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Clinical Trials/NCT01520857
NCT01520857
Completed
Not Applicable

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

Larissa University Hospital1 site in 1 country140 target enrollmentOctober 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Larissa University Hospital
Enrollment
140
Locations
1
Primary Endpoint
Postoperative opioid consumption
Status
Completed
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
May 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Larissa University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Chamaidi Sarakatsianou

RN,MSc

Larissa University Hospital

Eligibility Criteria

Inclusion Criteria

  • ASA physical status I-III
  • 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

Outcomes

Primary Outcomes

Postoperative opioid consumption

Time Frame: Every 8 hours

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

Secondary Outcomes

  • Quality of life(6 months after the operation)
  • Patient satisfaction(2 weeks after the operation)
  • Complications(1 year)
  • Postoperative pain(Every 8 hrs)
  • Side- effects(Every 8 hrs)
  • Hospital stay(Patients will be followed for the duration of hospital stay)
  • Chronic Pain(12 months after the operation)

Study Sites (1)

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