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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2022-02-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain Spine Deformity Spine Injury Spine Fracture Spine Malformation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Superficial ESP

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

Group Type ACTIVE_COMPARATOR

superficial erector spina plane block

Intervention Type PROCEDURE

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

Control group

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

Group Type ACTIVE_COMPARATOR

Standard (opioid-based) analgesia

Intervention Type PROCEDURE

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

Interventions

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superficial erector spina plane block

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

Intervention Type PROCEDURE

Standard (opioid-based) analgesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No