ClinicalTrials.gg
CompletedNCT05244031Updated Mar 3, 2022

Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery

An interventional study of superficial erector spina plane block and Standard (opioid-based) analgesia in Postoperative Pain, Spine Deformity and Spine Injury, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled May 2021, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Major spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study is to compare the effect of ultrasound (US)-guided superficial erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia.

Read the detailed description

46 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo spine surgery, were randomized and divided into two groups. (23 patients in each of the control and superficial ESP groups). Superficial ESP block was performed for SESP group and standard (opioid-based) analgesia performed in the control group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative numeric rating scale values were the primary outcome measure. 24-hour total morphine consumption was secondary outcome measure.

02

Conditions studied

  • Postoperative Pain
  • Spine Deformity
  • Spine Injury
  • Spine Fracture
  • Spine Malformation

Keywords

  • Postoperative pain
  • Superficial Erector Spinae Plane Block
  • Spine Surgery
  • Local anesthetic
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's enrollment of 46 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 122 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ages of 18-65
  • Patients who will undergo spine surgery (at least two level)
  • -III patients

Exclusion criteria

Exclusion Criteria:

  • Clinically known local anesthetic allergy
  • Morbid obesity (>40 kg m2)
  • Clinically diagnosis of opioid, alcohol and substance dependence
  • Clinically diagnosis of psychiatric disease
  • Coagulopathy
  • Patients with
  • Single level surgery
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    Superficial ESP

    The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia

    Procedure: superficial erector spina plane block

  • Active comparator
    Control group

    The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia

    Procedure: Standard (opioid-based) analgesia

Interventions

  • Proceduresuperficial erector spina plane block

    The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia

  • ProcedureStandard (opioid-based) analgesia

    The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia

06

What researchers measure

Primary outcomes

  1. NRS scores of patients

    NRS at 1, 6,12, 18, 24, 36, 48th hours

    Time frame: 48 hours postoperatively

Secondary outcomes

  1. Postoperative 48-hours total morphine consumption

    This will be measured only one time by pca device at the 48th hour after surgery.

    Time frame: 48 hours postoperatively

07

Study locations

1 site
  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital
    Istanbul, Bakirkoy 34147, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05244031
Responsible party
Gokhan Sertcakacilar, MD (Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital) — Principal investigator
First posted
Feb 17, 2022
Start date
May 10, 2021
Primary completion
Feb 7, 2022
Completion
Feb 7, 2022
Last update
Mar 3, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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