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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05244031
• Other study ID #: 2021-271
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: February 7, 2022

Study information

• Verified date: February 2022
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 7, 2022
• Est. primary completion date: February 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Spinal Fractures
• Spine Deformity
• Spine Fracture
• Spine Injury

Intervention

Procedure:
• superficial erector spina plane block
The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia
• Standard (opioid-based) analgesia
The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr. Sadi Konuk Research and Training Hospital	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS scores of patients	NRS at 1, 6,12, 18, 24, 36, 48th hours	48 hours postoperatively
Secondary	Postoperative 48-hours total morphine consumption	This will be measured only one time by pca device at the 48th hour after surgery.	48 hours postoperatively