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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by United Christian Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
United Christian Hospital
ClinicalTrials.gov Identifier:
NCT01158586
First received: July 7, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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)


Condition Intervention Phase
Arthroplasty, Replacement, Knee
Patient-controlled Analgesia
Drug: Levobupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by United Christian Hospital:

Primary Outcome Measures:
  • Pain score [ Time Frame: 48hours after start epidural analgesia ] [ Designated as safety issue: Yes ]
    as well as complications from epidural analgesia are also going to record and monitored


Secondary Outcome Measures:
  • cost/treatment [ Time Frame: 48hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levobupivacaine
patient control epidural analgeisa using 0.2% levobupivacaine with 2ug/ml fentanyl
Drug: Levobupivacaine
patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl
Active Comparator: Ropivacaine
patient controlled epidural analgesia using 0.2% ropivacaine with 2ug/ml fentanyl
Drug: Levobupivacaine
patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158586

Contacts
Contact: Anthony Njo, MBBS; FHKCA; FANZCA 852-35136175 njokhnjo@yahoo.com.hk
Contact: Timothy Brake

Locations
Hong Kong
United Christian Hospital Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
United Christian Hospital
  More Information

No publications provided

Responsible Party: Dr. Anthony Kui Hung Njo, Hospital Authority
ClinicalTrials.gov Identifier: NCT01158586     History of Changes
Other Study ID Numbers: PCEA-LEVO-ROPI
Study First Received: July 7, 2010
Last Updated: July 7, 2010
Health Authority: Hong Kong: Department of Health

Keywords provided by United Christian Hospital:
post total knee replacement
patient control
epidural analgesia

Additional relevant MeSH terms:
Bupivacaine
Fentanyl
Levobupivacaine
Ropivacaine
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014