Clinical trial NCT04945512: Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma
Official title: Efficacy of Epidural Analgesia Initiated in the Preoperative Period in Lower Extremity Osteosarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteosarcoma
Analgesia
Keywords: epidural analgesia
lower extremity osteosarcoma
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study group and control group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Opioid consumption
timeFrame: 48 hours
measure: Measurement of postoperative pain
timeFrame: 48 hours
Secondary outcomes:
measure: Amount of peroperative bleeding
timeFrame: During surgery
measure: Amount of postoperative bleeding
timeFrame: 48 Hours
measure: Postoperative complications
timeFrame: postoperative period up to 3 days
measure: Intensive care unit stay
timeFrame: 48 hours
measure: Hospital stay
timeFrame: 72 hours
measure: Patient satisfaction
timeFrame: 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
measure: Beck Depression Inventory (BDI)
timeFrame: Will be done 2 times 1- on pre-operative hospitalization 2- in the 1st month follow-up after surgery]
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Faculty of Medicine
state: Fatih
Study officials:
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
name: Gizem Toydemir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
citation: 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.