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Clinical trial

Comparison of the Effects of Remifentanil and Dexmedetomidine on Postoperative Acute Pain in Patients Who Received Erector Spina Plane Block in Spinal Surgeries

ID
Name
22-12-23/2
Description
Postoperative pain is common after spinal surgeries, including lumbar disc surgery. Surgical anesthesia and perioperative analgesic regimen are aimed at complete intraoperative amnesia, deep analgesia, effective control of autonomic responses and rapid discharge from the hospital. Although there are many studies on the use of these techniques for postoperative analgesia, the number of data comparing these techniques that can be used in meta-analyses is low. In our study, investigators aimed to compare the effects of remifentanil and dexmedetomidine accompanied by ESP block, which are different multimodal analgesia methods, on pain.
Trial arms
Trial start
2024-01-01
Estimated PCD
2025-01-01
Trial end
2026-01-01
Status
Recruiting
Treatment
esp Dexmedetomidine (dekstomid)
After anesthesia and surgical procedures, bilateral ESP block will be applied under ultrasonography guidance from the midline 3 cm lateral from the T10 level. After cleaning the area with povidone-iodine before the block, the T10 transverse protrusion will be determined using a linear ultrasound probe. Local anesthetic will be applied between the transverse process and the erector spinae muscle with the help of an insulated needle designed for peripheral block procedures. The location of the needle will be confirmed by hydrodissection with physiological saline without local anesthesia. After the location of the needle is confirmed, 20 ml of LA and saline mixture will be applied and the same process will be repeated in the contralateral side. Of the total 40 ml LA, 20 ml will consist of bupivacaine 0.5% (marcaine), 10 ml will consist of lidocaine 2% (aritmal), and 10 ml will consist of physiological saline.
Arms:
group 1
esp remifentanyl (ultiva)
After anesthesia and surgical procedures, bilateral ESP block will be applied under ultrasonography guidance from the midline 3 cm lateral from the T10 level. After cleaning the area with povidone-iodine before the block, the T10 transverse protrusion will be determined using a linear ultrasound probe. Local anesthetic will be applied between the transverse process and the erector spinae muscle with the help of an insulated needle designed for peripheral block procedures. The location of the needle will be confirmed by hydrodissection with physiological saline without local anesthesia. After the location of the needle is confirmed, 20 ml of LA and saline mixture will be applied and the same process will be repeated in the contralateral side. Of the total 40 ml LA, 20 ml will consist of bupivacaine 0.5% (marcaine), 10 ml will consist of lidocaine 2% (aritmal), and 10 ml will consist of physiological saline.
Arms:
group 2
Size
74
Primary endpoint
opioid consumption
24 hours
Eligibility criteria
Inclusion Criteria: * Written informed consent; * 18-75 years old * ASA Physical Status 1-3; * Patients planned for lumbar disc surgery Exclusion Criteria: * Rejection during registration * Request for dismissal from employment * Inability to give informed consent * Emergency surgery * Bleeding diathesis * Chronic use of opioids * Psychiatric disorders
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomized double blinding', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Blindness patients and those who follow up after surgery will not know which group is in the study.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 74, 'type': 'ESTIMATED'}}
Updated at
2024-02-20

1 organization

2 products

2 indications

Organization
Aydin Adnan Menderes University
Product
Dexmedetomidine
Indication
Postoperative Acute Pain
Indication
Opioid Consumption
Product
Esp Remifentanyl