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

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

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Transabdominal Preperitoneal repair of inguinal hernia; Procedure: Transabdominal Preperitoneal repair of inguinal hernia

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Larissa, Greece, 41100
    • University Hospital Of Larissa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Larissa University Hospital
• Collaborators: University of Thessaly
• Investigators: Principal Investigator: Chamaidi Sarakatsianou, RN,MSc, University Hospital Of Larissa; Study Director: George Tzovaras, MD, University Hospital Of Larissa; Study Director: Stavroula Georgopoulou, MD, University Hospital Of Larissa

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 19, 2012
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: General Anesthesia; Spinal Anesthesia; Laparoscopic inguinal hernia repair; TAPP
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: UTH5535/12/11