Inguinal HerniaPhase 3Trigger-openNCT02065219
Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair
A Phase 3 study testing Bupivacaine in people with Inguinal Hernia and Chronic Pain, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Groin hernia repair is a common procedure performed in approximately 2,000 patients per one million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the patients indicating that a large number of patients each year suffer from debilitating reduction in health-related quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Chronic Pain
- What is being tested?
- Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to May 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with persistent pain (< 6 mo) after open groin hernia repair
- Patients with maximal pain area 3 cm or less from the superficial inguinal ring
- Patients living in the Capital Region of Denmark (Region Hovedstaden) or the Region of Zealand (Region Sjælland)
Who cannot join
- Known allergy to bupivacaine or other local anesthetics of amide-type
- Declared incapable of making his/hers own affairs
- Does not comprehend Danish in the written or spoken language
- Cognitive impairment to a degree influencing the testing reliability
- Known recurrence of the inguinal hernia
- Other surgical procedures performed in the groin or on the external genitals
Show all 9Show fewer
- Neuropathy affecting the groin region caused by other conditions, e.g. post-stroke, multiple sclerosis, herniated intervertebral disc
- Abuse of alcohol or drugs
- Unable to cooperate with the sensory examinations
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK
Copenhagen, 2100
About this study
Groin hernia repair is a common procedure performed in approximately 2,000 patients per one million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the patients indicating that a large number of patients each year suffer from debilitating reduction in health-related quality of life.
This study examines the effect of ultra-sound guided blocks with local anesthesia in the groin in regard to pain relief and sleep quality.
The hypothesis of the study is that a block will confer significant pain relief to patients with severe chronic pain following open groin hernia repair.
Read the detailed description
This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after open groin hernia, examines the effect of an ultra-sound guided local anesthetic block of a trigger-point, situated near the spermatic cord at the superficial inguinal ring. In order to compare effects and distribution of the blocks in patients vs. healthy subjects, the block is tested and examined in volunteers using a similar methodology.
- Conditions
- Inguinal Hernia, Chronic Pain
- Being tested
- Bupivacaine, Placebo
- Keywords
- Chronic Pain, Inguinal Hernia, Outcome, Surgical Procedure, Operative
- Medical subject headings
- Hernia, Inguinal, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Bupivacain "SAD"
10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord
PlaceboDrug
Also called Normal saline
10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | injection, 25 mg, once, 5 min Receives: Drug: Bupivacaine |
| Placebo | Placebo comparator | injection, 10 ml 0.9% sodium chloride, once, 5 min Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalized summed pain intensity difference (SPID)
The number of patients with normalized summed pain intensity differences (SPID) of more or equal to 50% after bupivacaine AND SPID less or equal to 25% after placebo.
Measured: 20 min
Secondary outcomes (6)
Thermal thresholds
Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo
Measured: 20 min
Suprathreshold heat stimulation
Quantitative changes in pain ratings to suprathreshold heat stimulation after bupivacaine compared to placebo
Measured: 20 min
Pressure pain thresholds
Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo
Measured: 20 min
Sensory mapping
Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo
Measured: 20 min
Pain questionnaire
Quantitative changes in summed pain intensity differences (SPIDs) during rest, movement and during auto-palpation, assessed morning and evening after bupivacaine compared to placebo
Measured: 7 days
Sleep quality
Quantitative changes in sleep quality assessed each morning, after bupivacaine compared to placebo
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, mads u werner, University of Copenhagen
- Investigators
- Mads U Werner, MD, Principal investigator, Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospital, DENMARKHenrik Kehlet, MD, Study director, Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065219
- Sponsor's protocol ID
- H-3-2011-130-open
- Other IDs
- 2612-1006
- Acronym
- Trigger-open
- Status last verified
- Nov 2016
- First submitted
- 14 Feb 2014
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wijayasinghe N, Ringsted TK, Bischoff JM, Kehlet H, Werner MU. The role of peripheral afferents in persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled, crossover trial of ultrasound-guided tender point blockade. Br J Anaesth. 2016 Jun;116(6):829-37. doi: 10.1093/bja/aew071.
PubMed 27199314
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair
- ClinicalTrials.gov ID
- NCT02065219
- Acronym / sponsor ID
- Trigger-open / H-3-2011-130-open
- Conditions
- Inguinal Hernia, Chronic Pain
- Keywords
- Chronic Pain, Inguinal Hernia, Outcome, Surgical Procedure, Operative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Feb 2014 (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.
Groin hernia repair is a common procedure performed in approximately 2,000 patients per one million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the patients indicating that a large number of patients each year suffer from debilitating reduction in health-related quality of life.
This study examines the effect of ultra-sound guided blocks with local anesthesia in the groin in regard to pain relief and sleep quality.
The hypothesis of the study is that a block will confer significant pain relief to patients with severe chronic pain following open groin hernia repair.
Detailed description
This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after open groin hernia, examines the effect of an ultra-sound guided local anesthetic block of a trigger-point, situated near the spermatic cord at the superficial inguinal ring. In order to compare effects and distribution of the blocks in patients vs. healthy subjects, the block is tested and examined in volunteers using a similar methodology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: Bupivacaineinjection, 25 mg, once, 5 min |
| Placebo | Placebo comparator | Drug: Placeboinjection, 10 ml 0.9% sodium chloride, once, 5 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with persistent pain (< 6 mo) after open groin hernia repair
- Patients with maximal pain area 3 cm or less from the superficial inguinal ring
- Patients living in the Capital Region of Denmark (Region Hovedstaden) or the Region of Zealand (Region Sjælland)
Key exclusion criteria (9 listed)
- Known allergy to bupivacaine or other local anesthetics of amide-type
- Declared incapable of making his/hers own affairs
- Does not comprehend Danish in the written or spoken language
- Cognitive impairment to a degree influencing the testing reliability
- Known recurrence of the inguinal hernia
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 |
|---|---|---|
| BupivacaineAlso: Bupivacain "SAD"10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord | Drug | Bupivacaine |
| PlaceboAlso: Normal saline10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord | Drug | Placebo |
Primary outcome
Normalized summed pain intensity difference (SPID)
Time frame: 20 min
The number of patients with normalized summed pain intensity differences (SPID) of more or equal to 50% after bupivacaine AND SPID less or equal to 25% after placebo.
6 secondary outcomes
Thermal thresholds
Time frame: 20 min
Suprathreshold heat stimulation
Time frame: 20 min
Pressure pain thresholds
Time frame: 20 min
Sensory mapping
Time frame: 20 min
Pain questionnaire
Time frame: 7 days
Sleep quality
Time frame: 7 days
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 28 Nov 2016.
- Results publication: PubMed 27199314Wijayasinghe N, Ringsted TK, Bischoff JM, Kehlet H, Werner MU. The role of peripheral afferents in persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled, crossover trial of ultrasound-guided tender point blockade. Br J Anaesth. 2016 Jun;116(6):829-37. doi: 10.1093/bja/aew071.
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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.
Mads U Werner, MD principal investigator
Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospital, DENMARK
Henrik Kehlet, MD study director
Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK
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 Bupivacaine in people with Inguinal Hernia and Chronic Pain, run by University of Copenhagen 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 3 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 28 Nov 2016. 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. 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 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?
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?
Normalized summed pain intensity difference (SPID) (time frame: 20 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02065219, which also lists 1 linked publication.
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 Nov 2016.