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We believe regional anesth better for TKR,90% patients got epidural. Last year we started spinal morphine one shot, and found it very promissing.
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The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marcaine 0.166% + Fentanyl 3.33 mcg/ml | Drug | |||
| Morphine sulphate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation | ||
| Total dose of rescue analgesics during first 24 hours post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Edery, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | 31096 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8895639 | Background | 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. | |
| 10447620 | Background |
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| Adverse reactions, complications |
| Forst 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. |
| 10422923 | Background | Capdevila 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. |
| 9661552 | Background | Singelyn 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. |
| 7500539 | Background | Quality 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. |
| 15915033 | Background | Foss 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. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010003 | Osteoarthritis |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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