Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Transabdominal Preperitoneal repair of inguinal hernia
* Procedure: Transabdominal Preperitoneal repair of inguinal hernia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I-III BMI ≤ 35 Age ≥ 18 Normal coagulation profile Exclusion Criteria: Non-reducible/obstructed hernias Previous open surgery in the lower abdomen Contraindication for pneumoperitoneum Contraindication for spinal or/and general anesthesia History of chronic pain or daily intake of analgesics Psychiatric disorders Inability of patients to use PCA pump

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal anesthesia<br>Transabdominal Preperitoneal repair of inguinal hernia. spinal anesthesia | Procedure: Transabdominal Preperitoneal repair of inguinal hernia<br>* Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia<br>|
| Active Comparator: General Anesthesia<br>Transabdominal Preperitoneal repair of inguinal hernia. general anesthesia | Procedure: Transabdominal Preperitoneal repair of inguinal hernia<br>* Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | The total dose of morphine was calculated as mg and administered by PCA pump | Every 8 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic inguinal hernia repair, TAPP, Spinal Anesthesia, General Anesthesia