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Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04945512
Enrollment
28
Registered
2021-06-30
Start date
2021-11-07
Completion date
2022-09-20
Last updated
2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Osteosarcoma

Keywords

epidural analgesia, lower extremity osteosarcoma

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.

Interventions

PROCEDUREEpidural 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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Study group and control group

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Opioid consumption48 hoursmiligram
Measurement of postoperative pain48 hoursVAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)

Secondary

MeasureTime frameDescription
Postoperative complicationspostoperative period up to 3 daysyes/no
Intensive care unit stay48 hourshours
Amount of peroperative bleedingDuring surgeryMililiter
Patient satisfactionWill 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 surgery5-point Likert scale: very satisfied (= 5), satisfied (= 4), neutral (= 3), dissatisfied (= 2) and very dissatisfied (= 1)
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
Hospital stay72 hourshours
Amount of postoperative bleeding48 HoursMililiter

Countries

Turkey (Türkiye)

Contacts

Primary ContactNur Canbolat, MD
drnurekiz@gmail.com+905325162583
Backup ContactMehmet Büget, Assoc. Prof.
mbuget@yahoo.com+905324133282

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026