Skip to main content
OpenTrials
Completed

NCT Number: NCT01520857

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Larissa

Larissa, 41100, Greece

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transabdominal Preperitoneal repair of inguinal hernia

Procedure

Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia

Primary outcomes

  1. Postoperative opioid consumption

    Time frame: Every 8 hours

    The total dose of morphine was calculated as mg and administered by PCA pump

Secondary outcomes

  1. Postoperative pain

    Time frame: Every 8 hrs

    NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)

  2. Side- effects

    Time frame: Every 8 hrs

    To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, shoulder pain, urinary retention, etc

  3. Hospital stay

    Time frame: Patients will be followed for the duration of hospital stay

  4. Patient satisfaction

    Time frame: 2 weeks after the operation

  5. Chronic Pain

    Time frame: 12 months after the operation

  6. Quality of life

    Time frame: 6 months after the operation

    SF 36 questionnaire

  7. Complications

    Time frame: 1 year

    seroma, hematoma, infection, recurrence of hernia, etc

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Collaborators

  • University of Thessaly

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2012
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.