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Postoperative Patient Controlled Epidural Analgesia After Total Knee Arthroplasty With 2ug/ml Fentanyl Combine With 0.2% Ropivacaine or 0.2% Levobupivcaine

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01158586
Enrollment
60
Registered
2010-07-08
Start date
2010-04-30
Completion date
2010-12-31
Last updated
2010-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee, Patient-controlled Analgesia

Keywords

post total knee replacement, patient control, epidural analgesia

Brief summary

Postoperative epidural analgesia (EA) is an effective and well-accepted modality of pain relief technique after having total knee replacement operation(1,4). Patient controlled epidural analgesia (PCEA) has been shown to be safe and effective in standard ward setting(2) and results in reduced epidural analgesic requirements(3). Besides, it also bear the advantage of avoidance of overdose, reduction of waiting times and involvement of patients in their analgesic regimen(3). Both ropivacaine and levobupivacaine are the local anaesthetic using in epidural analgesia which has been proven to be safe and effective(4). 0.2% Ropivacaine with 2ug/ml fentanyl has been used in our locality for more than 8 years. Another local anaesthetics, levobupivacaine, a S-enantiomer of bupivacaine has come up in Hong Kong, which has been proved to be safe, effective and may be better value for money. These two drugs has been proven to have similar analgesic potency in using as EA for postoperative pain relief for other operation(5,6,7) and for orthropaedics operation but in different concentration(4). Concerns have been raised about the introduction of the levobupivacaine in the departmental protocol. Objectives of this study are A)to determine the equivalence of two local anaesthetics regimen ; 0.2% ropivacaine with 2ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl and B) to assess the cost-effectiveness of using these two regimens. The null hypothesis is that the difference of analgesic effect, presented with visual analogue score, of two patient controlled epidural analgesia regimen, the 0.2% ropivacaine with 2 ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl is higher than the threshold of 9 mm VAS. (8,9,10)

Interventions

DRUGLevobupivacaine

patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl

Sponsors

United Christian Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \> 18 years old, ASA I -III and * Undergoing total knee arthroplasty * Combine spinal-epidural anaesthesia

Exclusion criteria

* Known hypersensitivity to amide-type local anaesthetics * Known hypersensitivity to opioids * Known history of severe cardiovascular, renal, hepatic, neurological or psychiatric disease as judged by the investigator * Known history of peripheral neuropathies * Those receiving chronic analgesic therapy, or any contraindication for epidural analgesia (e.g. clotting disorders, or history of lumbar surgery) * Inability to perform a pain score, or pregnancy or lactation

Design outcomes

Primary

MeasureTime frameDescription
Pain score48hours after start epidural analgesiaas well as complications from epidural analgesia are also going to record and monitored

Secondary

MeasureTime frame
cost/treatment48hours

Countries

Hong Kong

Contacts

Primary ContactAnthony Njo, MBBS; FHKCA; FANZCA
njokhnjo@yahoo.com.hk852-35136175
Backup ContactTimothy Brake

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026