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

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Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status

Completed

Conditions

Postoperative Pain
Spine Fracture
Spine Deformity
Spine Injury
Spine Malformation

Treatments

Procedure: superficial erector spina plane block
Procedure: Standard (opioid-based) analgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT05244031
2021-271

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups

Superficial ESP
Active Comparator group
Description:
The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia
Treatment:
Procedure: superficial erector spina plane block
Control group
Active Comparator group
Description:
The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia
Treatment:
Procedure: Standard (opioid-based) analgesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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