Pre-post Erector Spine Plane Block-spinal Surgery

NCT ID: NCT06215053

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-01-01

Brief Summary

Spinal surgery patients generally have chronic pain in the preoperative period and are exposed to widespread and severe acute pain postoperatively. In spinal surgery patients, providing postoperative analgesia is important not only for the patient's comfort but also for preventing the negative effects of pain on the systems, allowing early mobilization, reducing hospital stay and especially reducing chronic pain syndrome.

Although ESP block is routinely used in spinal analgesia, the answer to the question of whether investigators should perform the block after putting the patient to sleep or before waking the patient after completing the surgery is not clear. Preference varies among anesthesiologists.YOU investigators propose a randomized double-blind study comparing patients who underwent ESP block before surgery (Group 1) with patients who underwent ESP block after surgery (Group 2).

Detailed Description

investigators propose a randomized double-blind study comparing patients who underwent ESP block before surgery (Group 1) with patients who underwent ESP block after surgery (Group 2). Blind patients and postoperative follow-ups will not know which group the patient is in the study. The study will be conducted at Adnan Menderes University hospital with the approval of the ethics committee and the written consent of the patients. The study will be registered on the ClinicalTrials.gov website before the first patient is enrolled.

Preoperative Visit Documentation of eligibility and consent will be confirmed at the preoperative visit. During this visit, patients will provide demographic and historical medical information, including information regarding medication use. They will fill out the QR-40 quality compilation survey form.

intraoperative The clinic's routine anesthesia protocol will be applied to the patient. Anesthesia will not be interfered with.

Group 1: Following induction of anesthesia, ESP block will be performed before the surgery begins, Group 2: ESP block will be performed before waking the patient at the end of surgery.

Postoperative 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 postoperative intervals.

The quality of recovery (QoR-40) of both groups of patients at the 24th postoperative hour will be evaluated with a scoring system.

Conditions

Opioid Use; Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

group 1

Following induction of anesthesia, ESP block will be performed before the surgery begins

Group Type: OTHER

erector spine plane block

Intervention Type: OTHER

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% (MARCAİNE), 10 ml will consist of lidocaine 2% (Aritmal), and 10 ml will consist of physiological saline.

group 2

An ESP block will be performed before waking the patient at the end of surgery.

Group Type: OTHER

erector spine plane block

Intervention Type: OTHER

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% (MARCAİNE), 10 ml will consist of lidocaine 2% (Aritmal), and 10 ml will consist of physiological saline.

Interventions

erector spine plane block

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% (MARCAİNE), 10 ml will consist of lidocaine 2% (Aritmal), and 10 ml will consist of physiological saline.

Intervention Type: OTHER

Other Intervention Names

esp block

Eligibility Criteria

Inclusion Criteria

1. Spinal surgery performed under elective conditions

2. ASA I-III 3.18-75 years old

Exclusion Criteria

1. Rejection during registration

2. Request for dismissal from employment

3. Inability to give informed consent

4. Emergency surgery

5. Bleeding diathesis

6. Presence of contraindications to the LA agents used in this study

7. Chronic use of opioids

8. Psychiatric disorders

9. Presence of infection at the injection site

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

ferdi gülaştı

anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ferdi Gülaştı

Aydin, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

ferdi Gülaştı

Role: CONTACT

ferdigulasti@icloud.com

+905054929650

Ferdi Gülaştı

Role: CONTACT

ferdigulasti@icloud.com

Facility Contacts

Ferdi Gülaştı

Role: primary

ferdigulasti@gmail.com

Other Identifiers

21-12-2023

Identifier Type: -

Identifier Source: org_study_id