Chronic Pain
Conditions
Keywords
Herniorrhaphy, Surgical Equipment, Chronic Pain, Inguinal Herniorrhaphy, Laparoscopy, Surgical Outcome
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.
Interventions
DRUGBupivacaine
injection, once, 5 min
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalized summed pain intensity differences (SPID) | 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
| Measure | Time frame | Description |
|---|---|---|
| Thermal thresholds | 20 min | Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo |
| Pressure pain thresholds | 20 min | Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo |
| Suprathreshold heat stimulation | 20 min | Quantitative changes in pain rating to suprathreshold heat stimulation after bupivacaine compared to placebo |
| Pain questionnaire | 7 days | Quantitative changes in summed pain intensity differences (SPIDs) assessed morning and evening after bupivacaine compared to placebo |
| Sleep quality questionnaire | 7 days | Quantitative changes in sleep quality assessed each morning after bupivacaine compared to placebo |
| Sensory mapping | 20 min | Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo |
Countries
Denmark
Outcome results
None listed