Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma

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

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Osteosarcoma
• Intervention / Treatment: Procedure: Epidural Analgesia

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: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehmet Büget, Assoc. Prof.; Phone Number: +905324133282; Email: mbuget@yahoo.com

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Recruiting
      • Istanbul University, Faculty of Medicine
      • Contact: Mehmet Büget, Assoc. Prof; Email: mbuget@yahoo.com
      • Principal Investigator: Nur Canbolat, MD
      • Principal Investigator: Mehmet Büget, Assoc. Prof
      • Principal Investigator: Gizem Toydemir, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of postoperative pain	VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)	48 hours
Opioid consumption	miligram	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of peroperative bleeding	Mililiter	During surgery
Amount of postoperative bleeding	Mililiter	48 Hours
Postoperative complications	yes/no	postoperative period up to 3 days
Intensive care unit stay	hours	48 hours
Hospital stay	hours	72 hours
Patient satisfaction	5-point Likert scale: very satisfied (= 5), satisfied (= 4), neutral (= 3), dissatisfied (= 2) and very dissatisfied (= 1)	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
Beck Depression Inventory (BDI)	0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression	Will be done 2 times 1- on pre-operative hospitalization 2- in the 1st month follow-up after surgery]

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Gizem Toydemir, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2021
• Primary Completion (Anticipated): August 20, 2022
• Study Completion (Anticipated): September 20, 2022

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 7, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: epidural analgesia; lower extremity osteosarcoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma; Osteosarcoma
• Other Study ID Numbers: 2020/1831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No