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Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma

Primary Purpose

Osteosarcoma, Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Epidural Analgesia
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring epidural analgesia, lower extremity osteosarcoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University, Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group; Epidural catheter and PCA

Control group; No block, IC PCA

Arm Description

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.

Postoperative pain control will be achieved with intravenous morphine PCA.

Outcomes

Primary Outcome Measures

Opioid consumption
miligram
Measurement of postoperative pain
VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)

Secondary Outcome Measures

Amount of peroperative bleeding
Mililiter
Amount of postoperative bleeding
Mililiter
Postoperative complications
yes/no
Intensive care unit stay
hours
Hospital stay
hours
Patient satisfaction
5-point Likert scale: very satisfied (= 5), satisfied (= 4), neutral (= 3), dissatisfied (= 2) and very dissatisfied (= 1)
Beck Depression Inventory (BDI)
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression

Full Information

First Posted
June 8, 2021
Last Updated
November 7, 2021
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04945512
Brief Title
Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma
Official Title
Efficacy of Epidural Analgesia Initiated in the Preoperative Period in Lower Extremity Osteosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2021 (Actual)
Primary Completion Date
August 20, 2022 (Anticipated)
Study Completion Date
September 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma, Analgesia
Keywords
epidural analgesia, lower extremity osteosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study group and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group; Epidural catheter and PCA
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group; No block, IC PCA
Arm Type
No Intervention
Arm Description
Postoperative pain control will be achieved with intravenous morphine PCA.
Intervention Type
Procedure
Intervention Name(s)
Epidural Analgesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid consumption
Description
miligram
Time Frame
48 hours
Title
Measurement of postoperative pain
Description
VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Amount of peroperative bleeding
Description
Mililiter
Time Frame
During surgery
Title
Amount of postoperative bleeding
Description
Mililiter
Time Frame
48 Hours
Title
Postoperative complications
Description
yes/no
Time Frame
postoperative period up to 3 days
Title
Intensive care unit stay
Description
hours
Time Frame
48 hours
Title
Hospital stay
Description
hours
Time Frame
72 hours
Title
Patient satisfaction
Description
5-point Likert scale: very satisfied (= 5), satisfied (= 4), neutral (= 3), dissatisfied (= 2) and very dissatisfied (= 1)
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
Title
Beck Depression Inventory (BDI)
Description
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression
Time Frame
Will be done 2 times 1- on pre-operative hospitalization 2- in the 1st month follow-up after surgery]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nur Canbolat, MD
Phone
+905325162583
Email
drnurekiz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Büget, Assoc. Prof.
Phone
+905324133282
Email
mbuget@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gizem Toydemir, MD
Organizational Affiliation
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University, Faculty of Medicine
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nur Canbolat, MD
Email
drnurekiz@gmail.com
First Name & Middle Initial & Last Name & Degree
Mehmet Büget, Assoc. Prof
Email
mbuget@yahoo.com
First Name & Middle Initial & Last Name & Degree
Nur Canbolat, MD
First Name & Middle Initial & Last Name & Degree
Mehmet Büget, Assoc. Prof
First Name & Middle Initial & Last Name & Degree
Gizem Toydemir, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26509324
Citation
Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
Results Reference
result
PubMed Identifier
16291387
Citation
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.
Results Reference
result

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Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma

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