NCT02033603

Brief Summary

Total knee arthroplasty or replacement (TKA) is a surgery performed for osteoarthritis of the knee which is increasingly performed as the population ages. It is a painful surgery and one of the methods to reduce post-operative pain is performing a regional anaesthesia technique. The current practice is to perform a femoral nerve block (FNB) which blocks the nerves supplying the knee joint and the thigh muscles (quadriceps). This provides effective analgesia. However, it also results in weakness of the quadriceps and may result in falls post-operatively. Adductor canal block (ACB) is a new, alternative regional anaesthesia technique which is hypothesised to provide as effective analgesia, with less quadriceps weakness compared to FNB, hence potentially reducing the risk of falls post-operatively. Investigators aim to study if the analgesia provided by ACB is as good as FNB while preserving quadriceps strength.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 1, 2015

Status Verified

January 1, 2014

Enrollment Period

8 months

First QC Date

January 9, 2014

Last Update Submit

December 31, 2014

Conditions

Keywords

Total knee arthroplastyTotal knee replacementFemoral Nerve BlockAdductor Canal Block

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    first 24 hours

Secondary Outcomes (4)

  • Pain scores

    1, 6, 12, 24, 48

  • Morphine consumption

    48 hours

  • Side effects of opioids- sedation, nausea and vomiting

    48 hours

  • Quadriceps strength, ability to mobilise

    24, 48 hours

Study Arms (2)

Femoral Nerve Block

ACTIVE COMPARATOR

Femoral Nerve block performed with 0.5% Ropivacaine 30mls (150mg)

Drug: Ropivacaine

Adductor Canal block

ACTIVE COMPARATOR

Adductor Canal block performed with 0.5% Ropivacaine 30mls (150mg)

Drug: Ropivacaine

Interventions

30mls of 0.5% ropivacaine

Also known as: naropin
Adductor Canal blockFemoral Nerve Block

Eligibility Criteria

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

You may qualify if:

  • ages 45-85
  • American Society of Anaesthesiologists physical status 1-3
  • BMI 18-35 kg/m2

You may not qualify if:

  • inability to give consent, communicate, cooperate
  • Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
  • Patients with 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
  • Patients who are unsuitable for general anaesthetics (eg difficult airway)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Yean Chin Lim, MBBS, MMed

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CTRU CGH

CONTACT

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

January 9, 2014

First Posted

January 13, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

January 1, 2015

Record last verified: 2014-01

Locations