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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 laparoscopical groin hernia repair.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active drug | Experimental | 10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord |
|
| Placebo | Placebo Comparator | 10 ml of normal saline deposited by ultra-sound guidance around the spermatic cord |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | injection, once, 5 min |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normalized summed pain intensity differences (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 Werner | Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospital, DENMARK | Principal Investigator |
| Henrik Kehlet, MD, DMSc | Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21479588 | Background | 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. |
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Data will be submitted as supplementary material in the final manuscript
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Quantitative changes in pain rating 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) assessed morning and evening after bupivacaine compared to placebo | 7 days |
| Sleep quality questionnaire | Quantitative changes in sleep quality assessed each morning after bupivacaine compared to placebo | 7 days |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |