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IRCT20210829052319N1 IRCT 2022-03-17 Karaj University of Medical Sciences Comparison of efficacy of two methods of epidural analgesia Comparison of the postoperative epidural analgesic efficacy between epidural catheter and surgical hemo-vac drain with epidural injection capability in posterior lumbar surgeries 2022-04-04 anticipated 52 Complete https://irct.ir/trial/59496 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Patients are randomly divided into two groups consisting of quadruple blocks using the non-blinded block randomization method. 3 بی دردی اپیدورال بعد از اعمال جراحی لومبار خلفی. Intervention 1: Intervention group: dexamethasone (4 mg) + ropivacaine (0.2%, 25 ml) + epinephrine (1:200000) using Hemo-vac drain with epidural drug delivery capability. The epidural injection is repeated every 6 hours until 48 hours after the surgery. Intervention 2: Control group: dexamethasone (4 mg) + ropivacaine (0.2%, 25 ml) + epinephrine (1:200000) using an epidural catheter. The epidural injection is repeated every 6 hours until 48 hours after the surgery. Yes - There is a plan to make this available What will be shared: Demographic data and measured investigation variables will be accessible. When: June. 21 2022 to Sep. 22, 2022 To whom: Only accredited investigators or resrarch institutes Conditions: Data analysis permission is given to confirm the outcomes of the study and outcomes other than mentioned in this study. Where to obtain: Mehdi Rezaee, Anesthesiology Departmant, Madani Hospital, Karaj.Alborz How to obtain: Email to : m.rezaei@abzums.ac .ir and request for investigation data، following confirmation of the individual's or institute's identity the data will become accessible through mailing. Comments:
public Mehdi Rezaee
Unit 5 , Floor 3 , No. 27 , West Rahimi Ave. , Mahan Blvd , Jahanshahr , Karaj
Karaj Iran (Islamic Republic of) 3143754843 +98 26 3420 7972 m.rezaei@abzums.ac.ir Karaj University of Medical Sciences scientific Mehdi Rezaee
Unit 5 , Floor 3 , No. 27 , West Rahimi Ave. , Mahan Blvd , Jahanshahr , Karaj
Karaj Iran (Islamic Republic of) 3143754843 +98 26 3420 7972 m.rezaei@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) written consent to participate in the study age 18 to 65 candidate for instrumentation in posterior lumbar spine surgeries ASA class I-II 18 years 65 years Both patients withholding consent infection tumor fracture in the area of surgery speech impairments mental retardation preoperative neurological disorders allergy to anesthetic drugs patients with pacemaker patients that have used ropivacaine, opioids, and NSAIDs one week before the surgery failure in epidural catheter placement during the surgery pregnancy nausea and vomiting severe hemodynamic changes such as bradycardia or blood pressure drop higher than 30% of average blood pressure seizure severe headache progressive paresthesia of the lower limbs decreased level of consciousness changes in respiratory rate and order G89.18 Other acute postprocedural pain Treatment - Devices Treatment - Devices Intervention group: dexamethasone (4 mg) + ropivacaine (0.2%, 25 ml) + epinephrine (1:200000) using Hemo-vac drain with epidural drug delivery capability. The epidural injection is repeated every 6 hours until 48 hours after the surgery. Control group: dexamethasone (4 mg) + ropivacaine (0.2%, 25 ml) + epinephrine (1:200000) using an epidural catheter. The epidural injection is repeated every 6 hours until 48 hours after the surgery. The level of pain at the state of rest. Timepoint: Before the surgery, 8, 16, 24, 32, 40, 48 hours, and 4 months after the surgery. Method of measurement: Asking the patient, based on visual analogue scale (0=no pain, 1-3=mild pain, 4-7=moderate pain, and 8-10=severe pain). The level of pain at the state of motion. Timepoint: Before the surgery, 8, 16, 24, 32, 40, 48 hours, and 4 months after the surgery. Method of measurement: Asking the patient, based on visual analogue scale (0=no pain, 1-3=mild pain, 4-7=moderate pain, and 8-10=severe pain). The level of patient satisfaction with pain management. Timepoint: Upon discharge from the hospital, and 4 months after the surgery. Method of measurement: Asking the patient, based on a 0 to 10 score (0=not satisfied, 1-3=relative satisfaction, 4-7=high level of satisfaction, and 8-10=completely satisfied). The level of surgeon satisfaction (i.e., operating environment and the rate of bleeding). Timepoint: At the end of the surgery. Method of measurement: Asking the surgeon, based on a 0 to 10 score (0-2=not satisfied, 3-5=low level of satisfaction, 6-8=relative satisfaction, and 9-10=completely satisfied). The time of starting to move. Timepoint: The time of starting to move. Method of measurement: Asking the nurse. The time to first analgesic request. Timepoint: The time to first analgesic request. Method of measurement: Asking the nurse. The amount of postoperative bleeding. Timepoint: 48 hours after the surgery. Method of measurement: Evaluation of blood volume in Hemovac drain during the first 48 hours after surgery minus the volume of drug solution injected into the surgical wound. Karaj University of Medical Sciences Approved 2021-12-06 Ethics committee of Alborz University of Medical Sciences Ethics Committee Office, Second Floor, Deputy of Research and Technology, Saffarian Alley, 45 Meters Golshahr Ave Karaj Alborz Iran (Islamic Republic of)