Pain, PostoperativePhase 4NCT00270322
Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
A Phase 4 study testing Marcaine 0.166% + Fentanyl 3.33 mcg/ml and Morphine sulphate in people with Pain, Postoperative and Osteoarthritis, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Pain, Postoperative, Osteoarthritis
- What is being tested?
- Marcaine 0.166% + Fentanyl 3.33 mcg/ml and Morphine sulphate
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2006to Mar 2007
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Age: 55 to 85 years
- Osteoarthritis
- Primary unilateral total knee replacement
- American Society of Anesthesiologists (ASA) I-III
- Successful spinal epidural anesthesia for surgery
Who cannot join
- Any cause for knee replacement other than osteoarthritis
- Total knee revision (re-do)
- Any contraindication for regional anesthesia
- Abnormal coagulation studies
- Thrombocytopenia less than 100,000/cc
- Chronic renal failure (creatinine [cr] < 1.8)
Show all 12Show fewer
- Neurological disease involving lower extremities
- Major surgery during the last 2 weeks pre-operatively
- Current or past drug or alcohol abuse
- Allergy to study medications
- Post-operative bleeding over 2000 cc/24 hours
- Postdural puncture headache after anesthesia performance
Trial locations and contacts
1 site in 1 country.
About this study
The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.
Read the detailed description
Total knee replacement (TKR) is known to be one of the most painful surgical procedures. Many treatments have been used post TKR: IV opioids, epidural infusions, peripheral nerve blocks. No one method has been recognised as the best one.
In this study we will compare two well established methods of pain treatment:
- continuous infusion of local anesthetics + opioids into the epidural space,
- patient controlled analgesia with IV Morphine.
The study design is double blind.
Patients will have a combined spinal-epidural anesthesia for the operation and then will be connected to 2 different pumps, one to the epidural catheter and one to the intravenous catheter, for the first 24 hours post-operatively.
Pain scores, total analgesic medications other than study medications, adverse reactions to study medications, complications and patient satisfaction will be followed by blinded observers and compared between groups.
- Conditions
- Pain, Postoperative, Osteoarthritis
- Being tested
- Marcaine 0.166% + Fentanyl 3.33 mcg/ml, Morphine sulphate
- Keywords
- total knee replacement, orthopedic surgery, post operative analgesia, continuous epidural, patients controlled analgesia, morphine, combined spinal epidural anesthesia, anesthesia, analgesia, epidural marcaine, epidural fentanyl, pain
- Medical subject headings
- Pain, Postoperative, Osteoarthritis, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marcaine 0.166% + Fentanyl 3.33 mcg/mlDrug
Morphine sulphateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation
Total dose of rescue analgesics during first 24 hours post-operation
Secondary outcomes (4)
VAS (rest/movement) + total dose rescue analgesics after 24 hours post-operation until discharge
Patient outcome questionnaire
Physiotherapy performance VAS (rest/walking, passive extension, maximal angle, knee flexion/extension)
Adverse reactions, complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study startJan 2006
- Study completionMar 2007
Why it stopped: We believe regional anesth better for TKR,90% patients got epidural. Last year we started spinal morphine one shot, and found it very promissing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Ruth Edery, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270322
- Sponsor's protocol ID
- TKR-1.CTIL
- Status last verified
- May 2006
- First submitted
- 23 Dec 2005
- Last updated
- 11 Apr 2007
- Results posted
- No
Publications
Williams-Russo P, Sharrock NE, Haas SB, Insall J, Windsor RE, Laskin RS, Ranawat CS, Go G, Ganz SB. Randomized trial of epidural versus general anesthesia: outcomes after primary total knee replacement. Clin Orthop Relat Res. 1996 Oct;(331):199-208. doi: 10.1097/00003086-199610000-00028.
PubMed 8895639Forst J, Wolff S, Thamm P, Forst R. Pain therapy following joint replacement.A randomized study of patient-controlled analgesia versus conventional pain therapy. Arch Orthop Trauma Surg. 1999;119(5-6):267-70. doi: 10.1007/s004020050407.
PubMed 10447620Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
PubMed 10422923Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
PubMed 9661552Quality improvement guidelines for the treatment of acute pain and cancer pain. American Pain Society Quality of Care Committee. JAMA. 1995 Dec 20;274(23):1874-80. doi: 10.1001/jama.1995.03530230060032.
PubMed 7500539Foss NB, Kristensen MT, Kristensen BB, Jensen PS, Kehlet H. Effect of postoperative epidural analgesia on rehabilitation and pain after hip fracture surgery: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2005 Jun;102(6):1197-204. doi: 10.1097/00000542-200506000-00020.
PubMed 15915033
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
- ClinicalTrials.gov ID
- NCT00270322
- Acronym / sponsor ID
- TKR-1.CTIL
- Conditions
- Pain, Postoperative, Osteoarthritis
- Keywords
- total knee replacement, orthopedic surgery, post operative analgesia, continuous epidural, patients controlled analgesia, morphine, combined spinal epidural anesthesia, anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We believe regional anesth better for TKR,90% patients got epidural. Last year we started spinal morphine one shot, and found it very promissing.
- Enrolment
- 80 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 26 Dec 2005 (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.
The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.
Detailed description
Total knee replacement (TKR) is known to be one of the most painful surgical procedures. Many treatments have been used post TKR: IV opioids, epidural infusions, peripheral nerve blocks. No one method has been recognised as the best one.
In this study we will compare two well established methods of pain treatment:
- continuous infusion of local anesthetics + opioids into the epidural space,
- patient controlled analgesia with IV Morphine.
The study design is double blind.
Patients will have a combined spinal-epidural anesthesia for the operation and then will be connected to 2 different pumps, one to the epidural catheter and one to the intravenous catheter, for the first 24 hours post-operatively.
Pain scores, total analgesic medications other than study medications, adverse reactions to study medications, complications and patient satisfaction will be followed by blinded observers and compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent
- Age: 55 to 85 years
- Osteoarthritis
- Primary unilateral total knee replacement
- American Society of Anesthesiologists (ASA) I-III
Key exclusion criteria (12 listed)
- Any cause for knee replacement other than osteoarthritis
- Total knee revision (re-do)
- Any contraindication for regional anesthesia
- Abnormal coagulation studies
- Thrombocytopenia less than 100,000/cc
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 |
|---|---|---|
| Marcaine 0.166% + Fentanyl 3.33 mcg/ml | Drug | – |
| Morphine sulphate | Drug | – |
Primary outcome
Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation
Total dose of rescue analgesics during first 24 hours post-operation
4 secondary outcomes
VAS (rest/movement) + total dose rescue analgesics after 24 hours post-operation until discharge
Patient outcome questionnaire
Physiotherapy performance VAS (rest/walking, passive extension, maximal angle, knee flexion/extension)
Adverse reactions, complications
Results and safety
The study was stopped early (reason given: We believe regional anesth better for TKR,90% patients got epidural. Last year we started spinal morphine one shot, and found it very promissing.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2007.
- Background: PubMed 8895639Williams-Russo P, Sharrock NE, Haas SB, Insall J, Windsor RE, Laskin RS, Ranawat CS, Go G, Ganz SB. Randomized trial of epidural versus general anesthesia: outcomes after primary total knee replacement. Clin Orthop Relat Res. 1996 Oct;(331):199-208. doi: 10.1097/00003086-199610000-00028.
- Background: PubMed 10447620Forst J, Wolff S, Thamm P, Forst R. Pain therapy following joint replacement.A randomized study of patient-controlled analgesia versus conventional pain therapy. Arch Orthop Trauma Surg. 1999;119(5-6):267-70. doi: 10.1007/s004020050407.
- Background: PubMed 10422923Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
- Background: PubMed 9661552Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
- Background: PubMed 7500539Quality improvement guidelines for the treatment of acute pain and cancer pain. American Pain Society Quality of Care Committee. JAMA. 1995 Dec 20;274(23):1874-80. doi: 10.1001/jama.1995.03530230060032.
- Background: PubMed 15915033Foss NB, Kristensen MT, Kristensen BB, Jensen PS, Kehlet H. Effect of postoperative epidural analgesia on rehabilitation and pain after hip fracture surgery: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2005 Jun;102(6):1197-204. doi: 10.1097/00000542-200506000-00020.
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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.
Ruth Edery, MD principal investigator
Rambam Health Care Campus
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 Marcaine 0.166% + Fentanyl 3.33 mcg/ml and Morphine sulphate in people with Pain, Postoperative and Osteoarthritis, run by Rambam Health Care Campus at 1 site in Israel.
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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 11 Apr 2007. 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 Israel. 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?
The study was stopped early (reason given: We believe regional anesth better for TKR,90% patients got epidural. Last year we started spinal morphine one shot, and found it very promissing.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation. The study lists 2 primary outcomes in all. 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 NCT00270322, which also lists 6 linked publications.
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 11 Apr 2007.