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
1 other identifier
interventional
140
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Oct 2011
Longer than P75 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 19, 2012
CompletedFirst Posted
Study publicly available on registry
January 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMarch 16, 2017
March 1, 2017
3.6 years
January 19, 2012
March 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative opioid consumption
The total dose of morphine was calculated as mg and administered by PCA pump
Every 8 hours
Secondary Outcomes (7)
Postoperative pain
Every 8 hrs
Side- effects
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
- +2 more secondary outcomes
Study Arms (2)
Spinal anesthesia
ACTIVE COMPARATORTransabdominal Preperitoneal repair of inguinal hernia. spinal anesthesia
General Anesthesia
ACTIVE COMPARATORTransabdominal Preperitoneal repair of inguinal hernia. general anesthesia
Interventions
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia
Eligibility Criteria
You may qualify if:
- ASA physical status I-III
- BMI ≤ 35
- Age ≥ 18
- Normal coagulation profile
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Larissa University Hospitallead
- University of Thessalycollaborator
Study Sites (1)
University Hospital of Larissa
Larissa, 41100, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
- STUDY DIRECTOR
Stavroula Georgopoulou, MD
University Hospital of Larissa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN,MSc
Study Record Dates
First Submitted
January 19, 2012
First Posted
January 30, 2012
Study Start
October 1, 2011
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
March 16, 2017
Record last verified: 2017-03