Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945512
• Other study ID #: 2020/1831
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: November 2021
• Source: Istanbul University
• Contact: Nur Canbolat, MD
• Phone: +905325162583
• Email: drnurekiz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: September 20, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Osteosarcoma

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul University, Faculty of Medicine	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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

Weinbroum AA. Superiority of postoperative epidural over intravenous patient-controlled analgesia in orthopedic oncologic patients. Surgery. 2005 Nov;138(5):869-76. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	miligram	48 hours
Primary	Measurement of postoperative pain	VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)	48 hours
Secondary	Amount of peroperative bleeding	Mililiter	During surgery
Secondary	Amount of postoperative bleeding	Mililiter	48 Hours
Secondary	Postoperative complications	yes/no	postoperative period up to 3 days
Secondary	Intensive care unit stay	hours	48 hours
Secondary	Hospital stay	hours	72 hours
Secondary	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
Secondary	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]