NCT02355093

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2014

Status
unknown

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

July 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 4, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

January 28, 2015

Last Update Submit

January 30, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • quadriceps muscle strength, as measured by handheld dynamometer.

    3 days

Secondary Outcomes (1)

  • pain at rest time and during flexion of the knee, as measured by visual analog score(VAS).

    3 days

Other Outcomes (1)

  • Dose of opioids

    3 days

Study Arms (2)

adductor canal block (ACB)

EXPERIMENTAL

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)Drug: ropivacaine

Femoral nerve block (FNB)

ACTIVE COMPARATOR

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)Drug: ropivacaine

Interventions

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.

adductor canal block (ACB)

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.

Femoral nerve block (FNB)
Femoral nerve block (FNB)adductor canal block (ACB)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASA Ⅰ-Ⅲ
  • Anterior Cruciate Ligament Reconstruction

You may not qualify if:

  • patient refusal
  • chronic use of opioids
  • coagulation disorders
  • infection at the puncture site
  • allergic to anaesthetic
  • preexisting neurological disorders
  • communication difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Daqiang Zhao, Master

    Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Daqiang Zhao

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 4, 2015

Study Start

July 1, 2014

Primary Completion

March 1, 2015

Study Completion

October 1, 2015

Last Updated

February 4, 2015

Record last verified: 2015-01