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| ID | Type | Description | Link |
|---|---|---|---|
| 2612-1006 | Other Identifier | Danish Medicines Agency |
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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Experimental | injection, 25 mg, once, 5 min |
|
| Placebo | Placebo Comparator | injection, 10 ml 0.9% sodium chloride, once, 5 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 min |
| Measure | Description | Time Frame |
|---|---|---|
| Thermal thresholds | Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo | 20 min |
| Suprathreshold heat stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mads U Werner, MD | Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospital, DENMARK | Principal Investigator |
| Henrik Kehlet, MD | Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27199314 | Result | 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. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo | Drug | 10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord |
|
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Quantitative changes in pain ratings to suprathreshold heat stimulation after bupivacaine compared to placebo
| 20 min |
| Pressure pain thresholds | Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo | 20 min |
| Sensory mapping | Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo | 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 | 7 days |
| Sleep quality | Quantitative changes in sleep quality assessed each morning, after bupivacaine compared to placebo | 7 days |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |