Pre-post Erector Spine Plane Block-spinal Surgery

Not Applicable

Recruiting

• Conditions: Opioid Use; Pain, Acute

• Registration Number: NCT06215053
• Lead Sponsor: Aydin Adnan Menderes University

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.

Study Timeline

• Study First Submitted: 2023-12-21
• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
opioi consumption	24 hours	Postoperative 30th minute, 1st, 6th, 12th, 18th. Patients' opioid consumption on the PCA will be recorded at the 24th and 24th hours.

Secondary Outcome Measures

Name	Time	Method
nrs	24 hours	Preoperative period and Postoperative 30th minute, 1st, 6th, 12th, 18th. And at the 24th hour, patients' pain levels and NRS scores will be recorded.

Trial Locations

Locations (1)

Ferdi Gülaştı; 🇹🇷 Aydın, Turkey