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Erector Spinae Block -Dexmedetomidine

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06264739
Acronym
esp -dex
Enrollment
74
Registered
2024-02-20
Start date
2024-01-01
Completion date
2026-01-01
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Consumption, Postoperative Acute Pain

Brief summary

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.

Detailed description

investigators propose a randomized double-blind study comparing the use of intraoperative dexmedetomidine (Group D) for analgesic purposes with the use of intraoperative remifentanil (Group R) in patients undergoing ESP block for spinal surgery. The clinic's routine anesthesia protocol will be applied to the patient. Anesthesia will not be interfered with. Group 1: Dexmedetomidine infusion will be administered for intraoperative analgesia Group 2: Remifentanil infusion will be administered for intraoperative analgesia Routine anesthesia protocol in our clinic: patient is induced with fentanyl 1μg/kg IV and propofol 1.5 to 2 mg/kg IV, rocuronium 0.6 mg/kg IV. After putting the patients to sleep, ESP block is applied to the patients for postoperative pain management. The peroperative analgesia plan will be applied the same to all patients. In this protocol, intravenous paracetamol was determined as 1 g and tramadol was determined as 1 mg/kg. Then it is paracetamol every eight hours and tramadol from PCA. At the end of the operation, patients' pain levels will be determined and recorded with the Numeric Rating Scale (NRS) system at 4-hour intervals in the first 24 hours postoperatively. Demographic data to be obtained will include height (cm), weight (kg), age (years), gender, physical condition (ASA) and specific procedure type will be recorded. Patients will be asked about tobacco, alcohol use and drug use. They will also be asked about their medical history, including lung disease, kidney disease, diabetes mellitus, neurological disease, chronic pain conditions, previous surgery or stent placement, and medications. Current preoperative laboratory tests and medication list will be recorded. Preoperative pain scores, NRS, and opioid use will be recorded. Pain levels will be determined and recorded using the Numeric Rating Scale (NRS) system during the first 24 hours postoperatively. Additionally, opioid consumption will be evaluated from the PCA device used postoperatively. Patients excluded for any reason, including technical considerations or contraindications, will be enrolled. How much intraoperative bleeding occurred, how much blood and blood products were transfused to the patient, and the duration of surgery will be recorded. F. DATA ANALYSIS Statistical analyzes will be performed using SPSS. Before statistical testing, each continuous variable will be analyzed using the Kolmogorov-Smirnov test to determine whether it has a normal distribution. Continuous data are described as mean (SD) or median (25% and 75% percentiles) and will be analyzed by independent t test or Mann-Whitney U test, respectively. Categorical data were described as frequency or percentage and will be analyzed using the chi-square test. One-way ANOVA with multiple comparison test will be used for comparison between groups. For periods between first PCA triggers, data will be analyzed using the Kaplan-Meier survival method and compare groups using the log-rank test. Results will be expressed as mean ± SD or absolute number, and a P value \< 0.05 will be considered statistically significant. G. NUMBER OF SAMPLES Shobana Rajan et al. Based on their study, investigators calculated a sample size of 37 patients per group by setting alfa equal to 0.005 and beta equal to 0.8.

Interventions

DRUGesp 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.

DRUGesp 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.

Sponsors

Aydin Adnan Menderes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Masking description

Blindness patients and those who follow up after surgery will not know which group is in the study.

Intervention model description

randomized double blinding

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
opioid consumption24 hoursPatients' opioid consumption on the PCA device will be recorded at 0, 3, 6, 12, 18, and 24 hours postoperatively.

Secondary

MeasureTime frameDescription
The Numeric Rating Scale (NRS)24 hoursPreoperative period and Postoperative 30th minute, 1st, 6th, 12th, 18th. And at the 24th hour, patients' pain levels and NRS scores will be recorded. At the end of the operation, patients' pain levels will be determined and recorded using the Numeric Rating Scale (NRS) system at intervals in the first 24 hours postoperatively. NRS; It is a pain intensity determination system based on the system of having the person say a point between 0 (no pain), 10 (unbearable pain) and 10 (unbearable pain) to describe his/her pain.

Countries

Turkey (Türkiye)

Contacts

Primary Contactferdi gülaştı
ferdigulasti@gmail.com5054929650

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026