NCT01791036

Brief Summary

Adductor canal block will provide adequate analgesia to patients undergoing arthroscopic ACL reconstruction surgery, yet result in less motor blockade than a femoral block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 4, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

February 11, 2013

Last Update Submit

March 2, 2015

Conditions

Keywords

Adductor canal blockFemoral Nerve Block

Outcome Measures

Primary Outcomes (3)

  • Opioid consumption

    Postoperative cumulative opioid consumption during the first 24 hours. All doses of supplemental (PRN) oral and parenteral opioid analgesics required will be converted into equivalent doses of oral morphine

    24 hours

  • Motor Blockade

    The degree of motor blockade 30 minutes following the block procedure

    30 minutes

  • Pain Scores

    Visual Analog Pain scores at rest and with movement at admisssion and discharge from post-anesthesia care unit (PACU), AT DISCHARGE FROM same day surgery unit (SDC) and at 12, 24 and 48 hours

    12,24 and 48 hours

Secondary Outcomes (2)

  • Sensory blockade

    30 min

  • Spread of local anesthetic

    30 min

Other Outcomes (2)

  • Block procedure time

    min

  • Block success

    30 min

Study Arms (2)

Adductor Canal Block Group

EXPERIMENTAL

Adductor Canal Block

Procedure: Adductor Canal Block

Femoral Nerve Block Group

ACTIVE COMPARATOR

Femoral Nerve Block

Procedure: Femoral Nerve Block

Interventions

Examination of the adductor canal using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin in the medial upper-thigh region. The ultrasound probe will be moved either cephalad or caudad from its initial position in order to visualize the femoral artery immediately deep to the middle of the sartorius muscle. This point will then be selected as the appropriate level for needle insertion. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding.

Adductor Canal Block Group

Examination of the femoral nerve using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin at the level of the femoral crease. The femoral artery will be identified and the femoral nerve will then be located immediately lateral to the artery, deep to the fascia iliaca and superficial to the iliopsoas muscle. The needle will be positioned next to the femoral nerve. Following this 20 ml of 0.25% bupivacaine with epinephrine will be injected incrementally over a 1 to 2 minute period. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding.

Femoral Nerve Block Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists(ASA)classification I-III, Patients 18 to 50 years of age, BMI 18 - 40. Patients scheduled for anterior cruciate ligament reconstruction surgery under general anesthesia and nerve blocks.

You may not qualify if:

  • Refusal or inability to provide informed consent. Any contraindication to regional anesthesia including coagulopathy or bleeding diathesis, allergy to local anesthetics, infection, nerve injury or malignancy at the site of the block.
  • History of alcohol/drug dependence. History of long term opioid intake or chronic pain disorder. History of preexisting neuropathy in the operative leg History of significant psychiatric conditions that may affect patient assessment.
  • Inability to understand the informed consent and demands of the study. Allergy to any of the components of the multimodal analgesic regimen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (3)

  • Williams BA, Kentor ML, Vogt MT, Irrgang JJ, Bottegal MT, West RV, Harner CD, Fu FH, Williams JP. Reduction of verbal pain scores after anterior cruciate ligament reconstruction with 2-day continuous femoral nerve block: a randomized clinical trial. Anesthesiology. 2006 Feb;104(2):315-27. doi: 10.1097/00000542-200602000-00018.

    PMID: 16436852BACKGROUND
  • Dauri M, Fabbi E, Mariani P, Faria S, Carpenedo R, Sidiropoulou T, Coniglione F, Silvi MB, Sabato AF. Continuous femoral nerve block provides superior analgesia compared with continuous intra-articular and wound infusion after anterior cruciate ligament reconstruction. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):95-9. doi: 10.1097/AAP.0b013e31819baf98.

    PMID: 19282706BACKGROUND
  • Sakura S, Hara K, Ota J, Tadenuma S. Ultrasound-guided peripheral nerve blocks for anterior cruciate ligament reconstruction: effect of obturator nerve block during and after surgery. J Anesth. 2010 Jun;24(3):411-7. doi: 10.1007/s00540-010-0916-3. Epub 2010 Mar 12.

    PMID: 20225073BACKGROUND

Study Officials

  • Vincent Chan, MD

    University of Toronto

    PRINCIPAL INVESTIGATOR
  • Richard Brull, MD

    UHN - Women's College Hospital and Toronto Western Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 13, 2013

Study Start

May 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 4, 2015

Record last verified: 2015-03

Locations