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Clinical Trials/NCT04945512
NCT04945512
Unknown
Not Applicable

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

Istanbul University1 site in 1 country28 target enrollmentNovember 7, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteosarcoma
Sponsor
Istanbul University
Enrollment
28
Locations
1
Primary Endpoint
Opioid consumption
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 7, 2021
End Date
September 20, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nur Canbolat

Principle Invastigator, M.D.

Istanbul University

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Beck Depression Inventory (BDI)(Will be done 2 times 1- on pre-operative hospitalization 2- in the 1st month follow-up after surgery])
  • Amount of peroperative bleeding(During surgery)
  • Amount of postoperative bleeding(48 Hours)
  • Patient satisfaction(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)
  • Postoperative complications(postoperative period up to 3 days)
  • Intensive care unit stay(48 hours)
  • Hospital stay(72 hours)

Study Sites (1)

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