Pre-post Erector Spine Plane Block-spinal Surgery

Opioid Use Clinical Trial

— pre-post-esp  

Official title:

The Effect of Erector Spinal Area (Esp) Block Applied Before or After Surgery on Postoperative Acute Pain and Quality of Recovery in Patients Undergoing Spinal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215053
• Other study ID #: 21-12-2023
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: January 2024
• Source: Aydin Adnan Menderes University
• Contact: ferdi Gülasti
• Phone: +905054929650
• Email: ferdigulasti[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Opioid Use
• Pain, Acute

Intervention

Other:
• 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% (MARCAINE), 10 ml will consist of lidocaine 2% (Aritmal), and 10 ml will consist of physiological saline.

Locations

Country	Name	City	State
Turkey	Ferdi Gülasti	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	recovery	The quality of recovery of patients at the preoperative and postoperative 24th hour will be evaluated with a scoring system (QoR-40).The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items).The total score and subscales of the QoR-40 are measured using a five-point Likert scale (for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed) and individual scores are then added together, with the minimum score being 40 points and the maximum score being 200 points.	24 hours
Primary	opioi consumption	Postoperative 30th minute, 1st, 6th, 12th, 18th. Patients' opioid consumption on the PCA will be recorded at the 24th and 24th hours.	24 hours
Secondary	nrs	Preoperative period and Postoperative 30th minute, 1st, 6th, 12th, 18th. And at the 24th hour, patients' pain levels and NRS scores will be recorded.	24 hours