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

Larissa University Hospital

Status: Completed

Conditions: Postoperative Pain

Treatments: Procedure: Transabdominal Preperitoneal repair of inguinal hernia

Study type: Interventional

Funder types: Other

Identifiers

NCT01520857

UTH5535/12/11

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Spinal anesthesia

Active Comparator group

Description:

Transabdominal Preperitoneal repair of inguinal hernia. spinal anesthesia

Treatment:

Procedure: Transabdominal Preperitoneal repair of inguinal hernia

Procedure: Transabdominal Preperitoneal repair of inguinal hernia

General Anesthesia

Active Comparator group

Description:

Transabdominal Preperitoneal repair of inguinal hernia. general anesthesia

Treatment:

Procedure: Transabdominal Preperitoneal repair of inguinal hernia

Procedure: Transabdominal Preperitoneal repair of inguinal hernia