NCT06215053

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2025

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

December 21, 2023

Last Update Submit

April 9, 2026

Conditions

Keywords

erector spinae blockpostoperative painspinal surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • nrs

    24 hours

  • recovery

    24 hours

Study Arms (2)

group 1

OTHER

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

Other: erector spine plane block

group 2

OTHER

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

Other: erector spine plane block

Interventions

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.

Also known as: esp block
group 1group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal surgery performed under elective conditions
  • ASA I-III 3.18-75 years old

You may not qualify if:

  • Rejection during registration
  • Request for dismissal from employment
  • Inability to give informed consent
  • Emergency surgery
  • Bleeding diathesis
  • Presence of contraindications to the LA agents used in this study
  • Chronic use of opioids
  • Psychiatric disorders
  • Presence of infection at the injection site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferdi Gülaştı

Aydin, 09020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute PainPain, Postoperative

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Blind patients and postoperative follow-ups will not know which group the patient is in the study
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized double blinding
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiologist

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 22, 2024

Study Start

January 1, 2024

Primary Completion

February 26, 2025

Study Completion

February 26, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations