Peripheral Nerve Block (Femoral - Sciatic - Obturator) Versus General Anesthesia for Arthroscopic ACL Repair
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
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 27, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 10, 2014
July 1, 2014
1.5 years
April 27, 2014
July 7, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Surgery completed without pain for the patient
Use of VAS score
Completion of the surgery
Postoperative pain
Use of VAS score
1st postoperative day
Secondary Outcomes (1)
Mobilization of the knee
24 weeks postoperatively
Other Outcomes (1)
Chronic pain development
24 weeks postoperatively
Study Arms (3)
General Anesthesia Femoral continuous
ACTIVE COMPARATORGeneral anesthesia plus continuous femoral nerve block
General anesthesia Femoral bolus
ACTIVE COMPARATORGeneral anesthesia plus single shot femoral nerve block
Femoral Sciatic Obturator Nerve block
ACTIVE COMPARATORUltrasound guided femoral plus sciatic plus obturator nerve block
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 - 80 yrs
- ASA I - III
- ACL surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Private Clinic of Larissa "Asklipeiio"
Larissa, Larissa, Greece
Study Officials
- STUDY DIRECTOR
Marina Simaioforidou, Medicine
Private Clinic of Larissa "Asklipeiio"
- STUDY CHAIR
George Basdekis, Medicine
Private Clinic of Larissa "Asklipeiio"
- STUDY CHAIR
Konstantinos Bargiotas, Medicine
Larissa University Hospital
- STUDY CHAIR
Aristeidis Zibis, Medicine
Private Clinic of Larissa "Askipeiio"
- STUDY CHAIR
Athanasios Drakos, Medicine
Larissa University Hospital
- PRINCIPAL INVESTIGATOR
Metaxia Bareka, Medicine
Larissa University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
April 27, 2014
First Posted
July 10, 2014
Study Start
March 1, 2014
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
July 10, 2014
Record last verified: 2014-07