NCT04945512

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 7, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

June 8, 2021

Last Update Submit

November 7, 2021

Conditions

OsteosarcomaAnalgesia

Keywords

epidural analgesialower extremity osteosarcoma

Outcome Measures

Primary Outcomes (2)

  • Opioid consumption

    miligram

    48 hours

  • Measurement of postoperative pain

    VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)

    48 hours

Secondary Outcomes (7)

  • Amount of peroperative bleeding

    During surgery

  • Amount of postoperative bleeding

    48 Hours

  • Postoperative complications

    postoperative period up to 3 days

  • Intensive care unit stay

    48 hours

  • Hospital stay

    72 hours

  • +2 more secondary outcomes

Study Arms (2)

Study group; Epidural catheter and PCA

EXPERIMENTAL

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

Control group; No block, IC PCA

NO INTERVENTION

Postoperative pain control will be achieved with intravenous morphine PCA.

Interventions

Epidural AnalgesiaPROCEDURE

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 group; Epidural catheter and PCA

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • infection at the injection site
  • coagulation disorder
  • patients with central nervous system related disease
  • septic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.

    PMID: 26509324RESULT

  • 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.

    PMID: 16291387RESULT

MeSH Terms

Conditions

OsteosarcomaAgnosia

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Gizem Toydemir, MD

    Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nur Canbolat, MD

CONTACT

+905325162583drnurekiz@gmail.com

Mehmet Büget, Assoc. Prof.

CONTACT

+905324133282mbuget@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study group and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Invastigator, M.D.

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 30, 2021

Study Start

November 7, 2021

Primary Completion

August 20, 2022

Study Completion

September 20, 2022

Last Updated

November 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)