Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Transabdominal Preperitoneal repair of inguinal hernia
Transabdominal Preperitoneal repair of inguinal hernia
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Laparoscopic inguinal hernia repair, TAPP, Spinal Anesthesia, General Anesthesia
Eligibility 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
Sites / Locations
- University Hospital of Larissa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Spinal anesthesia
General Anesthesia
Arm Description
Transabdominal Preperitoneal repair of inguinal hernia. spinal anesthesia
Transabdominal Preperitoneal repair of inguinal hernia. general anesthesia
Outcomes
Primary Outcome Measures
Postoperative opioid consumption
The total dose of morphine was calculated as mg and administered by PCA pump
Secondary Outcome Measures
Postoperative pain
NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)
Side- effects
To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, shoulder pain, urinary retention, etc
Hospital stay
Patient satisfaction
Chronic Pain
Quality of life
SF 36 questionnaire
Complications
seroma, hematoma, infection, recurrence of hernia, etc
Full Information
NCT ID
NCT01520857
First Posted
January 19, 2012
Last Updated
March 15, 2017
Sponsor
Larissa University Hospital
Collaborators
University of Thessaly
1. Study Identification
Unique Protocol Identification Number
NCT01520857
Brief Title
Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia
Official Title
A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Larissa University Hospital
Collaborators
University of Thessaly
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Laparoscopic inguinal hernia repair, TAPP, Spinal Anesthesia, General Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal anesthesia
Arm Type
Active Comparator
Arm Description
Transabdominal Preperitoneal repair of inguinal hernia. spinal anesthesia
Arm Title
General Anesthesia
Arm Type
Active Comparator
Arm Description
Transabdominal Preperitoneal repair of inguinal hernia. general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Transabdominal Preperitoneal repair of inguinal hernia
Intervention Description
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia
Intervention Type
Procedure
Intervention Name(s)
Transabdominal Preperitoneal repair of inguinal hernia
Intervention Description
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under general anesthesia
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
The total dose of morphine was calculated as mg and administered by PCA pump
Time Frame
Every 8 hours
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)
Time Frame
Every 8 hrs
Title
Side- effects
Description
To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, shoulder pain, urinary retention, etc
Time Frame
Every 8 hrs
Title
Hospital stay
Time Frame
Patients will be followed for the duration of hospital stay
Title
Patient satisfaction
Time Frame
2 weeks after the operation
Title
Chronic Pain
Time Frame
12 months after the operation
Title
Quality of life
Description
SF 36 questionnaire
Time Frame
6 months after the operation
Title
Complications
Description
seroma, hematoma, infection, recurrence of hernia, etc
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chamaidi Sarakatsianou, RN,MSc
Organizational Affiliation
University Hospital of Larissa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Tzovaras, MD
Organizational Affiliation
University Hospital of Larissa
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
George Tzovaras, MD
Organizational Affiliation
University Hospital of Larissa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stavroula Georgopoulou, MD
Organizational Affiliation
University Hospital of Larissa
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41100
Country
Greece
12. IPD Sharing Statement
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Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia
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