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

Anesthesia; Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02355093
• Other study ID #: ACB vs FNB
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: January 28, 2015
• Last updated: January 30, 2015
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2015
• Source: Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ASA ?-?

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia; Reaction

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dose of opioids		3 days	Yes
Primary	quadriceps muscle strength, as measured by handheld dynamometer.		3 days	Yes
Secondary	pain at rest time and during flexion of the knee, as measured by visual analog score(VAS).		3 days	Yes