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| Name | Class |
|---|---|
| University of Thessaly | OTHER |
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The purpose of the study is to assess whether spinal anesthesia is superior to the standard general anesthesia or not for patients undergoing transabdominal preperitoneal inguinal hernia repair (TAPP).
Anesthesia for laparoscopic procedures, including transabdominal preperitoneal inguinal hernia repair(TAPP) is synonymous with general anesthesia because of the adverse effects of the CO2 pneumoperitoneum on the awake patient, and regional anesthesia is preferred only in patients where general anesthesia is contraindicated. Α pilot study of our hospital has recently shown the feasibility to perform successfully and safely transabdominal preperitoneal inguinal hernia repair with low pressure CO2 pneumoperitoneum under spinal anesthesia.After this pilot study and based on previous experience in regional anesthesia for laparoscopic procedures, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for patients undergoing transabdominal preperitoneal inguinal hernia repair (TAPP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal anesthesia | Active Comparator | Transabdominal Preperitoneal repair of inguinal hernia. spinal anesthesia |
|
| General Anesthesia | Active Comparator | Transabdominal Preperitoneal repair of inguinal hernia. general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transabdominal Preperitoneal repair of inguinal hernia | Procedure | Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative opioid consumption | The total dose of morphine was calculated as mg and administered by PCA pump | Every 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain) | Every 8 hrs |
| Side- effects | To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, shoulder pain, urinary retention, etc |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chamaidi Sarakatsianou, RN,MSc | University Hospital of Larissa | Principal Investigator |
| George Tzovaras, MD | University Hospital of Larissa | Study Chair |
| George Tzovaras, MD | University Hospital of Larissa | Study Director |
| Stavroula Georgopoulou, MD | University Hospital of Larissa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Larissa | Larissa | 41100 | Greece |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Transabdominal Preperitoneal repair of inguinal hernia | Procedure | Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under general anesthesia |
|
| Every 8 hrs |
| Hospital stay | Patients will be followed for the duration of hospital stay |
| Patient satisfaction | 2 weeks after the operation |
| Chronic Pain | 12 months after the operation |
| Quality of life | SF 36 questionnaire | 6 months after the operation |
| Complications | seroma, hematoma, infection, recurrence of hernia, etc | 1 year |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |