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Completed

NCT Number: NCT02065219

Trigger-point Blockade in Persistent Pain After Open 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 open groin hernia repair.

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Key information

Conditions

Inguinal Hernia Chronic Pain Hernia Hernia, Abdominal Hernia, Inguinal Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Bupivacaine

Drug

10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord

Other names: Bupivacain "SAD"

Placebo

Drug

10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord

Other names: Normal saline

Primary outcomes

  1. 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.

Secondary outcomes

  1. Thermal thresholds

    Time frame: 20 min

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

  2. Suprathreshold heat stimulation

    Time frame: 20 min

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

  3. Pressure pain thresholds

    Time frame: 20 min

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

  4. Sensory mapping

    Time frame: 20 min

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

  5. Pain questionnaire

    Time frame: 7 days

    Quantitative changes in summed pain intensity differences (SPIDs) during rest, movement and during auto-palpation, assessed morning and evening after bupivacaine compared to placebo

  6. Sleep quality

    Time frame: 7 days

    Quantitative changes in sleep quality assessed each morning, after bupivacaine compared to placebo

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Acronym: Trigger-open

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Feb 17, 2014
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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