- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02355093
Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction Arthroscopically
January 30, 2015 updated by: Daqiang Zhao, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
This study aims to compare continuous femoral nerve block with adductor canal block after anterior cruciate ligament reconstruction arthroscopically,especially in the effect on quadriceps strength; and to evaluate which regional anesthesia is more ideal for the patients postoperatively.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Forty patients with American Society of Anesthesiologists(ASA) Ⅰ-Ⅲ(no limitation of age and gender)are randomized to receive either a continuous adductor canal block(ACB) or a femoral nerve block(FNB) via a catheter (a continuous infusion of 0.2% ropivacaine, 5 mL/h for 48 hours)in the PACU immediately after the anterior cruciate ligament reconstruction arthroscopically.
Patients were under general anesthesia during the operation and received a femoral nerve block with 0.25% ropivacaine 10ml before the surgery.Both groups will receive postoperatively IV patient controlled analgesia (PCA) with morphine (bolus 0.8mg,lock-out time 15 minutes, background infusion 2ml/h)beside the continuous nerve block.
Patients are going to be visited for follow-up on the day of surgery and in the following two days.
Quadriceps strength is assessed with the displacement of patella.VAS at rest time、degree of knee flexion、VAS at 45°flexion of the knee、dose of opioids、whether the patient has sleep disturbance are also recorded.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA Ⅰ-Ⅲ
- Anterior Cruciate Ligament Reconstruction
Exclusion Criteria:
- patient refusal
- chronic use of opioids
- coagulation disorders
- infection at the puncture site
- allergic to anaesthetic
- preexisting neurological disorders
- communication difficulties
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: adductor canal block (ACB)
We performed an ultrasound survey at the medial part of the thigh,the needle is introduced in-plane and 2 to 3 mL of saline is used to ensure correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal,the catheter is introduced and advanced 1 to 2 cm beyond the tip of the needle.The study medication is administered as an infusion of 0.2% ropivacaine at a rate of 5mL/h during the next 48 hours.
|
We performed an ultrasound survey at the medial part of the thigh,the needle is introduced in-plane and 2 to 3 mL of saline is used to ensure correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal,the catheter is introduced and advanced 1 to 2 cm beyond the tip of the needle.The study medication is administered as an infusion of 0.2% ropivacaine at a rate of 5mL/h during the next 48 hours.
|
Active Comparator: Femoral nerve block (FNB)
the catheter is inserted in-plane with the probe parallel to the inguinal crease, to obtain a short-axis view of the nerve.
The correct needle placement is confirmed by injecting 2 to 3 mL of saline to cause tissue expansion below the iliac fascia, lateral to the femoral artery, and in the vicinity of the femoral nerve.
The catheter is introduced 1 to 2 cm beyond the tip of the needle,an infusion of 0.2% ropivacaine at a rate of 5mL/h is administered during the next 48 hours.
|
the catheter is inserted in-plane with the probe parallel to the inguinal crease, to obtain a short-axis view of the nerve.
The correct needle placement is confirmed by injecting 2 to 3 mL of saline to cause tissue expansion below the iliac fascia, lateral to the femoral artery, and in the vicinity of the femoral nerve.
The catheter is introduced 1 to 2 cm beyond the tip of the needle,an infusion of 0.2% ropivacaine at a rate of 5mL/h is administered during the next 48 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quadriceps muscle strength, as measured by handheld dynamometer.
Time Frame: 3 days
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain at rest time and during flexion of the knee, as measured by visual analog score(VAS).
Time Frame: 3 days
|
3 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose of opioids
Time Frame: 3 days
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daqiang Zhao, Master, Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Anticipated)
March 1, 2015
Study Completion (Anticipated)
October 1, 2015
Study Registration Dates
First Submitted
January 28, 2015
First Submitted That Met QC Criteria
January 30, 2015
First Posted (Estimate)
February 4, 2015
Study Record Updates
Last Update Posted (Estimate)
February 4, 2015
Last Update Submitted That Met QC Criteria
January 30, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACB vs FNB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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