ozdenkaya Y. Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study. Obes Surg. 2019 Mar;29(3):765-770. doi: 10.1007/s11695-018-3613-1.
PubMed 30474791Mohammadian Erdi A, Arabzadeh A, Isazadehfar K, Masoumzadeh M, Bahadoram M. Comparing the Efficacy and Side Effects of Intravenous Ibuprofen and Acetaminophen in Pain Control Following Laparoscopic Cholecystectomy. World J Plast Surg. 2022 Mar;11(1):117-124. doi: 10.52547/wjps.11.1.117.
PubMed 35592235Celik EC, Kara D, Koc E, Yayik AM. The comparison of single-dose preemptive intravenous ibuprofen and paracetamol on postoperative pain scores and opioid consumption after open septorhinoplasty: a randomized controlled study. Eur Arch Otorhinolaryngol. 2018 Sep;275(9):2259-2263. doi: 10.1007/s00405-018-5065-6. Epub 2018 Jul 18.
PubMed 30022362
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen Use on Post-operative Pain Following Cholecystectomy
- ClinicalTrials.gov ID
- NCT06478758
- Acronym / sponsor ID
- KAEK-230
- Conditions
- Acute Post-operative Pain
- Keywords
- intravenous ibuprofen, acetaminophen, laparoscopic cholecystectomy, postoperative pain control, analgesia, anti-inflammatory agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 27 Jun 2024 (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.
In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen.
Detailed description
Ibuprofen is a widely used NSAID that has antipyretic, analgesic, and anti-inflammatory effects. In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy.The participants in this study were randomized into two groups. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen. The investigators recorded demographic data including gender, age, ASA, BMI, duration of anesthesia and surgery, poNV, LOS, VAS scores and opioid consumption postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The present study included ASA grade I-II participants aged 18-65 years scheduled for laparoscopic cholecystectomy. Participants with a history of allergies or hypersensitivity to the aforementioned agents, renal, hepatic or gastrointestinal disease, significant cognitive impairment, recent use of long-term nonsteroid anti-inflammatory and opioids, oral anticoagulant use or known bleeding disorders, diabetes or any other neuropathic diseases and those who were pregnant or breastfeeding were excluded from the study.
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen group | Active comparator | Drug: Acetaminophen 100 MG/MLThe acetaminophen group (n=35) received 1000 of mg acetaminophen intravenously in 100 mL saline at the end of the cholecystectomy. |
| Ibuprofen group | Experimental | Drug: Ibuprofen 400 mgThe ibuprofen group (n=36) was administered 800 mg of ibuprofen at the end of the cholecystectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA grade I-II patients
- Aged 18-65 years
Key exclusion criteria (7 listed)
- History of allergies or hypersensitivity to the aforementioned agents
- Renal, hepatic or gastrointestinal disease
- Significant cognitive impairment
- Recent use of long-term nonsteroid anti-inflammatory and opioids
- Oral anticoagulant use or known bleeding disorders
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 |
|---|---|---|
| Ibuprofen 400 mgThe ibuprofen group (n=36) was administered 800 mg of ibuprofen . All procedures were performed with the same team. During surgery, a 20% increase in the participant's heart rate and mean arterial pressure remifentanil infusion was administered. During the postoperative period, all participants continued to receive acetaminophen at 8-hour intervals, and tramadol was given to those with a visual analog score above 4. In the recovery room, the participants with a visual analog score of > 4 were administered 100 mg of tramadol. All participants were prescribed acetaminophen every 8 hours postoperatively in whilst on the ward. Participants with a visual analog score of > 4 received rescue analgesia with 100 mg of tramadol. Visual analog score and vital parameters were recorded at 1, 2, 6, 12 and 24 h postoperatively. The incidence of nausea and vomiting during the 24 h postoperative period was also recorded. | Drug | Ibuprofen group |
| Acetaminophen 100 MG/MLThe investigators administered 1000 mg of acetaminophen to the participants in Group A. A 20% increase in the participant's heart rate and mean arterial pressure was evaluated as pain and remifentanil infusion was administered. All participants continued to receive the routine application of acetaminophen at 8-hour intervals, and tramadol was given to those with a visual analog score above 4, postoperatively.In the recovery room, participants with a visual analog score of > 4 were administered 100 mg of tramadol. All participants were prescribed acetaminophen every 8 hours postoperatively in whilst on the ward. Participants with a visual analog score of > 4 received rescue analgesia with 100 mg of tramadol. Visual analog score and vital parameters were recorded at 1, 2, 6, 12 and 24 h postoperatively. The incidence of nausea and vomiting during the 24 h postoperative period was also recorded. | Drug | Acetaminophen group |
Primary outcome
VAS scores in the postoperative period
Time frame: 24 hour
Primary outcome was to reduce the VAS scores in the postoperative period. For this purpose the investigators recorded VAS scores at the 1, 2, 6, 12 and 24 h postoperatively.
1 secondary outcome
Opioid consumption and length of stay
Time frame: 24 hour
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 27 Jun 2024.
- Results publication: PubMed 28225506Ahiskalioglu EO, Ahiskalioglu A, Aydin P, Yayik AM, Temiz A. Effects of single-dose preemptive intravenous ibuprofen on postoperative opioid consumption and acute pain after laparoscopic cholecystectomy. Medicine (Baltimore). 2017 Feb;96(8):e6200. doi: 10.1097/MD.0000000000006200.
- Results publication: PubMed 30474791Ciftci B, Ekinci M, Celik EC, Kaciroglu A, Karakaya MA, Demiraran Y, Ozdenkaya Y. Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study. Obes Surg. 2019 Mar;29(3):765-770. doi: 10.1007/s11695-018-3613-1.
- Results publication: PubMed 35592235Mohammadian Erdi A, Arabzadeh A, Isazadehfar K, Masoumzadeh M, Bahadoram M. Comparing the Efficacy and Side Effects of Intravenous Ibuprofen and Acetaminophen in Pain Control Following Laparoscopic Cholecystectomy. World J Plast Surg. 2022 Mar;11(1):117-124. doi: 10.52547/wjps.11.1.117.
- Results publication: PubMed 30022362Celik EC, Kara D, Koc E, Yayik AM. The comparison of single-dose preemptive intravenous ibuprofen and paracetamol on postoperative pain scores and opioid consumption after open septorhinoplasty: a randomized controlled study. Eur Arch Otorhinolaryngol. 2018 Sep;275(9):2259-2263. doi: 10.1007/s00405-018-5065-6. Epub 2018 Jul 18.
- Individual participant dataSharing planned: No
Related trials for Acute Post-operative Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Recruiting
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
Postoperative Pain, Acute, Shoulder Pain
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
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.
Azime Bulut, MD principal investigator
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen 400 mg and Acetaminophen 100 MG/ML in people with Acute Post-operative Pain, run by Giresun 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 7 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 27 Jun 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
VAS scores in the postoperative period (time frame: 24 hour). 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 NCT06478758, which also lists 4 linked publications.
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 27 Jun 2024.