AnesthesiaPhase 4NCT05050656
Oral Duloxetine as a Premedication for Postoperative Pain Control
A Phase 4 study testing Duloxetine 60mg in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of the study is to use duloxetine as premedication in Anterior cruciate ligament repair under spinal anesthesia and evaluate the effect on onset and duration of spinal anesthesia and postoperative pain control. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Duloxetine 60mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2021to 29 Jul 2021
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists I or II.
- Sex: Both sexes.
- Age between 18 and 50.
- Height 155-180 cm.
- Patients scheduled for arthroscopic anterior cruciate ligament (ACL) repair under spinal anesthesia.
Who cannot join
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- Had a history of drug or alcohol abuse.
- Taking opioids or sedative medications.
- Inability to communicate with patients to evaluate the postoperative pain.
- Need for postoperative ICU hospitalization.
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- Hepatic or renal failure.
- Patients with a history of taking duloxetine or any SSRIs.
- Contraindications to regional anesthesia (including coagulopathy and local infection).
- Psychiatric disorders with antipsycotics or antidepressants (tricylic or MAOIs).
- Antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).
- Quinolones (ciprofloxacin).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Preoperative Oral Duloxetine: Does it Affect Duration of Spinal Anesthesia and Early Postoperative Pain After Arthroscopic ACL Repair?" a Prospective, Randomized, Double-blind Controlled Trial
The purpose of the study is to use duloxetine as premedication in Anterior cruciate ligament repair under spinal anesthesia and evaluate the effect on onset and duration of spinal anesthesia and postoperative pain control.
Read the detailed description
We designed this randomized, double-blind study to evaluate the effectiveness of administration of oral duloxetine 2 hours preoperatively on the onset and the duration of the spinal anesthesia in arthroscopic anterior cruciate ligament (ACL) repair and the role of duloxetine on postoperative analgesia.
- Conditions
- Anesthesia
- Being tested
- Duloxetine 60mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine 60mgDrug
Duloxetine is a selective SNRI prescribed in depression, anxiety, and chronic pain like diabetic neuropathy and fibromyalgia, it acts through central and peripheral pain modulation
PlaceboDrug
placebo tablets identical to duloxetine tablets
| Study group | Role | What they receive |
|---|---|---|
| Group D (duloxetine group) | Active comparator | Two hours before surgery, participants received oral duloxetine 60 mg tablets in the ward then transferred to OR to receive spinal anesthesia before surgery. Receives: Drug: Duloxetine 60mg |
| Group C (control group) | Placebo comparator | Two hours before surgery, participants received oral placebo tablets in the ward then transferred to OR to receive spinal anesthesia before surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the onset of spinal anesthesia
Time to T10 sensory block and time to Bromage 1 motor block
Measured: 20 min
Secondary outcomes (3)
Duration of spinal anesthesia
Two-dermatomes regression for sensory recovery and return to Bromage 2 for motor recovery
Measured: 4 hours
Postoperative pain
Will be assessed by the patient using the visual analog scale (VAS, 0=no pain; 10=worst possible pain) every 4hrs up to 24hrs after the operation.
Measured: 24 hours
Time for first postoperative rescue analgesia request, frequency, and total morphine consumption
All participants will receive intravenous paracetamol, one gram every 8hrs, VAS score of 4 or more will receive 3 mg morphine intravenously and not be repeated more frequently than 4hrs limited to 12 mg morphine per 24hrs after operation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start15 Mar 2021
- Primary completion28 Jul 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Samir Abdelsalam, Ain Shams University
- Investigators
- tamer abdelaziz, MD, Principal investigator, Faculty of medicine, Ain Shams University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050656
- Sponsor's protocol ID
- FMASU R 63/ 2021
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Preoperative Oral Duloxetine: Does it Affect Duration of Spinal Anesthesia and Early Postoperative Pain After Arthroscopic ACL Repair?" a Prospective, Randomized, Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT05050656
- Acronym / sponsor ID
- FMASU R 63/ 2021
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 20 Sep 2021 (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.
The purpose of the study is to use duloxetine as premedication in Anterior cruciate ligament repair under spinal anesthesia and evaluate the effect on onset and duration of spinal anesthesia and postoperative pain control.
Detailed description
We designed this randomized, double-blind study to evaluate the effectiveness of administration of oral duloxetine 2 hours preoperatively on the onset and the duration of the spinal anesthesia in arthroscopic anterior cruciate ligament (ACL) repair and the role of duloxetine on postoperative analgesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D (duloxetine group) | Active comparator | Drug: Duloxetine 60mgTwo hours before surgery, participants received oral duloxetine 60 mg tablets in the ward then transferred to OR to receive spinal anesthesia before surgery. |
| Group C (control group) | Placebo comparator | Drug: PlaceboTwo hours before surgery, participants received oral placebo tablets in the ward then transferred to OR to receive spinal anesthesia before surgery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists I or II.
- Sex: Both sexes.
- Age between 18 and 50.
- Height 155-180 cm.
- Patients scheduled for arthroscopic anterior cruciate ligament (ACL) repair under spinal anesthesia.
Key exclusion criteria (12 listed)
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- Had a history of drug or alcohol abuse.
- Taking opioids or sedative medications.
- Inability to communicate with patients to evaluate the postoperative pain.
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 |
|---|---|---|
| Duloxetine 60mgDuloxetine is a selective SNRI prescribed in depression, anxiety, and chronic pain like diabetic neuropathy and fibromyalgia, it acts through central and peripheral pain modulation | Drug | Group D (duloxetine group) |
| Placeboplacebo tablets identical to duloxetine tablets | Drug | Group C (control group) |
Primary outcome
Assess the onset of spinal anesthesia
Time frame: 20 min
Time to T10 sensory block and time to Bromage 1 motor block
3 secondary outcomes
Duration of spinal anesthesia
Time frame: 4 hours
Postoperative pain
Time frame: 24 hours
Time for first postoperative rescue analgesia request, frequency, and total morphine consumption
Time frame: 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 20 Sep 2021.
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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.
tamer abdelaziz, MD principal investigator
Faculty of medicine, Ain Shams University, Cairo, Egypt
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 Duloxetine 60mg in people with Anesthesia, run by Ain Shams University at 1 site 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 5 inclusion and 12 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 20 Sep 2021. 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 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. 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.
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?
Assess the onset of spinal anesthesia (time frame: 20 min). 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 20 Sep 2021.