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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord
10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord
Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK
Copenhagen, Denmark
Normalized summed pain intensity difference (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.
Time frame: 20 min
Thermal thresholds
Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo
Time frame: 20 min
Suprathreshold heat stimulation
Quantitative changes in pain ratings to suprathreshold heat stimulation after bupivacaine compared to placebo
Time frame: 20 min
Pressure pain thresholds
Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo
Time frame: 20 min
Sensory mapping
Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo
Time frame: 20 min
Pain questionnaire
Quantitative changes in summed pain intensity differences (SPIDs) during rest, movement and during auto-palpation, assessed morning and evening after bupivacaine compared to placebo
Time frame: 7 days
Sleep quality
Quantitative changes in sleep quality assessed each morning, after bupivacaine compared to placebo
Time frame: 7 days
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