Clinical trial NCT02065804: Trigger-point Blockade in Persistent Pain After Laparoscopical Groin Hernia Repair
Official title: Trigger-point Blockade in Persistent Pain After Laparoscopically Assisted Groin Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: Herniorrhaphy
Surgical Equipment
Chronic Pain
Inguinal Herniorrhaphy
Laparoscopy
Surgical Outcome
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 laparoscopical groin hernia repair.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

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 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
* 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 differences (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 questionnaire
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 Werner
role: PRINCIPAL_INVESTIGATOR
affiliation: Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK
name: Henrik Kehlet, MD, DMSc
role: STUDY_CHAIR
References:
citation: 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.