Clinical trial NCT02065219: Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair
Official title: Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inguinal Hernia
Chronic Pain
Keywords: Chronic Pain
Inguinal Hernia
Outcome
Surgical Procedure, Operative
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2014-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Normalized summed pain intensity difference (SPID)
timeFrame: 20 min
Secondary outcomes:
measure: Thermal thresholds
timeFrame: 20 min
measure: Suprathreshold heat stimulation
timeFrame: 20 min
measure: Pressure pain thresholds
timeFrame: 20 min
measure: Sensory mapping
timeFrame: 20 min
measure: Pain questionnaire
timeFrame: 7 days
measure: Sleep quality
timeFrame: 7 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK
Study officials:
affiliation: Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospital, DENMARK
name: Mads U Werner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK
name: Henrik Kehlet, MD
role: STUDY_DIRECTOR
References:
citation: 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.