Peripheral Nerve Block (Femoral - Sciatic - Obturator) Versus General Anesthesia for Arthroscopic ACL Repair

Surgery Clinical Trial

Official title:

Comparison of Femoral - Sciatic - Obturator Nerve Block vs General Anesthesia in Combination With Continuous or Bolus Femoral Nerve Block for Arthroscopic ACL Repair Regarding the Time of Patient Mobilasation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02186899
• Other study ID #: FSOvsGA
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2014
• Last updated: July 7, 2014
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2014
• Source: Larissa University Hospital
• Contact: Marina Simaioforidou, Medicine
• Phone: 00306947845083
• Email: msimaiof[@]otenet.gr
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few years peripheral nerve blocks have increased their popularity for this kind of operation. The investigators want to see how the type of anesthesia and postoperative analgesia effects the time required for patient mobilisation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18 - 80 yrs

• ASA I - III

• ACL surgery

Exclusion Criteria:

• Coagulopathy disorders

• Infection at the puncture site for the interscalene block

• Neurologic deficit in the arm that is going to be operated

• Allergy to local anesthetics

• BMI > 35

• Psychiatric disorders

• Patient's refusal

• Problems with patient communication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anesthesia Care
• Arthroscopic ACL Rerpair
• Surgery

Intervention

Other:
• Ultrasound Guided Femoral Sciatic Obturator nerve blocks

• General Anesthesia femoral bolus

• General anesthesia femoral continuous

Locations

Country	Name	City	State
Greece	Private Clinic of Larissa "Asklipeiio"	Larissa

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chronic pain development	Use of questionnaire for the functional state of the knee and VAS score for the pain	24 weeks postoperatively	No
Primary	Surgery completed without pain for the patient	Use of VAS score	Completion of the surgery	No
Primary	Postoperative pain	Use of VAS score	1st postoperative day	No
Secondary	Mobilization of the knee	How many degrees can the patient bend the knee	24 weeks postoperatively	No