Arthroplasty, Replacement, KneePhase 4NCT01158586
Postoperative Patient Controlled Epidural Analgesia After Total Knee Arthroplasty With 2ug/ml Fentanyl Combine With 0.2% Ropivacaine or 0.2% Levobupivcaine
A Phase 4 study testing Levobupivacaine in people with Arthroplasty, Replacement, Knee and Patient-controlled Analgesia, run by United Christian Hospital at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Patient-controlled Analgesia
- What is being tested?
- Levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old, ASA I -III and
- Undergoing total knee arthroplasty
- Combine spinal-epidural anaesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Timothy Brake contact
About this study
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)
- Being tested
- Levobupivacaine
- Keywords
- post total knee replacement, patient control, epidural analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine | Experimental | patient control epidural analgeisa using 0.2% levobupivacaine with 2ug/ml fentanyl Receives: Drug: Levobupivacaine |
| Ropivacaine | Active comparator | patient controlled epidural analgesia using 0.2% ropivacaine with 2ug/ml fentanyl Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
as well as complications from epidural analgesia are also going to record and monitored
Measured: 48hours after start epidural analgesia
Secondary outcomes (1)
cost/treatment
Measured: 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Christian Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158586
- Sponsor's protocol ID
- PCEA-LEVO-ROPI
- Status last verified
- Feb 2010
- First submitted
- 7 Jul 2010
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Patient Controlled Epidural Analgesia After Total Knee Arthroplasty With 2ug/ml Fentanyl Combine With 0.2% Ropivacaine or 0.2% Levobupivcaine
- ClinicalTrials.gov ID
- NCT01158586
- Acronym / sponsor ID
- PCEA-LEVO-ROPI
- Keywords
- post total knee replacement, patient control, epidural analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- United Christian HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine | Experimental | Drug: Levobupivacainepatient control epidural analgeisa using 0.2% levobupivacaine with 2ug/ml fentanyl |
| Ropivacaine | Active comparator | Drug: Levobupivacainepatient controlled epidural analgesia using 0.2% ropivacaine with 2ug/ml fentanyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years old, ASA I -III and
- Undergoing total knee arthroplasty
- Combine spinal-epidural anaesthesia
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levobupivacainepatient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl | Drug | Levobupivacaine, Ropivacaine |
Primary outcome
Pain score
Time frame: 48hours after start epidural analgesia
as well as complications from epidural analgesia are also going to record and monitored
1 secondary outcome
cost/treatment
Time frame: 48hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2010.
- BackgroundReference 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Brake contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine in people with Arthroplasty, Replacement, Knee and Patient-controlled Analgesia, run by United Christian Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Njo, MBBS; FHKCA; FANZCA (852-35136175, njokhnjo@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 48hours after start epidural analgesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2010; AzTrials last refreshed its copy on 7 Nov 2026.