AnesthesiaPhase 4NCT05071118
The Efficacy of Pregabalin on the Duration of the Spinal Anesthesia and the Early Postoperative Pain After Total Knee Arthroplasty
A Phase 4 study testing Pregabalin 150mg in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
the purpose of this study is to evaluate the effectiveness of administration of pregabalin 2 hours preoperatively on the onset and the duration of the spinal anesthesia in total knee arthroplasty and the role of pregabalin in postoperative analgesia. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Pregabalin 150mg
- 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
- 21 Mar 2021to 25 Aug 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the ages of 40 and 70 years
- height 155-170 cm
- American Society of Anesthesiologists grade I or II .
- patients underwent total knee arthroplasty under spinal anesthesia
Who cannot join
- patients known to be allergic to any medicines.
- patients had a history of drug or alcohol abuse.
- patients were taking opioids or sedative medications,
- patients Inability to communicate with investigators to evaluate the postoperative pain
- patients were in need for postoperative ICU hospitalization .
- patients had a history of psychiatric conditions.
- Patients with a history of taking pregabalin or gabapentin .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Adding Pregabalin on the Onset and the Duration of Spinal Anesthesia and on the Postoperative Analgesia
the purpose of this study is to evaluate the effectiveness of administration of pregabalin 2 hours preoperatively on the onset and the duration of the spinal anesthesia in total knee arthroplasty and the role of pregabalin in postoperative analgesia.
- Conditions
- Anesthesia
- Being tested
- Pregabalin 150mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery
PlaceboDrug
The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .
| Study group | Role | What they receive |
|---|---|---|
| pregabalin group | Active comparator | Two hours before surgery, the pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery. Receives: Drug: Pregabalin 150mg |
| placebo group | Active comparator | The patients received placebo capsules 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.
onset of spinal anaesthesia
seventy participants undergoing elective total knee arthroplasty under spinal anesthesia half of them took placebo and the other half took 150 mg pregabalin two hours before the procedure and calculate the time from the base line to the onset of anesthesia.
Our primary outcome is to assess the onset of spinal anesthesia.
to detect the onset of spinal anaesthesia
Measured: three months
Secondary outcomes (3)
recovery time
Recovery time from the sensory blockade (2-dermatome regression of anesthesia from the maximum level).
Measured: three months
motor block duration
the time for return to Bromag 2 (the patient is able to move knees and ankles).
Measured: three months
postoperative analgesia
- Postoperative pain will be assessed by the patient using the visual analog scale in the first 24 hour(VAS, 0=no pain; 10=worst possible pain) every 2 hours up to 24 hours after the operation.
Measured: three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start21 Mar 2021
- Primary completion15 Aug 2021
- Study completion25 Aug 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
- Treatment
- 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, Ismail Mohammed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071118
- Sponsor's protocol ID
- FMASU R71/2021
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2021
- Last updated
- 8 Oct 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 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Adding Pregabalin on the Onset and the Duration of Spinal Anesthesia and on the Postoperative Analgesia
- ClinicalTrials.gov ID
- NCT05071118
- Acronym / sponsor ID
- FMASU R71/2021
- 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
- 21 Mar 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 8 Oct 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 this study is to evaluate the effectiveness of administration of pregabalin 2 hours preoperatively on the onset and the duration of the spinal anesthesia in total knee arthroplasty and the role of pregabalin in postoperative analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregabalin group | Active comparator | Drug: Pregabalin 150mgTwo hours before surgery, the pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery. |
| placebo group | Active comparator | Drug: PlaceboThe patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery . |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the ages of 40 and 70 years
- height 155-170 cm
- American Society of Anesthesiologists grade I or II .
- patients underwent total knee arthroplasty under spinal anesthesia
Key exclusion criteria (7 listed)
- patients known to be allergic to any medicines.
- patients had a history of drug or alcohol abuse.
- patients were taking opioids or sedative medications,
- patients Inability to communicate with investigators to evaluate the postoperative pain
- patients were in need for postoperative ICU hospitalization .
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 patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery | Drug | pregabalin group |
| PlaceboThe patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery . | Drug | placebo group |
Primary outcome
onset of spinal anaesthesia
Time frame: three months
seventy participants undergoing elective total knee arthroplasty under spinal anesthesia half of them took placebo and the other half took 150 mg pregabalin two hours before the procedure and calculate the time from the base line to the onset of anesthesia. Our primary outcome is to assess the onset of spinal anesthesia. to detect the onset of spinal anaesthesia
3 secondary outcomes
recovery time
Time frame: three months
motor block duration
Time frame: three months
postoperative analgesia
Time frame: three months.
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 8 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pregabalin 150mg 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 4 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 8 Oct 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. 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?
onset of spinal anaesthesia (time frame: three months). 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 8 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.