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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Transabdominal Preperitoneal repair of inguinal hernia

• Registration Number: NCT01520857
• Lead Sponsor: Larissa University Hospital

Brief Summary

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

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).

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-30
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal anesthesia	Transabdominal Preperitoneal repair of inguinal hernia	Transabdominal Preperitoneal repair of inguinal hernia. spinal anesthesia
General Anesthesia	Transabdominal Preperitoneal repair of inguinal hernia	Transabdominal Preperitoneal repair of inguinal hernia. general anesthesia

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	Every 8 hours	The total dose of morphine was calculated as mg and administered by PCA pump

Secondary Outcome Measures

Name	Time	Method
Quality of life	6 months after the operation	SF 36 questionnaire
Patient satisfaction	2 weeks after the operation
Complications	1 year	seroma, hematoma, infection, recurrence of hernia, etc
Postoperative pain	Every 8 hrs	NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)
Side- effects	Every 8 hrs	To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, shoulder pain, urinary retention, etc
Hospital stay	Patients will be followed for the duration of hospital stay
Chronic Pain	12 months after the operation

Trial Locations

Locations (1)

University Hospital of Larissa; 🇬🇷 Larissa, Greece