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

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05244031

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Spine Deformity Spine Injury Spine Fracture Spine Malformation	Procedure: superficial erector spina plane block Procedure: Standard (opioid-based) analgesia	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 10, 2021

Actual Primary Completion Date :

Feb 7, 2022

Actual Study Completion Date :

Feb 7, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Superficial ESP

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

Procedure: superficial erector spina plane block

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

Active Comparator: Control group

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

Procedure: Standard (opioid-based) analgesia

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bakirkoy Dr. Sadi Konuk Research and Training Hospital	Istanbul	Bakirkoy	Turkey	34147

Sponsors and Collaborators

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gokhan Sertcakacilar, MD, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

ClinicalTrials.gov Identifier:

NCT05244031

Other Study ID Numbers:

2021-271

First Posted:

Feb 17, 2022

Last Update Posted:

Mar 3, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gokhan Sertcakacilar, MD, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Postoperative pain

Superficial Erector Spinae Plane Block

Spine Surgery

Local anesthetic

Additional relevant MeSH terms:

Pain, Postoperative

Spinal Fractures

Analgesics, Opioid

Study Results

No Results Posted as of Mar 3, 2022