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In this study, the investigators aim to reduce complications in orthopedic malignancy surgeries and to increase the quality of life of patients who will be operated on.
In the preoperative period, the participants will be taken to the block room. The participants will be monitored, standard sedation will be applied.
Patients in the first group will be provided with preoperative and peroperative analgesia with an epidural catheter. The second group patient will be get no block. Afterwards, both groups will be operated under similar general anesthesia conditions. A patient-controlled analgesia device will be attached to each group of participants and their postoperative follow-up will be made.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group; Epidural catheter and PCA | Experimental | Epidural catheter will be placed in the preoperative period. After induction, 10 ml of 0.25% bupivacaine will be administered through the epidural catheter and bupivacaine PCA will be started. |
|
| Control group; No block, IC PCA | No Intervention | Postoperative pain control will be achieved with intravenous morphine PCA. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Analgesia | Procedure | In the anesthesia preparation room, an epidutal catheter will be placed with a toue needle through the L4-5 spinal space. After induction of general anesthesia, 10 ml of 0.25% bupivacaine will be injected through the epidural catheter.Afterwards, peroperative and postoperative analgesia will be provided with epidural PCA. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | miligram | 48 hours |
| Measurement of postoperative pain | VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of peroperative bleeding | Mililiter | During surgery |
| Amount of postoperative bleeding | Mililiter | 48 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nur Canbolat, MD | Contact | +905325162583 | drnurekiz@gmail.com | |
| Mehmet Büget, Assoc. Prof. | Contact | +905324133282 | mbuget@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Gizem Toydemir, MD | Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University, Faculty of Medicine | Recruiting | Istanbul | Fatih | 34093 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26509324 | Result | Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366. | |
| 16291387 | Result | Weinbroum AA. Superiority of postoperative epidural over intravenous patient-controlled analgesia in orthopedic oncologic patients. Surgery. 2005 Nov;138(5):869-76. doi: 10.1016/j.surg.2005.05.004. |
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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Study group and control group
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|
| Postoperative complications | yes/no | postoperative period up to 3 days |
| Intensive care unit stay | hours | 48 hours |
| Hospital stay | hours | 72 hours |
| Patient satisfaction | 5-point Likert scale: very satisfied (= 5), satisfied (= 4), neutral (= 3), dissatisfied (= 2) and very dissatisfied (= 1) | Will be done 3 times 1- a day after surgery 2- in the 1st week follow up after surgery 3- in the 1st month follow-up after surgery |
| Beck Depression Inventory (BDI) | 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression | Will be done 2 times 1- on pre-operative hospitalization 2- in the 1st month follow-up after surgery] |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |