Pain, PostoperativeEarly Phase 1NCT05533684
A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries
A Early Phase 1 study testing Gabapentin in people with Pain, Postoperative, run by Minia University at 1 site in Egypt.
Trial summary
Single dose 600 mg gabapentin will be given preoperatively in anal surgeries Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 31 Dec 2022
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I or II
- Aged from 18 to 65 years
- Scheduled for anal surgeries at Minya University Hospital
Who cannot join
- Presence of contraindications to neuraxial anesthesia
- Presence of history of central nervous system or mental disorders, epilepsy, chronic pain, or drug abuse.
- The use of neuropathic analgesic or antiepileptic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Single dose 600 mg gabapentin will be given preoperatively in anal surgeries
Read the detailed description
Patients will be grouped into 2 groups of 25 patients each, the first group will receive 600 mg of gabapentin one hour before surgery and the second group will receive a placebo tablet. pain scores will be measured postoperatively
- Conditions
- Pain, Postoperative
- Being tested
- Gabapentin
- Keywords
- anal surgery,, gabapentin,, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Gaptin 600 mg
single preoperative dose of 600 mg gabapentin
| Study group | Role | What they receive |
|---|---|---|
| postoperative pain | No intervention | Measuring postoperative pain using the visual analogue scale |
| total analgesic consumption | Other | Recording the total amount of analgesia consumed by the patients Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
measuring postoperative pain using the visual analog scale from 0 to 10, where zero is the least, and 10 is the worst pain
Measured: first 12 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Minia 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups are included in the study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Mohamed Aly Omar Mousa, Minia University
- Investigators
- Sarah Omar, M.D., Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533684
- Sponsor's protocol ID
- 343-2022
- Status last verified
- Mar 2023
- First submitted
- 3 Sep 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research will be available to other researchers when it is completed
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries
- ClinicalTrials.gov ID
- NCT05533684
- Acronym / sponsor ID
- 343-2022
- Conditions
- Pain, Postoperative
- Keywords
- anal surgery,, gabapentin,, postoperative pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 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.
Single dose 600 mg gabapentin will be given preoperatively in anal surgeries
Detailed description
Patients will be grouped into 2 groups of 25 patients each, the first group will receive 600 mg of gabapentin one hour before surgery and the second group will receive a placebo tablet. pain scores will be measured postoperatively
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2 groups are included in the study
| Arm | Type | Receives |
|---|---|---|
| postoperative pain | No intervention | –Measuring postoperative pain using the visual analogue scale |
| total analgesic consumption | Other | Drug: GabapentinRecording the total amount of analgesia consumed by the patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I or II
- Aged from 18 to 65 years
- Scheduled for anal surgeries at Minya University Hospital
Key exclusion criteria (3 listed)
- Presence of contraindications to neuraxial anesthesia
- Presence of history of central nervous system or mental disorders, epilepsy, chronic pain, or drug abuse.
- The use of neuropathic analgesic or antiepileptic drugs
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 |
|---|---|---|
| GabapentinAlso: Gaptin 600 mgsingle preoperative dose of 600 mg gabapentin | Drug | total analgesic consumption |
Primary outcome
postoperative pain
Time frame: first 12 hours postoperative
measuring postoperative pain using the visual analog scale from 0 to 10, where zero is the least, and 10 is the worst pain
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 16 Mar 2023.
- Individual participant dataSharing planned: No. The research will be available to other researchers when it is completed
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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.
Sarah Omar, M.D. principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gabapentin in people with Pain, Postoperative, run by Minia 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 3 inclusion and 3 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 16 Mar 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 pain (time frame: first 12 hours postoperative). 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 16 Mar 2023.