Erector Spinae Block -Dexmedetomidine

NCT06264739 | Recruiting

• 1 other identifier: 22-12-23/2
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Acute Pain; Opioid Consumption

Outcome Measures

Primary Outcomes (1)

• opioid consumption

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

  24 hours

Secondary Outcomes (1)

• The Numeric Rating Scale (NRS)

  24 hours

Study Arms (2)

group 1

OTHER

Dexmedetomidine (dekstomid) infusion will be administered for intraoperative analgesia.

Drug: esp Dexmedetomidine (dekstomid)

group 2

OTHER

remifentanyl (ultiva) infusion will be administered for intraoperative analgesia.

Drug: esp remifentanyl (ultiva)

Interventions

esp Dexmedetomidine (dekstomid) DRUG

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.

group 1

esp remifentanyl (ultiva) DRUG

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.

group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent;
• years old
• ASA Physical Status 1-3;
• Patients planned for lumbar disc surgery

You may not qualify if:

• Rejection during registration
• Request for dismissal from employment
• Inability to give informed consent
• Emergency surgery
• Bleeding diathesis
• Chronic use of opioids
• Psychiatric disorders

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Ferdi Gülaştı

Aydin, 09020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ferdi gülasştı

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ferdi gülaştı

CONTACT

5054929650; ferdigulasti@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Blindness patients and those who follow up after surgery will not know which group is in the study.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized double blinding

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: February 20, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

TU (1)