Back to resultsErector Spinae Plane Block For Lumbar Disc Hernia Repair
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane block
Sham block
Bupivacaine Hydrochloride
PCA
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Lomber disc hernia, Erector spinae plane block, Postoperative pain
Eligibility Criteria
Inclusion Criteria:
- ASA I-II
- Age 18-65 years
- Undergoing elective lomber disc hernia
Exclusion Criteria:
- obesity
- ASA III - IV
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
Sites / Locations
- Kocaeli University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Erector Spinae Plane Block
Control Group
Arm Description
Erector Spinae Plane Block Group Block Drug: 0,25% bupivacaine hydrochloride (20ml) will be used for blocks
Sham block will be done with serum physiologic.
Outcomes
Primary Outcome Measures
Morphine consumption
morphine consumptions will be recorded
Secondary Outcome Measures
Numeric rating scale
Numeric rating scale for pain will be used for pain evaluation. The scale is scored in a range of 0-10 with 0 representing no pain 10 representing the highest degree of pain.
Full Information
NCT ID
NCT03744689
First Posted
November 15, 2018
Last Updated
February 4, 2020
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT03744689
Brief Title
Erector Spinae Plane Block For Lumbar Disc Hernia Repair
Official Title
The Effect Of Erector Spinae Plane Block On Postoperative Pain Management In Lumbar Disc Hernia Repair Operation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pain management after lomber disc hernia repair surgery is a challenging issue for anesthetists. Erector Spinae plane block is a novel analgesic technique which could be used for this purpose. Primary aim of this double blinded randomized controlled study is to compare the analgesic efficacy of this new block technique with control group in this group of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Lomber disc hernia, Erector spinae plane block, Postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Description
Erector Spinae Plane Block Group
Block Drug: 0,25% bupivacaine hydrochloride (20ml) will be used for blocks
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Sham block will be done with serum physiologic.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane block
Intervention Description
Erector Spinae plane block will be done according to hernia level using bupivacaine hydrochloride
Intervention Type
Procedure
Intervention Name(s)
Sham block
Intervention Description
Sham block will be done with serum physiologic.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
20 ml 0,25% Bupivacaine will be used for block performances
Intervention Type
Device
Intervention Name(s)
PCA
Intervention Description
Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
Primary Outcome Measure Information:
Title
Morphine consumption
Description
morphine consumptions will be recorded
Time Frame
postoperative first 24 hour
Secondary Outcome Measure Information:
Title
Numeric rating scale
Description
Numeric rating scale for pain will be used for pain evaluation. The scale is scored in a range of 0-10 with 0 representing no pain 10 representing the highest degree of pain.
Time Frame
postoperative first 24 hour
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:
ASA I-II
Age 18-65 years
Undergoing elective lomber disc hernia
Exclusion Criteria:
obesity
ASA III - IV
infection of the skin at the site of needle puncture area
patients with known allergies to any of the study drugs
coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Icli
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
33751203
Citation
Yorukoglu HU, Icli D, Aksu C, Cesur S, Kus A, Gurkan Y. Erector spinae block for postoperative pain management in lumbar disc hernia repair. J Anesth. 2021 Jun;35(3):420-425. doi: 10.1007/s00540-021-02920-0. Epub 2021 Mar 22.
Results Reference
derived
Learn more about this trial
Erector Spinae Plane Block For Lumbar Disc Hernia Repair
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