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This prospective, randomized, double blinded, placebo-controlled study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair with a mesh under general anaesthesia, and how the efficiency of early postoperative analgesia achieved correlates with the risk of developing a chronic pain state, a not uncommon condition after this type of surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transversus abdominis plane block with 20 ml ropivacaine 0,75% | Active Comparator | Transversus abdominis plane block with 20 ml ropivacaine 0,75% |
|
| Transversus abdominis plane block with 20 ml saline | Placebo Comparator | Transversus abdominis plane block with 20 ml saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transversus abdominis plane block | Procedure | ultrasound guided transversus abdominis plane block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores at rest and with movement using the numerical rating scale (NRS) | 3, 6 and 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of chronic pain | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption (mg) | 24 hours postoperatively |
Inclusion Criteria:
ASA I-III patients undergoing inguinal hernia repair with a mesh
age between 18 and 75 years old
ability to read and write greek
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erifyli Argyra, MD, PhD | Aretaieion University Hospital | Study Chair |
| Kassiani Theodoraki, MD, PhD | Aretaieion University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aretaieion University Hospital | Athens | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23160979 | Result | Milone M, Di Minno MN, Musella M, Maietta P, Salvatore G, Iacovazzo C, Milone F. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. 2013 Dec;17(6):749-55. doi: 10.1007/s10029-012-1022-2. Epub 2012 Nov 16. | |
| 23549122 | Result |
| Label | URL |
|---|---|
| THE JOURNAL OF THE NEW YORK SCHOOL OF REGIONAL ANESTHESIA | View source |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D010149 | Pain, Postoperative |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f. |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |