Compare Unimodal and Multimodal AnalgesicsPhase 1/2NCT05547659
Multimodal and Unimodal Analgesia in Cholecystectomy
A Phase 1/2 study testing Pregabalin 150mg, Acetaminophen 1 G Oral Tablet and Celecoxib 400Mg Oral Capsule in people with Compare Unimodal and Multimodal Analgesics, run by October 6 University at 2 sites in Egypt.
Trial summary
Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Compare Unimodal and Multimodal Analgesics
- What is being tested?
- Pregabalin 150mg, Acetaminophen 1 G Oral Tablet and Celecoxib 400Mg Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2019to 1 Dec 2020
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing laparoscopic cholecystectomy
- Patients older than 18 years old
Who cannot join
- Renal or hepatic or cardiac impairment patients
- Patients with chronic pain history
- Allergic patients after taking aspirin or other NSAIDs
- patients with active gastrointestinal bleeding, ulcer and inflammatory bowel diseases or cerebrovascular bleeding
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Beni suef University hospital
Banī Suwayf
Beni-Suef Hospital
Banī Suwayf
About this study
Official title: Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy
Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce length of hospital stay and achieve early mobilization after surgery, decreasing opioid consumption and its side effects that are constipation, nausea, vomiting, dizziness, respiratory depression which is the most feared complication being life-threatening and some less common side effects as sedation
- Being tested
- Pregabalin 150mg, Acetaminophen 1 G Oral Tablet, Celecoxib 400Mg Oral Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group
Acetaminophen 1 G Oral TabletDrug
Acetaminophen 1 G Oral Tablet preoperative in multi-modal group
Celecoxib 400Mg Oral CapsuleDrug
Celecoxib 400Mg Oral Capsule preoperative in multi-modal group
| Study group | Role | What they receive |
|---|---|---|
| multimodal | Active comparator | pregabalin/ acetaminophen/ celecoxib Receives: Drug: Pregabalin 150mg; Drug: Acetaminophen 1 G Oral Tablet; Drug: Celecoxib 400Mg Oral Capsule |
| unimodal | Active comparator | Pregabalin Receives: Drug: Pregabalin 150mg |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative visual analogue scale (VAS)
The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.
Measured: 24 hour postoperative
Amount of post operative Needed opioid analgesia
ampules of opioid analgesia needed after operation
Measured: 24 hour postoperative
Secondary outcomes (1)
Type and amount of prescribed post operative non opioid analgesia
Type and amount of prescribed post operative non opioid analgesia
Measured: 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Jan 2019
- Primary completion1 Apr 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare Unimodal and Multimodal AnalgesicsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Beni-Suef University
- Responsible party
- Principal investigator, engy wahsh, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547659
- Sponsor's protocol ID
- FWA00015574
- Status last verified
- Sep 2022
- First submitted
- 25 Aug 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy
- ClinicalTrials.gov ID
- NCT05547659
- Acronym / sponsor ID
- FWA00015574
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Beni-Suef University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 21 Sep 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.
Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce length of hospital stay and achieve early mobilization after surgery, decreasing opioid consumption and its side effects that are constipation, nausea, vomiting, dizziness, respiratory depression which is the most feared complication being life-threatening and some less common side effects as sedation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| multimodal | Active comparator | Drug: Pregabalin 150mg, Drug: Acetaminophen 1 G Oral Tablet, Drug: Celecoxib 400Mg Oral Capsulepregabalin/ acetaminophen/ celecoxib |
| unimodal | Active comparator | Drug: Pregabalin 150mgPregabalin |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients undergoing laparoscopic cholecystectomy
- Patients older than 18 years old
Key exclusion criteria (4 listed)
- Renal or hepatic or cardiac impairment patients
- Patients with chronic pain history
- Allergic patients after taking aspirin or other NSAIDs
- patients with active gastrointestinal bleeding, ulcer and inflammatory bowel diseases or cerebrovascular bleeding
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 |
|---|---|---|
| Pregabalin 150mgPregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group | Drug | multimodal, unimodal |
| Acetaminophen 1 G Oral TabletAcetaminophen 1 G Oral Tablet preoperative in multi-modal group | Drug | multimodal |
| Celecoxib 400Mg Oral CapsuleCelecoxib 400Mg Oral Capsule preoperative in multi-modal group | Drug | multimodal |
Primary outcome
Postoperative visual analogue scale (VAS)
Time frame: 24 hour postoperative
The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.
Amount of post operative Needed opioid analgesia
Time frame: 24 hour postoperative
ampules of opioid analgesia needed after operation
1 secondary outcome
Type and amount of prescribed post operative non opioid analgesia
Time frame: 24 hour postoperative
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 21 Sep 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pregabalin 150mg, Acetaminophen 1 G Oral Tablet and Celecoxib 400Mg Oral Capsule in people with Compare Unimodal and Multimodal Analgesics, run by October 6 University at 2 sites in Egypt.
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 4 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 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Postoperative visual analogue scale (VAS) (time frame: 24 hour postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2022.