Back to resultsComparison of Postoperative Analgesic Consumption of the Erector Spina Plane Block and Serratus Anterior Plane Block
Primary Purpose
Thoracic Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane block ( Group ı)
Serratus Anterior Plane block ( Group ıı)
Control Group (GROUPIII)
Sponsored by
About this trial
This is an interventional treatment trial for Thoracic Diseases focused on measuring dispne, pain
Eligibility Criteria
Inclusion Criteria:
ASA I- ASA II Patients
Exclusion Criteria:
- history of allergy to the study medication
- refusal to participate
Sites / Locations
- Ayşe Ülgey
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Erector spinae plane block group (ESP)
Serratus Anterior Plane Block Group (SAP)
Control Group
Arm Description
Single- shot ultrasound (Esaote Mylab30) guided ESP block with 15 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4 vertebral level will performed preoperatively to patients in the ESP group (Group I).
Single- shot ultrasound (Esaote Mylab30 )guided SAP block with 15 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) the T4 vertebral level will performed preoperatively to patients in the SAP group( Group II).
The Control group receive no intervetion ( Group III).
Outcomes
Primary Outcome Measures
opioid consumption
In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 6 mg 1 h limit.Total morphine consumption during the 48 hours postoperative period will recorded at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours).
Verbal analog Pain Scores on rest and movement
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours) in the 48 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
Secondary Outcome Measures
Incidences of adverse effects (like nausea and vomitting)
Incidences of nausea and vomitting during the 48 hours postoperative period will recorded at 6 time intervals (2,4,6,12,24,48. hours)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03904082
Brief Title
Comparison of Postoperative Analgesic Consumption of the Erector Spina Plane Block and Serratus Anterior Plane Block
Official Title
Evaluation of the Efficiency of Erector Spina Plane Block and Serratus Anterior Plane Block for Postoperative Thorasic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes 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
To evaluate the ability of Erector spina Plane block and Serratus Anterior Plane block to decrease postoperative pain and analgesia requirements in patients undergoing thoracotomy.
Detailed Description
Thoracic wall nerve blocks such as Erector spina Plane block and Serratus Anterior Plane block have become popular for preoperative pain control in patients undergoing thoracotomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Diseases
Keywords
dispne, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Erector spinae plane block group (ESP)
Arm Type
Active Comparator
Arm Description
Single- shot ultrasound (Esaote Mylab30) guided ESP block with 15 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4 vertebral level will performed preoperatively to patients in the ESP group (Group I).
Arm Title
Serratus Anterior Plane Block Group (SAP)
Arm Type
Active Comparator
Arm Description
Single- shot ultrasound (Esaote Mylab30 )guided SAP block with 15 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) the T4 vertebral level will performed preoperatively to patients in the SAP group( Group II).
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The Control group receive no intervetion ( Group III).
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane block ( Group ı)
Intervention Description
ESP Block will perform preoperative to all patients in ESP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
Intervention Type
Procedure
Intervention Name(s)
Serratus Anterior Plane block ( Group ıı)
Intervention Description
SAP Block will perform preoperative to all patients in SAP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
Intervention Type
Procedure
Intervention Name(s)
Control Group (GROUPIII)
Intervention Description
Control group will receive no intervetion. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
Primary Outcome Measure Information:
Title
opioid consumption
Description
In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 6 mg 1 h limit.Total morphine consumption during the 48 hours postoperative period will recorded at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours).
Time Frame
48 hours after surgery
Title
Verbal analog Pain Scores on rest and movement
Description
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours) in the 48 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
Incidences of adverse effects (like nausea and vomitting)
Description
Incidences of nausea and vomitting during the 48 hours postoperative period will recorded at 6 time intervals (2,4,6,12,24,48. hours)
Time Frame
48 hours after surgery
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- ASA II Patients
Exclusion Criteria:
history of allergy to the study medication
refusal to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşe Ülgey, MD
Organizational Affiliation
TC Erciyes University
Official's Role
Study Director
Facility Information:
Facility Name
Ayşe Ülgey
City
Kayseri
State/Province
Talas
ZIP/Postal Code
38100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identifed individual participant data for all primary and secondary outcome measures will be made aailable.
IPD Sharing Time Frame
Data will be aailable within 10 months of study completion.
IPD Sharing Access Criteria
Data accep requests will be rewiewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
29980005
Citation
Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
Results Reference
background
PubMed Identifier
28188621
Citation
Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
Results Reference
background
PubMed Identifier
29149734
Citation
Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. No abstract available.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://doi.org/10.1016/j.jclinane.2018.06.033
Learn more about this trial
Comparison of Postoperative Analgesic Consumption of the Erector Spina Plane Block and Serratus Anterior Plane Block
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