NCT02104934

Brief Summary

Total knee arthroplasty or replacement (TKA), a commonly performed surgery for osteoarthritis of the knee, is a painful procedure and requires a multimodal analgesic approach. A method for analgesia is local infiltration analgesia (LIA), where a mixture of drugs is injected around the knee joint. Adductor canal block (ACB) is an alternative regional anaesthesia technique which has been shown to result in minimal thigh weakness. The investigators aim to study if the analgesia provided by ACB is superior to LIA while preserving quadriceps strength.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 25, 2017

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

March 18, 2014

Last Update Submit

April 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption in the first 24 hours

    morphine consumption in the first 24 hours (including morphine administered in recovery and via PCA).

    24 hours

Secondary Outcomes (5)

  • Pain Scores

    1, 6, 12, 24 hours; up to 48 hours postoperative

  • Morphine Consumption

    At 48 hours

  • Postoperative Nausea and Vomiting

    Up to 48 hours

  • Sedation Scores

    Up to 48 hours

  • Quadriceps Strength

    at 24 and 48 hours

Other Outcomes (2)

  • Presence of Complications

    up to 48 hours

  • Length of Hospital Stay

    Up to 30 days

Study Arms (2)

Local Infiltration Analgesia

NO INTERVENTION

The Local Infiltration Analgesia group will receive local infiltration of ropivacaine 150mg, ketorolac 30mg, morphine 10mg, adrenaline 200mcg and vancomycin 500mg in a total volume of 75mls by the surgeon.

Adductor Canal Block

ACTIVE COMPARATOR

The Adductor Canal Block group of patients will receive intravenous ketorolac 30mg intra-operatively and an adductor canal block at the end of surgery. The block will be performed under real time ultrasound guidance and 30mls of 0.5% ropivacaine (150mg) is injected with a Stimuplex A100, 21G needle.

Procedure: Adductor Canal Block

Interventions

Adductor Canal Block

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for primary TKA under single shot spinal anaesthesia, between ages 45-85 years old, American Society of Anesthesiologists (ASA) physical status 1 to 3 and BMI 18-35 kg/m2

You may not qualify if:

  • Patients unable to give consent, inability to communicate/ cooperate, patients with regular consumption of strong opioids (morphine, oxycodone) or steroids, allergy to local anaesthetics or any drugs included in the study, patients with lower limb surgery in the preceding year, patients with pre-existing neurological deficits and patients who have contraindications for spinal anaesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, Singapore

Location

Study Officials

  • Yean Chin Lim, MBBS

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 18, 2014

First Posted

April 7, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

April 25, 2017

Record last verified: 2015-07

Locations