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

Primary Purpose

Postoperative Pain, Spine Deformity, Spine Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
superficial erector spina plane block
Standard (opioid-based) analgesia
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Postoperative pain, Superficial Erector Spinae Plane Block, Spine Surgery, Local anesthetic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Superficial ESP

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative 48-hours total morphine consumption
This will be measured only one time by pca device at the 48th hour after surgery.

Full Information

First Posted
February 8, 2022
Last Updated
February 16, 2022
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05244031
Brief Title
Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery
Official Title
Intraoperative Placement of Superficial Erector Spinae Plane Block in Spine Surgery; An Effective Approach at Enhanced Recovery After Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
February 7, 2022 (Actual)
Study Completion Date
February 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Spine Deformity, Spine Injury, Spine Fracture, Spine Malformation
Keywords
Postoperative pain, Superficial Erector Spinae Plane Block, Spine Surgery, Local anesthetic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Superficial ESP
Arm Type
Active Comparator
Arm Description
The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
superficial erector spina plane block
Intervention Description
The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
Standard (opioid-based) analgesia
Intervention Description
The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia
Primary Outcome Measure Information:
Title
NRS scores of patients
Description
NRS at 1, 6,12, 18, 24, 36, 48th hours
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Postoperative 48-hours total morphine consumption
Description
This will be measured only one time by pca device at the 48th hour after surgery.
Time Frame
48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey

12. IPD Sharing Statement

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

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