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Chronic PainPhase 3Trigger-lapNCT02065804

Trigger-point Blockade in Persistent Pain After Laparoscopical Groin Hernia Repair

A Phase 3 study testing Bupivacaine in people with Chronic Pain, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 older
Conditions the study is for
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
14 participants
Where
1 siteDenmark
Study dates
Oct 2013to Jul 2014
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with persistent pain (< 6 mo) after laparoscopical 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 writing or speech
  • 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

Other trials in Denmark

About this study

Official title: Trigger-point Blockade in Persistent Pain After Laparoscopically Assisted Groin Hernia Repair

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 laparoscopical groin hernia repair.

Read the detailed description

This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after laparoscopically assisted groin hernia repair, 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.

Conditions
Chronic Pain
Being tested
Bupivacaine
Keywords
Herniorrhaphy, Surgical Equipment, Chronic Pain, Inguinal Herniorrhaphy, Laparoscopy, Surgical Outcome
Medical subject headings
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", 0.9% Sodium-chloride

    injection, once, 5 min

Study groups in NCT02065804
Study groupRoleWhat they receive
Active drugExperimental10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord
Receives: Drug: Bupivacaine
PlaceboPlacebo comparator10 ml of normal saline deposited by ultra-sound guidance around the spermatic cord
Receives: Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Normalized summed pain intensity differences (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)

  1. Thermal thresholds

    Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo

    Measured: 20 min

  2. Suprathreshold heat stimulation

    Quantitative changes in pain rating to suprathreshold heat stimulation after bupivacaine compared to placebo

    Measured: 20 min

  3. Pressure pain thresholds

    Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo

    Measured: 20 min

  4. Sensory mapping

    Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo

    Measured: 20 min

  5. Pain questionnaire

    Quantitative changes in summed pain intensity differences (SPIDs) assessed morning and evening after bupivacaine compared to placebo

    Measured: 7 days

  6. Sleep quality questionnaire

    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.

  1. First posted19 Feb 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02065804
Sponsor's protocol ID
H-3-2011-130-lap
Acronym
Trigger-lap
Status last verified
Oct 2017
First submitted
15 Feb 2014
Last updated
18 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Data will be submitted as supplementary material in the final manuscript

Publications

  • Linderoth G, Kehlet H, Aasvang EK, Werner MU. Neurophysiological characterization of persistent pain after laparoscopic inguinal hernia repair. Hernia. 2011 Oct;15(5):521-9. doi: 10.1007/s10029-011-0815-z. Epub 2011 Apr 9.

    PubMed 21479588

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bupivacaine in people with 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 18 Oct 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 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 differences (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 NCT02065804, 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 18 Oct 2017.

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