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

Intraoperative Placement of Superficial Erector Spinae Plane Block in Spine Surgery; An Effective Approach at Enhanced Recovery After Spine Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05244031
Enrollment
46
Registered
2022-02-17
Start date
2021-05-10
Completion date
2022-02-07
Last updated
2022-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Spine Deformity, Spine Fracture, Spine Injury, Spine Malformation

Keywords

Postoperative pain, Superficial Erector Spinae Plane Block, Spine Surgery, Local anesthetic

Brief 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.

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.

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

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Ages of 18-65 * Patients who will undergo spine surgery (at least two level) * ASA I-II-III patients

Exclusion criteria

* Clinically known local anesthetic allergy * Morbid obesity (body mass index\>40 kg m2) * Clinically diagnosis of opioid, alcohol and substance dependence * Clinically diagnosis of psychiatric disease * Coagulopathy * Patients with ASA IV-V * Single level surgery

Design outcomes

Primary

MeasureTime frameDescription
NRS scores of patients48 hours postoperativelyNRS at 1, 6,12, 18, 24, 36, 48th hours

Secondary

MeasureTime frameDescription
Postoperative 48-hours total morphine consumption48 hours postoperativelyThis will be measured only one time by pca device at the 48th hour after surgery.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026