Primary HyperalgesiaNCT00583180
Sensory Function After Wound Instillation of Capsaicin
An observational study of Primary Hyperalgesia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The use of capsaicin as a potential analgesic drug for postoperative pain relies on the ability of capsaicin to induce membrane lysis of c-nerve fibers. In a previous randomized placebo controled blinded study of this effect we found a significant effect of capsaicin versus placebo. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Primary Hyperalgesia
- What is being tested?
- Capsaicin
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Jan 2008
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult males with primary unilateral groin hernia
Who may be able to join
- Primary groin hernia planned to undergo Lichtenstein mesh repair
- Ability to use pain scales
- American Society of Anesthesiologist class I or II based upon medical history, physical examination, and screening laboratory results
- Willing to take oral pain medication (acetaminophen, ibuprofen) for the first week
- Willing to fill out a diary for four weeks following surgery.
Who cannot join
- A previous lower abdominal surgical procedure
- Bupivacaine, acetaminophen, ibuprofen, or tramadol
- A medical condition likely to alter wound healing or pain ratings
- Systolic blood pressure greater than 150 or diastolic greater than 95 mm Hg
- Contraindication to general anesthesia
- Bilateral hernia repair
Show all 9Show fewer
- A history of drug or alcohol abuse within the past two years
- Use of antihypertensive, antidepressant, or psychotropic drug that has not been stable for 3 months
- Use of an investigational drug within 3 months or scheduled to receive an investigational drug other than ALGRX 4975 during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cutaneous Sensory Function After Wound Instillation of Capsaicin During Groin Hernia Repair
The use of capsaicin as a potential analgesic drug for postoperative pain relies on the ability of capsaicin to induce membrane lysis of c-nerve fibers. In a previous randomized placebo controled blinded study of this effect we found a significant effect of capsaicin versus placebo. Before surgery all patients were examined by quantitative sensory testing to evaluate sensory function. In this study an identical sensory testing will examine if changes to the sensory function in capsaicin treated patients is identical to placebo treated patients.No new intervention will be performed
- Conditions
- Primary Hyperalgesia
- Being tested
- Capsaicin
- Keywords
- Primary and/or secondary hyperalgesia, hypoesthesia
- Medical subject headings
- Hyperalgesia, Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
Also called ALGRX 4975, ADLEA
instillation of sterile water or 1000 micrograms of capsaicin into the wound at the end of open groin hernia surgery in previous study.no new intervention will be performed in the current study.
| Study group | Role | What they receive |
|---|---|---|
| A | Capsaicin treated patients Receives: Drug: Capsaicin | |
| P | Placebo treated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in sensory function before and 2 years after groin hernia repair in patients with and without capsaicin instillation, evaluated by quantitative sensory testing
Measured: 2 years
Secondary outcomes (1)
Frequency of chronic pain
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperalgesiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Henrik Kehlet, M.D, Ph. D., Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583180
- Sponsor's protocol ID
- 4975-2008-01
- Status last verified
- Jan 2008
- First submitted
- 20 Dec 2007
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Sensory Function After Wound Instillation of Capsaicin During Groin Hernia Repair
- ClinicalTrials.gov ID
- NCT00583180
- Acronym / sponsor ID
- 4975-2008-01
- Conditions
- Primary Hyperalgesia
- Keywords
- Primary and/or secondary hyperalgesia, hypoesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2008
- Study completion
- Jan 2008 (actual)
- First posted
- 31 Dec 2007 (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 use of capsaicin as a potential analgesic drug for postoperative pain relies on the ability of capsaicin to induce membrane lysis of c-nerve fibers. In a previous randomized placebo controled blinded study of this effect we found a significant effect of capsaicin versus placebo. Before surgery all patients were examined by quantitative sensory testing to evaluate sensory function. In this study an identical sensory testing will examine if changes to the sensory function in capsaicin treated patients is identical to placebo treated patients.No new intervention will be performed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: CapsaicinCapsaicin treated patients |
| P | – | –Placebo treated patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males with primary unilateral groin hernia
Key inclusion criteria (5 listed)
- Primary groin hernia planned to undergo Lichtenstein mesh repair
- Ability to use pain scales
- American Society of Anesthesiologist class I or II based upon medical history, physical examination, and screening laboratory results
- Willing to take oral pain medication (acetaminophen, ibuprofen) for the first week
- Willing to fill out a diary for four weeks following surgery.
Key exclusion criteria (9 listed)
- A previous lower abdominal surgical procedure
- Bupivacaine, acetaminophen, ibuprofen, or tramadol
- A medical condition likely to alter wound healing or pain ratings
- Systolic blood pressure greater than 150 or diastolic greater than 95 mm Hg
- Contraindication to general anesthesia
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 |
|---|---|---|
| CapsaicinAlso: ALGRX 4975, ADLEAinstillation of sterile water or 1000 micrograms of capsaicin into the wound at the end of open groin hernia surgery in previous study.no new intervention will be performed in the current study. | Drug | A |
Primary outcome
changes in sensory function before and 2 years after groin hernia repair in patients with and without capsaicin instillation, evaluated by quantitative sensory testing
Time frame: 2 years
1 secondary outcome
Frequency of chronic pain
Time frame: 2 years
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 30 Jan 2008.
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.
Henrik Kehlet, M.D, Ph. D. study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperalgesia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 inclusion and 9 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 30 Jan 2008. 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 Denmark. 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.
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?
changes in sensory function before and 2 years after groin hernia repair in patients with and without capsaicin instillation, evaluated by quantitative sensory testing (time frame: 2 years). 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 30 Jan 2008.