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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02033603
Other study ID # 2013/ 921/ D
Secondary ID
Status Recruiting
Phase N/A
First received January 9, 2014
Last updated December 31, 2014
Start date January 2014
Est. completion date December 2014

Study information

Verified date January 2014
Source Changi General Hospital
Contact CTRU CGH
Phone 67888833
Is FDA regulated No
Health authority Singapore: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 85 Years
Eligibility Inclusion Criteria:

- ages 45-85

- American Society of Anaesthesiologists physical status 1-3

- BMI 18-35 kg/m2

Exclusion Criteria:

- 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)

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Ropivacaine
30mls of 0.5% ropivacaine

Locations

Country Name City State
Singapore Changi General Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morphine consumption first 24 hours No
Secondary Pain scores 1, 6, 12, 24, 48 No
Secondary Morphine consumption 48 hours No
Secondary Side effects of opioids- sedation, nausea and vomiting 48 hours Yes
Secondary Quadriceps strength, ability to mobilise 24, 48 hours No
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