Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma

Not Applicable

• Conditions: Analgesia; Osteosarcoma

• Registration Number: NCT04945512
• Lead Sponsor: Istanbul University

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 Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-06-30
• Status Verified: 2021-11
• Study Start: 2021-11-07
• Last Update Submitted: 2021-11-07
• Last Update Posted: 2021-11-09
• Primary Completion: 2022-08-20
• Study Completion: 2022-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory (BDI)	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
Amount of postoperative bleeding	48 Hours	Mililiter
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	5-point Likert scale: very satisfied (= 5), satisfied (= 4), neutral (= 3), dissatisfied (= 2) and very dissatisfied (= 1)
Intensive care unit stay	48 hours	hours
Hospital stay	72 hours	hours
Amount of peroperative bleeding	During surgery	Mililiter
Postoperative complications	postoperative period up to 3 days	yes/no

Trial Locations

Locations (1)

Istanbul University, Faculty of Medicine; 🇹🇷 Istanbul, Fatih, Turkey