Acute Postoperative PainNCT04775992
Preemptive Analgesia of Gabapentoids in Orthopedic Surgery
An observational study of Acute Postoperative Pain, run by King Saud University.
Trial summary
To address the preemptive analgesic effect of preoperative gabapentoids versus no gabapentoids in orthopedic surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Postoperative Pain
- What is being tested?
- gabapentoids
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all included RCT
Who may be able to join
- RCT, during last 10 years, involving orthopedic surgery
Who cannot join
- non randomized trials, unavailable study data
About this study
Official title: Preemptive Analgesia of Gabapentoids After Major Orthopedic Surgery: Systematic Review and Meta Analysis
To address the preemptive analgesic effect of preoperative gabapentoids versus no gabapentoids in orthopedic surgery
Read the detailed description
Computer search for all studies used preoperative gabapentoids versus no gabapentoids in orthopedic surgery during the last 10 years (from 2011 - 2020)
- Conditions
- Acute Postoperative Pain
- Being tested
- gabapentoids
- Keywords
- acute postoperative pain, Preemptive analgesia, Orthopedic surgery, Preoperative gabapentoids
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentoidsOther
Preemptive analgesia
| Study group | Role | What they receive |
|---|---|---|
| preemptive group | patients in this group will receive preoperative gabapentoids Receives: Other: gabapentoids | |
| control group | patients in this group will not receive gabapentoids Receives: Other: gabapentoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score on rest
Pain score by VAS on rest
Measured: every hour for the first 24 hours
Postoperative pain during movement
Pain score by VAS during movements
Measured: every hour for the first 24 hours
Secondary outcomes (4)
Worst pain score
Highest pain score
Measured: during the first 24 hours
Least pain score
Lowest pain score
Measured: during the first 24 hours
Time spend in severe pain
how many hours the patients complaint of severe pain
Measured: during the first 24 hours
Patient's satisfaction
Satisfaction by the quality of analgesia
Measured: during the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Postoperative 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SALAH EL-TALLAWY, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775992
- Sponsor's protocol ID
- KSU
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- 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 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesia of Gabapentoids After Major Orthopedic Surgery: Systematic Review and Meta Analysis
- ClinicalTrials.gov ID
- NCT04775992
- Acronym / sponsor ID
- KSU
- Conditions
- Acute Postoperative Pain
- Keywords
- acute postoperative pain, Preemptive analgesia, Orthopedic surgery, Preoperative gabapentoids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 1 Mar 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.
To address the preemptive analgesic effect of preoperative gabapentoids versus no gabapentoids in orthopedic surgery
Detailed description
Computer search for all studies used preoperative gabapentoids versus no gabapentoids in orthopedic surgery during the last 10 years (from 2011 - 2020)
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preemptive group | – | Other: gabapentoidspatients in this group will receive preoperative gabapentoids |
| control group | – | Other: gabapentoidspatients in this group will not receive gabapentoids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all included RCT
Key inclusion criteria (1 listed)
- RCT, during last 10 years, involving orthopedic surgery
Key exclusion criteria (1 listed)
- non randomized trials, unavailable study data
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 |
|---|---|---|
| gabapentoidsPreemptive analgesia | Other | control group, preemptive group |
Primary outcome
Postoperative pain score on rest
Time frame: every hour for the first 24 hours
Pain score by VAS on rest
Postoperative pain during movement
Time frame: every hour for the first 24 hours
Pain score by VAS during movements
4 secondary outcomes
Worst pain score
Time frame: during the first 24 hours
Least pain score
Time frame: during the first 24 hours
Time spend in severe pain
Time frame: during the first 24 hours
Patient's satisfaction
Time frame: during the first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Postoperative Pain, run by King Saud University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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 score on rest (time frame: every hour for the first 24 hours). 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 1 Mar 2021.