Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Epidural Analgesia Initiated in the Preoperative Period in Lower Extremity Osteosarcoma

Conditions
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Osteosarcoma, Analgesia

Intervention / Treatment
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* Procedure: Epidural Analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study group and control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group; Epidural catheter and PCA<br>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. | Procedure: Epidural Analgesia<br>* 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.<br>|
| No Intervention: Control group; No block, IC PCA<br>Postoperative pain control will be achieved with intravenous morphine PCA. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of peroperative bleeding | Mililiter | During surgery | 
| Amount of postoperative bleeding | Mililiter | 48 Hours | 
| 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] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural analgesia, lower extremity osteosarcoma