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Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma

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ClinicalTrials.gov Identifier: NCT04945512
Recruitment Status : Recruiting
First Posted : June 30, 2021
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Nur Canbolat, Istanbul University

Tracking Information
First Submitted Date  ICMJE June 8, 2021
First Posted Date  ICMJE June 30, 2021
Last Update Posted Date June 30, 2021
Estimated Study Start Date  ICMJE August 20, 2021
Estimated Primary Completion Date August 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2021)
  • Opioid consumption [ Time Frame: 48 hours ]
    miligram
  • Measurement of postoperative pain [ Time Frame: 48 hours ]
    VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2021)
  • Amount of peroperative bleeding [ Time Frame: During surgery ]
    Mililiter
  • Amount of postoperative bleeding [ Time Frame: 48 Hours ]
    Mililiter
  • Postoperative complications [ Time Frame: postoperative period up to 3 days ]
    yes/no
  • Intensive care unit stay [ Time Frame: 48 hours ]
    hours
  • Hospital stay [ Time Frame: 72 hours ]
    hours
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma
Official Title  ICMJE Efficacy of Epidural Analgesia Initiated in the Preoperative Period in Lower Extremity Osteosarcoma
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Study group and control group
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteosarcoma
  • Analgesia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Epidural Analgesia
  • No Intervention: Control group; No block, IC PCA
    Postoperative pain control will be achieved with intravenous morphine PCA.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2021)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 20, 2022
Estimated Primary Completion Date August 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nur Canbolat, MD +905325162583 drnurekiz@gmail.com
Contact: Mehmet Büget, Assoc. Prof. +905324133282 mbuget@yahoo.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04945512
Other Study ID Numbers  ICMJE 2020/1831
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nur Canbolat, Istanbul University
Study Sponsor  ICMJE Istanbul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gizem Toydemir, MD Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
PRS Account Istanbul University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP