Inguinal HerniaPhase 3NCT01450345
Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
A Phase 3 study testing Pregabalin in people with Inguinal Hernia and Postoperative Pain, run by University of Malaya at 1 site in Malaysia.
Trial summary
The study carry out is to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in post-operative pain management. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Inguinal Hernia, Postoperative Pain
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteMalaysia
- Study dates
- Sep 2009to Dec 2011
- Phase
- Phase 3
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of inguinal hernia
- Patient undergo operation under daycare basis
- ASA I-II
- Written consent
Who cannot join
- ASA > II
- Allergic reaction against gabapentin and/or pregabalin
- History of recurrent hernia repair.
- Patient who has taken analgesia prior to the surgery
- Liver failure
- Renal failure
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya
Kuala Lumpur, Kuala Lumpur, 59100
CharngChee Toh, MBBS, MRCS, 60193380337, toh2c79@yahoo.com
CharngChee Toh, MBBS, MRCS
About this study
The study carry out is to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in post-operative pain management.
- Conditions
- Inguinal Hernia, Postoperative Pain
- Being tested
- Pregabalin
- Keywords
- Clinical diagnosis of inguinal hernia, Patient undergo operation under daycare basis, ASA I-II, Written consent
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica 150mg
The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin Group | Experimental | The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study is constructed to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy for post operative pain at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3.
Efficacy: To compare the VAS score for pain after operation between the group at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3.
Measured: 3 days
Secondary outcomes (2)
Opiod Sparing
Total amount of rescue medication requires
Measured: 3 days
Side effect of medication
Severity of Post operative nausea and vomiting (PONV) graded with mild, moderare and severe(Vomiting) Side effect of medication includes headache, giddiness, visual disturbance, and difficulty in walking.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startSep 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toh Charng Chee, University of Malaya
- Investigators
- CharngChee Toh, MBBS, MRCS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450345
- Sponsor's protocol ID
- toh2c79@Pregabalin
- Status last verified
- Oct 2011
- First submitted
- 24 Sep 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
- ClinicalTrials.gov ID
- NCT01450345
- Acronym / sponsor ID
- toh2c79@Pregabalin
- Conditions
- Inguinal Hernia, Postoperative Pain
- Keywords
- Clinical diagnosis of inguinal hernia, Patient undergo operation under daycare basis, ASA I-II, Written consent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 12 Oct 2011 (estimated)
- 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 study carry out is to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in post-operative pain management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregabalin Group | Experimental | Drug: PregabalinThe patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of inguinal hernia
- Patient undergo operation under daycare basis
- ASA I-II
- Written consent
Key exclusion criteria (7 listed)
- ASA > II
- Allergic reaction against gabapentin and/or pregabalin
- History of recurrent hernia repair.
- Patient who has taken analgesia prior to the surgery
- Liver failure
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 |
|---|---|---|
| PregabalinAlso: Lyrica 150mgThe patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction. | Drug | Pregabalin Group |
Primary outcome
Study is constructed to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy for post operative pain at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3.
Time frame: 3 days
Efficacy: To compare the VAS score for pain after operation between the group at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3.
2 secondary outcomes
Opiod Sparing
Time frame: 3 days
Side effect of medication
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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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.
CharngChee Toh, MBBS, MRCS principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin in people with Inguinal Hernia and Postoperative Pain, run by University of Malaya at 1 site in Malaysia.
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: status not confirmed, as of the sponsor's last update on 12 Oct 2011. 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 Malaysia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact CharngChee Toh, MBBS, MRCS (60193380337, toh2c79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study is constructed to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy for post operative pain at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3. (time frame: 3 days). 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 12 Oct 2011.