Efficacy of Epidural Analgesia in Lower Extremity Osteosarcoma
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|ClinicalTrials.gov Identifier: NCT04945512|
Recruitment Status : Recruiting
First Posted : June 30, 2021
Last Update Posted : June 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma Analgesia||Procedure: Epidural Analgesia||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Study group and control group|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Epidural Analgesia Initiated in the Preoperative Period in Lower Extremity Osteosarcoma|
|Estimated Study Start Date :||August 20, 2021|
|Estimated Primary Completion Date :||August 20, 2022|
|Estimated Study Completion Date :||September 20, 2022|
Experimental: Study group; Epidural catheter and PCA
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.
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.
No Intervention: Control group; No block, IC PCA
Postoperative pain control will be achieved with intravenous morphine PCA.
- 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)
- Amount of peroperative bleeding [ Time Frame: During surgery ]Mililiter
- Amount of postoperative bleeding [ Time Frame: 48 Hours ]Mililiter
- Postoperative complications [ Time Frame: postoperative period up to 3 days ]yes/no
- Intensive care unit stay [ Time Frame: 48 hours ]hours
- Hospital stay [ Time Frame: 72 hours ]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 ]5-point Likert scale: very satisfied (= 5), satisfied (= 4), neutral (= 3), dissatisfied (= 2) and very dissatisfied (= 1)
- 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] ]0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04945512
|Contact: Nur Canbolat, MDemail@example.com|
|Contact: Mehmet Büget, Assoc. Prof.||+firstname.lastname@example.org|
|Istanbul University, Faculty of Medicine||Recruiting|
|Istanbul, Fatih, Turkey, 34093|
|Contact: Nur Canbolat, MD email@example.com|
|Contact: Mehmet Büget, Assoc. Prof firstname.lastname@example.org|
|Principal Investigator: Nur Canbolat, MD|
|Principal Investigator: Mehmet Büget, Assoc. Prof|
|Principal Investigator: Gizem Toydemir, MD|
|Principal Investigator:||Gizem Toydemir, MD||Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology|