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Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction Arthroscopically

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ClinicalTrials.gov Identifier: NCT02355093
Recruitment Status : Unknown
Verified January 2015 by Daqiang Zhao, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : February 4, 2015
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Daqiang Zhao, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia; Reaction Procedure: adductor canal block (ACB) Procedure: Femoral nerve block (FNB) Drug: ropivacaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction Arthroscopically
Study Start Date : July 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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.
Procedure: 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.

Drug: ropivacaine
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.
Procedure: 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.

Drug: ropivacaine



Primary Outcome Measures :
  1. quadriceps muscle strength, as measured by handheld dynamometer. [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. pain at rest time and during flexion of the knee, as measured by visual analog score(VAS). [ Time Frame: 3 days ]

Other Outcome Measures:
  1. Dose of opioids [ Time Frame: 3 days ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355093


Sponsors and Collaborators
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Investigators
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Principal Investigator: Daqiang Zhao, Master Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China

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Responsible Party: Daqiang Zhao, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
ClinicalTrials.gov Identifier: NCT02355093    
Other Study ID Numbers: ACB vs FNB
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents