Clinical trial NCT01520857: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Laparoscopic inguinal hernia repair
TAPP
Spinal Anesthesia
General Anesthesia
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
Collaborators: name: University of Thessaly
First posted: 2012-01-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: Every 8 hours
Secondary outcomes:
measure: Postoperative pain
timeFrame: Every 8 hrs
measure: Side- effects
timeFrame: Every 8 hrs
measure: Hospital stay
timeFrame: Patients will be followed for the duration of hospital stay
measure: Patient satisfaction
timeFrame: 2 weeks after the operation
measure: Chronic Pain
timeFrame: 12 months after the operation
measure: Quality of life
timeFrame: 6 months after the operation
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
Study officials:
affiliation: University Hospital of Larissa
name: Chamaidi Sarakatsianou, RN,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Larissa
name: George Tzovaras, MD
role: STUDY_CHAIR
affiliation: University Hospital of Larissa
name: George Tzovaras, MD
role: STUDY_DIRECTOR
affiliation: University Hospital of Larissa
name: Stavroula Georgopoulou, MD
role: STUDY_DIRECTOR
References: