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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Larissa University Hospital
Sponsor:
Collaborator:
University of Thessaly
Information provided by (Responsible Party):
Chamaidi Sarakatsianou, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01520857
First received: January 19, 2012
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention
Postoperative Pain
Procedure: Transabdominal Preperitoneal (TAPP) repair of inguinal hernia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia

Resource links provided by NLM:


Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • Postoperative opioid consumption [ Time Frame: Every 8 hours ] [ Designated as safety issue: No ]
    The total dose of morphine was calculated as mg and administered by PCA pump


Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: Every 8 hrs ] [ Designated as safety issue: No ]
    NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)

  • Side- effects [ Time Frame: Every 8 hrs ] [ Designated as safety issue: Yes ]
    To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, shoulder pain, urinary retention, etc

  • Hospital stay [ Time Frame: Patients will be followed for the duration of hospital stay ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 2 weeks after the operation ] [ Designated as safety issue: No ]
  • Chronic Pain [ Time Frame: 12 months after the operation ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 months after the operation ] [ Designated as safety issue: No ]
    SF 36 questionnaire

  • Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    seroma, hematoma, infection, recurrence of hernia, etc


Estimated Enrollment: 140
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Spinal anesthesia
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia under spinal anesthesia
Procedure: Transabdominal Preperitoneal (TAPP) repair of inguinal hernia
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia
Active Comparator: General Anesthesia
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia under general anesthesia
Procedure: Transabdominal Preperitoneal (TAPP) repair of inguinal hernia
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under general anesthesia

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520857

Contacts
Contact: Chamaidi Sarakatsianou, RN, MSc +302413501351 heidisarak@gmail.com
Contact: George Tzovaras, MD +302413502730 gtzovaras@hotmail.com

Locations
Greece
University Hospital of Larissa Recruiting
Larissa, Greece, 41100
Contact: Chamaidi Sarakatsianou, RN,MSc    +302413501351    heidisarak@gmail.com   
Contact: George Tzovaras, MD    +302413502730    gtzovaras@hotmail.com   
Principal Investigator: Chamaidi Sarakatsianou, RN,MSc         
Sub-Investigator: Stavroula Georgopoulou, MD         
Sub-Investigator: Elena Theodorou, MD         
Sponsors and Collaborators
Larissa University Hospital
University of Thessaly
Investigators
Principal Investigator: Chamaidi Sarakatsianou, RN,MSc University Hospital of Larissa
Study Chair: George Tzovaras, MD University Hospital of Larissa
Study Director: George Tzovaras, MD University Hospital of Larissa
  More Information

No publications provided

Responsible Party: Chamaidi Sarakatsianou, RN,MSc, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01520857     History of Changes
Other Study ID Numbers: UTH5535/12/11
Study First Received: January 19, 2012
Last Updated: September 2, 2013
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Larissa University Hospital:
Laparoscopic inguinal hernia repair
TAPP
Spinal Anesthesia
General Anesthesia

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pain, Postoperative
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014