OsteosarcomaNCT04945512
Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma
A study testing Epidural Analgesia in people with Osteosarcoma and Analgesia, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteosarcoma, Analgesia
- What is being tested?
- Epidural Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2021to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- infection at the injection site
- coagulation disorder
- patients with central nervous system related disease
- septic patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University, Faculty of Medicine
Istanbul, Fatih, 34093
Nur Canbolat, MD, drnurekiz@gmail.com
Mehmet Büget, Assoc. Prof, mbuget@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteosarcoma, Analgesia
- Being tested
- Epidural Analgesia
- Keywords
- epidural analgesia, lower extremity osteosarcoma
- Medical subject headings
- Osteosarcoma, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural AnalgesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group; Epidural catheter and PCA | Experimental | 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. Receives: Procedure: Epidural Analgesia |
| Control group; No block, IC PCA | No intervention | Postoperative pain control will be achieved with intravenous morphine PCA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
miligram
Measured: 48 hours
Measurement of postoperative pain
VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)
Measured: 48 hours
Secondary outcomes (7)
Amount of peroperative bleeding
Mililiter
Measured: During surgery
Amount of postoperative bleeding
Mililiter
Measured: 48 Hours
Postoperative complications
yes/no
Measured: postoperative period up to 3 days
Intensive care unit stay
hours
Measured: 48 hours
Hospital stay
hours
Measured: 72 hours
Patient satisfaction
5-point Likert scale: very satisfied (= 5), satisfied (= 4), neutral (= 3), dissatisfied (= 2) and very dissatisfied (= 1)
Measured: 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
Measured: Will be done 2 times 1- on pre-operative hospitalization 2- in the 1st month follow-up after surgery]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start7 Nov 2021
- Primary completion20 Aug 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study group and control group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Canbolat, Istanbul University
- Investigators
- Gizem Toydemir, MD, Principal investigator, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945512
- Sponsor's protocol ID
- 2020/1831
- Status last verified
- Nov 2021
- First submitted
- 8 Jun 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
PubMed 26509324Weinbroum 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.
PubMed 16291387
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Epidural Analgesia Initiated in the Preoperative Period in Lower Extremity Osteosarcoma
- ClinicalTrials.gov ID
- NCT04945512
- Acronym / sponsor ID
- 2020/1831
- Conditions
- Osteosarcoma, Analgesia
- Keywords
- epidural analgesia, lower extremity osteosarcoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 7 Nov 2021 (actual)
- Primary completion
- 20 Aug 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study group and control group
| Arm | Type | Receives |
|---|---|---|
| Study group; Epidural catheter and PCA | Experimental | Procedure: Epidural AnalgesiaEpidural 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. |
| Control group; No block, IC PCA | No intervention | –Postoperative pain control will be achieved with intravenous morphine PCA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- infection at the injection site
- coagulation disorder
- patients with central nervous system related disease
- septic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural AnalgesiaIn 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. | Procedure or surgery | Study group; Epidural catheter and PCA |
Primary outcome
Opioid consumption
Time frame: 48 hours
miligram
Measurement of postoperative pain
Time frame: 48 hours
VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)
7 secondary outcomes
Amount of peroperative bleeding
Time frame: During surgery
Amount of postoperative bleeding
Time frame: 48 Hours
Postoperative complications
Time frame: postoperative period up to 3 days
Intensive care unit stay
Time frame: 48 hours
Hospital stay
Time frame: 72 hours
Patient satisfaction
Time frame: 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)
Time frame: Will be done 2 times 1- on pre-operative hospitalization 2- in the 1st month follow-up after surgery]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Results publication: PubMed 26509324Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
- Results publication: PubMed 16291387Weinbroum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Toydemir, MD principal investigator
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Analgesia in people with Osteosarcoma and Analgesia, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nur Canbolat, MD (+905325162583, drnurekiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04945512, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.