PainPhase 2/3NCT00735124
Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy
A Phase 2/3 study testing Gabapentin in people with Pain and Analgesia, run by University of Oklahoma at 1 site in United States.
Trial summary
The study will investigate the effects of single dose pre-operative oral dose of gabapentin (1200) on post -operative pain scores and oral analgesic requirements. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Analgesia, Hernia, Inguinal
- What is being tested?
- Gabapentin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2008to Sep 2009
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects having elective surgery with open unilateral Inguinal herniorraphy
Who cannot join
- Non elective surgery
- Patients currently on gabapentin therapy
- Patient hypersensitive to gabapentin surgery
- History of alcohol or drug abuse
- Patients who are pregnant or who are nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of Post-Operative Pain Scores and Analgesic Requirements After Ambulatory Inguinal Herniorrhaphy With Pre-Operative Gabapentin Therapy
The study will investigate the effects of single dose pre-operative oral dose of gabapentin (1200) on post -operative pain scores and oral analgesic requirements.
Read the detailed description
The study will benefit patients in reducing post-operative pain scores as well as reduction in oral analgesic consumption. Gabapentin has been shown to reduce post operative pain pain scores in breast surgery, hysterectomy , spinal surgery, orthopedic and thyroid surgery
- Conditions
- Pain, Analgesia, Hernia, Inguinal
- Being tested
- Gabapentin, placebo
- Keywords
- analgesia requirement and post operative pain
- Medical subject headings
- Pain, Agnosia, Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurtonin
1200 mg single dose gabapentin
placeboOther
Injection of placebo/sham
| Study group | Role | What they receive |
|---|---|---|
| Single pre-op dose of Gabapentine | Active comparator | Active treatment with the study drug Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Placebo arm for blinding the medication Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain is reduced when single pre-operative oral dose of Gabapentine is given to the patient before the Inguinal Herniorrhaphy
Post operative pain is reduced when single pre-operative oral dose of
Measured: 1yrs
Secondary outcomes (1)
The post operative analgesia requirement is also reduced
The post operative analgesia requirement is also reduced
Measured: 1yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study start6 Nov 2008
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Changes to surgical practices led to the loss of eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Badie Mansour, MD, Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735124
- Sponsor's protocol ID
- 14002
- Status last verified
- Apr 2017
- First submitted
- 13 Aug 2008
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Post-Operative Pain Scores and Analgesic Requirements After Ambulatory Inguinal Herniorrhaphy With Pre-Operative Gabapentin Therapy
- ClinicalTrials.gov ID
- NCT00735124
- Acronym / sponsor ID
- 14002
- Conditions
- Pain, Analgesia, Hernia, Inguinal
- Keywords
- analgesia requirement and post operative pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changes to surgical practices led to the loss of eligible patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 6 Nov 2008 (actual)
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Aug 2008 (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 will investigate the effects of single dose pre-operative oral dose of gabapentin (1200) on post -operative pain scores and oral analgesic requirements.
Detailed description
The study will benefit patients in reducing post-operative pain scores as well as reduction in oral analgesic consumption. Gabapentin has been shown to reduce post operative pain pain scores in breast surgery, hysterectomy , spinal surgery, orthopedic and thyroid surgery
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 |
|---|---|---|
| Single pre-op dose of Gabapentine | Active comparator | Drug: GabapentinActive treatment with the study drug |
| Placebo | Placebo comparator | Other: placeboPlacebo arm for blinding the medication |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects having elective surgery with open unilateral Inguinal herniorraphy
Key exclusion criteria (5 listed)
- Non elective surgery
- Patients currently on gabapentin therapy
- Patient hypersensitive to gabapentin surgery
- History of alcohol or drug abuse
- Patients who are pregnant or who are nursing
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: Neurtonin1200 mg single dose gabapentin | Drug | Single pre-op dose of Gabapentine |
| placeboInjection of placebo/sham | Other | Placebo |
Primary outcome
Post operative pain is reduced when single pre-operative oral dose of Gabapentine is given to the patient before the Inguinal Herniorrhaphy
Time frame: 1yrs
Post operative pain is reduced when single pre-operative oral dose of
1 secondary outcome
The post operative analgesia requirement is also reduced
Time frame: 1yrs
Results and safety
The study was stopped early (reason given: Changes to surgical practices led to the loss of eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Badie Mansour, MD principal investigator
OUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gabapentin in people with Pain and Analgesia, run by University of Oklahoma at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 28 Apr 2017. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study was stopped early (reason given: Changes to surgical practices led to the loss of eligible patients). 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?
Post operative pain is reduced when single pre-operative oral dose of Gabapentine is given to the patient before the Inguinal Herniorrhaphy (time frame: 1yrs). 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 28 Apr 2017.