Postoperative Patient Controlled Epidural Analgesia After Total Knee Arthroplasty With 2ug/ml Fentanyl Combine With 0.2% Ropivacaine or 0.2% Levobupivcaine
Primary Purpose
Arthroplasty, Replacement, Knee, Patient-controlled Analgesia
Status
Unknown status
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Levobupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Arthroplasty, Replacement, Knee focused on measuring post total knee replacement, patient control, epidural analgesia
Eligibility 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
Sites / Locations
- United Christian HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Levobupivacaine
Ropivacaine
Arm Description
patient control epidural analgeisa using 0.2% levobupivacaine with 2ug/ml fentanyl
patient controlled epidural analgesia using 0.2% ropivacaine with 2ug/ml fentanyl
Outcomes
Primary Outcome Measures
Pain score
as well as complications from epidural analgesia are also going to record and monitored
Secondary Outcome Measures
cost/treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01158586
Brief Title
Postoperative Patient Controlled Epidural Analgesia After Total Knee Arthroplasty With 2ug/ml Fentanyl Combine With 0.2% Ropivacaine or 0.2% Levobupivcaine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
United Christian Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee, Patient-controlled Analgesia
Keywords
post total knee replacement, patient control, epidural analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Levobupivacaine
Arm Type
Experimental
Arm Description
patient control epidural analgeisa using 0.2% levobupivacaine with 2ug/ml fentanyl
Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
patient controlled epidural analgesia using 0.2% ropivacaine with 2ug/ml fentanyl
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Intervention Description
patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl
Primary Outcome Measure Information:
Title
Pain score
Description
as well as complications from epidural analgesia are also going to record and monitored
Time Frame
48hours after start epidural analgesia
Secondary Outcome Measure Information:
Title
cost/treatment
Time Frame
48hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Njo, MBBS; FHKCA; FANZCA
Phone
852-35136175
Email
njokhnjo@yahoo.com.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Brake
Facility Information:
Facility Name
United Christian Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
Citation
Reference 1. Block et al. Efficiancy of postoperative epidural analgesia: A meta-analysis. JAMA 290: 2455-63 2. Werawatganon T. Patient controlled intravenous opioid analgesia versus continuous epidural analgesia for pain after intra-abdominal surgery. The Cochrane Databas of systemic reviews. Issue 3 Art. No.: No.: CD 004044. DOI: 10.1002/14651858. CD004088.pub2. 3. Liu SS et al. Patient-controlled epidural analgesia with bupivacaine and fentanyl on hospital wards: propective experience with 1,030 surgical patients Anesthesiology 88: 388-95 4. Silvasti M et al. Patient-controlled analgesia versus continuous epidural analgesia after total knee arthroplasty Acta Anaesthesiol Scand 42: 576 - 80 5. Stand T et al. Patient-controlled epidural analgesia reduces analgesic requirements compared to continuous epidural infusion after major abdominal surgery. Can J Anaesth 50:258-64 6. Linda S. et al. Relative Analgesic Potencies of Levobupivacaine and Ropivacaine for Epidural Analgesia in Labor. Anesthesiology 2003; 99:1354-8 7. Marc Senard et al. Epidural Levobupivacaine 0.1% or Ropivacaine 0.1% Combined with Morphine Provides Comparable Analgesia After Abdominal Surgery Anesth Analg 2004;98:389-94 8. Kelly AM The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain.Emerg Med J 2001; 18:205-07 9. Mark MSM et al. The minimum clinically significant difference in visual analogue scale pain score in a local emergency setting. Hong Kong Journal of Emergency Medicine 2009; 16(4): 234-6 10. Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov; 5(11): 1086-90.
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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
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