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Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04945512
Recruitment Status : Recruiting
First Posted : June 30, 2021
Last Update Posted : June 30, 2021
Information provided by (Responsible Party):
Nur Canbolat, Istanbul University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteosarcoma Analgesia Procedure: Epidural Analgesia Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study group and control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Epidural Analgesia Initiated in the Preoperative Period in Lower Extremity Osteosarcoma
Estimated Study Start Date : August 20, 2021
Estimated Primary Completion Date : August 20, 2022
Estimated Study Completion Date : September 20, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Study group; Epidural catheter and PCA
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
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.

No Intervention: Control group; No block, IC PCA
Postoperative pain control will be achieved with intravenous morphine PCA.

Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: 48 hours ]

  2. Measurement of postoperative pain [ Time Frame: 48 hours ]
    VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)

Secondary Outcome Measures :
  1. Amount of peroperative bleeding [ Time Frame: During surgery ]

  2. Amount of postoperative bleeding [ Time Frame: 48 Hours ]

  3. Postoperative complications [ Time Frame: postoperative period up to 3 days ]

  4. Intensive care unit stay [ Time Frame: 48 hours ]

  5. Hospital stay [ Time Frame: 72 hours ]

  6. Patient satisfaction [ Time Frame: 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 ]
    5-point Likert scale: very satisfied (= 5), satisfied (= 4), neutral (= 3), dissatisfied (= 2) and very dissatisfied (= 1)

  7. Beck Depression Inventory (BDI) [ Time Frame: Will be done 2 times 1- on pre-operative hospitalization 2- in the 1st month follow-up after surgery] ]
    0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04945512

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Contact: Nur Canbolat, MD +905325162583
Contact: Mehmet Büget, Assoc. Prof. +905324133282

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Istanbul University, Faculty of Medicine Recruiting
Istanbul, Fatih, Turkey, 34093
Contact: Nur Canbolat, MD   
Contact: Mehmet Büget, Assoc. Prof   
Principal Investigator: Nur Canbolat, MD         
Principal Investigator: Mehmet Büget, Assoc. Prof         
Principal Investigator: Gizem Toydemir, MD         
Sponsors and Collaborators
Istanbul University
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Principal Investigator: Gizem Toydemir, MD Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Publications of Results:
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Responsible Party: Nur Canbolat, Principle Invastigator, M.D., Istanbul University Identifier: NCT04945512    
Other Study ID Numbers: 2020/1831
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nur Canbolat, Istanbul University:
epidural analgesia
lower extremity osteosarcoma
Additional relevant MeSH terms:
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Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type