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Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery

Primary Purpose

Erector Spinae Block

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector spinae Block
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erector Spinae Block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 68 patients
  • ASA I-III,
  • Aged 18-75 years
  • underwent lumbar spine surgery under elective conditions

Exclusion Criteria:

  • Presence of contraindications to LA agents used in this study
  • Use of chronic opioids,
  • Psychiatric disorders.
  • Surgical procedures that lasted <60 minutes or> 300 minutes
  • The presence of infection at the injection area.

Sites / Locations

  • Adnan Menderes UnivesityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Block group

control group

Arm Description

Outcomes

Primary Outcome Measures

NRS(numerical rating scala)
Each item is scored 0-10 ( 0=no pain, 10= pain as bad as can be) Postoperative pain intensity reported with NRS score : 30. minute, 1. hours, 6. hours, 12. hours, 24. hours
pruritus, nausea and vomiting, use of antiemetics
each criterion is reported as present or absent each criterion is reported as present or absent
mobilized , discharged
each criterion is reported as when the patient is mobilized and when he is discharged

Secondary Outcome Measures

Full Information

First Posted
May 27, 2019
Last Updated
June 26, 2019
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT03997227
Brief Title
Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery
Official Title
Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery : A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
May 2, 2020 (Anticipated)
Study Completion Date
July 2, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

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
Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay. The aim of this study was to investigate the effect of this field block on postoperative pain and respiratory function in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia.
Detailed Description
Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay. The aim of this study was to investigate the effect of this field block on postoperative pain and respiratory function in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia. ASA I-III, 68 patients between 18-75 years of age were planned to be included in the study. 34 participants were expected to be included in the control and implementation group. In our study, the ESP block was planned to be applied to the patients in the block group. Peroperative analgesia plan will be applied to all patients in the same way. In this protocol, intravenous paracetamol 1 gr and tramadol 1 mg / kg were determined. Then, every eight hours, paracetamol and contromal infusion. At the end of the operation, the patients will be determined by the Numeric Rating Scale (NRS) system at the 30th hour, 1st, 6th, 12th and 24th hours after the first hour of the operation. Tramadol PCA and paracetamol are administered every eight hours. Age, sex, weight, body mass index, application of ESP block, time of surgery, duration of surgery, evaluation of pain in postoperative recovery room and 24-hour follow-up will be recorded when the patient is mobilized and discharged. It is thought that the ESP block will decrease postoperative pain by providing effective pain control after surgery in patients undergoing lumbar vertebra surgery. In addition, it is thought to accelerate mobilization in the postoperative period and shorten the time of discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erector Spinae Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Block group
Arm Type
Active Comparator
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Erector spinae Block
Intervention Description
After anesthesia and surgical procedures, a bilateral ESP block with ultrasound guidance will be applied from the T10 level at the middle line 3 cm lateral. Prior to the block, with povidone iodine, the T10 transverse protrusion will be determined by using linear ultrasound probe. The local anesthetic will be applied between the transverse projection and the erector spina muscle with the help of an isolated needle designed for peripheral block operations. Without local anesthesia, the location of the needle with saline will be confirmed by hydrodissection. After confirming the location of the needle, 20 ml of LA and saline mixture will be applied and the same procedure will be repeated in the control. A total of 40 ml of LA, 20 ml of bupivacaine 0.5%, 10 ml of lidocaine 2%, 10 ml of saline will be composed of saline.
Primary Outcome Measure Information:
Title
NRS(numerical rating scala)
Description
Each item is scored 0-10 ( 0=no pain, 10= pain as bad as can be) Postoperative pain intensity reported with NRS score : 30. minute, 1. hours, 6. hours, 12. hours, 24. hours
Time Frame
24 hours
Title
pruritus, nausea and vomiting, use of antiemetics
Description
each criterion is reported as present or absent each criterion is reported as present or absent
Time Frame
24 hours
Title
mobilized , discharged
Description
each criterion is reported as when the patient is mobilized and when he is discharged
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 68 patients ASA I-III, Aged 18-75 years underwent lumbar spine surgery under elective conditions Exclusion Criteria: Presence of contraindications to LA agents used in this study Use of chronic opioids, Psychiatric disorders. Surgical procedures that lasted <60 minutes or> 300 minutes The presence of infection at the injection area.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sinan Asar
Phone
905556316560
Email
s.asar@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinem Sarı
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adnan Menderes Univesity
City
Aydın
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selda Şen
Email
drseldasen@yahoo.com
First Name & Middle Initial & Last Name & Degree
Sinem Sarı
First Name & Middle Initial & Last Name & Degree
Sinan Asar

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30758122
Citation
Almeida CR, Oliveira AR, Cunha P. Continuous Bilateral Erector of Spine Plane Block at T8 for Extensive Lumbar Spine Fusion Surgery: Case Report. Pain Pract. 2019 Jun;19(5):536-540. doi: 10.1111/papr.12774. Epub 2019 Mar 15.
Results Reference
result

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Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery

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