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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520857
• Other study ID #: UTH5535/12/11
• Status: Completed
• Phase: N/A
• First received: January 19, 2012
• Last updated: March 15, 2017
• Start date: October 2011
• Est. completion date: May 2015

Study information

• Verified date: March 2017
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Transabdominal Preperitoneal repair of inguinal hernia
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia
• Transabdominal Preperitoneal repair of inguinal hernia
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under general anesthesia

Locations

Country	Name	City	State
Greece	University Hospital of Larissa	Larissa

Sponsors (2)

Lead Sponsor	Collaborator
Larissa University Hospital	University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	The total dose of morphine was calculated as mg and administered by PCA pump	Every 8 hours
Secondary	Postoperative pain	NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)	Every 8 hrs
Secondary	Side- effects	To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, shoulder pain, urinary retention, etc	Every 8 hrs
Secondary	Hospital stay		Patients will be followed for the duration of hospital stay
Secondary	Patient satisfaction		2 weeks after the operation
Secondary	Chronic Pain		12 months after the operation
Secondary	Quality of life	SF 36 questionnaire	6 months after the operation
Secondary	Complications	seroma, hematoma, infection, recurrence of hernia, etc	1 year