Analgesia Clinical Trial
Official title:
Efficacy of Epidural Analgesia Initiated in the Preoperative Period in Lower Extremity Osteosarcoma
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.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | September 20, 2022 |
Est. primary completion date | August 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - accepting the study protocol, - age older than 18 years and younger than 80 years, - undergoing lower extremity osteosarcoma surgery - the American Society of Anesthesiologist (ASA) physical status of I-II-III Exclusion Criteria: - infection at the injection site - coagulation disorder - patients with central nervous system related disease - septic patients |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University, Faculty of Medicine | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Istanbul University |
Turkey,
Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366. Review. — View Citation
Weinbroum AA. Superiority of postoperative epidural over intravenous patient-controlled analgesia in orthopedic oncologic patients. Surgery. 2005 Nov;138(5):869-76. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid consumption | miligram | 48 hours | |
Primary | Measurement of postoperative pain | VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable) | 48 hours | |
Secondary | Amount of peroperative bleeding | Mililiter | During surgery | |
Secondary | Amount of postoperative bleeding | Mililiter | 48 Hours | |
Secondary | Postoperative complications | yes/no | postoperative period up to 3 days | |
Secondary | Intensive care unit stay | hours | 48 hours | |
Secondary | Hospital stay | hours | 72 hours | |
Secondary | 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 | |
Secondary | 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] |
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