Back to resultsComparison Between the Analgesic Efficacy of Erector Spinae Plane Block and Psoas Compartment Block in Hip Surgery
Primary Purpose
Hip Arthropathy
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Psoas Compartment Block Group (GROUP I)
Erector Spinae Plane block ( Group II)
Control Group (GROUP III)
Sponsored by
About this trial
This is an interventional treatment trial for Hip Arthropathy focused on measuring Erector spinae block, hip arthroplasty, postoperative analgesia, psoas compartment block, ultrasound
Eligibility Criteria
Inclusion Criteria:
ASA (American Society of Anesthesiologists) I- ASA II Patients
-
Exclusion Criteria:
- history of allergy to the study medication
- refusal to participate
Sites / Locations
- Sibel Seçkin Pehlivan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Psoas compartment block group (PCB)
Erector spinae plane block group (ESP)
The Control group
Arm Description
Single- shot ultrasound (Esaote Mylab30) guided PCB with 15 ml 0.25% bupivacain ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the PCB group (Group I).
Single- shot ultrasound (Esaote Mylab30) guided ESP block with 15 ml 0.25% ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the ESP group (Group II).
The Control group receive no intervention ( 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 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Verbal analog Pain Scores on rest and movement
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 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 vomiting)
incidences of nausea and vomiting during the 24 hours postoperative period will recorded at 6 time intervals ( 2, 4, 6, 12, 24 hours).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03904095
Brief Title
Comparison Between the Analgesic Efficacy of Erector Spinae Plane Block and Psoas Compartment Block in Hip Surgery
Official Title
Comparison Between the Analgesic Efficacy of Erector Spinae Plane Block and Psoas Compartment Block in Hip Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (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 Psoas compartment block to decrease postoperative pain and analgesia requirements in patients undergoing hip surgery.
Detailed Description
Erector spina Plane block or Psoas compartment block will performed with guided ultrasound at L4 Transverse process level would lead to adequate postoperative analgesia ,in total hip arthroplasty surgeries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy
Keywords
Erector spinae block, hip arthroplasty, postoperative analgesia, psoas compartment block, ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients randomly allocated to three treatment groups: , The psoas compartment block (Group I) the ESP block group (Group II) and the control group (Group III). Blocks performed after general anesthesia induction with the Ultrasound while patients lying on surgical type at the top.
Masking
ParticipantInvestigator
Masking Description
participant care provider
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psoas compartment block group (PCB)
Arm Type
Active Comparator
Arm Description
Single- shot ultrasound (Esaote Mylab30) guided PCB with 15 ml 0.25% bupivacain ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the PCB group (Group I).
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% ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the ESP group (Group II).
Arm Title
The Control group
Arm Type
Placebo Comparator
Arm Description
The Control group receive no intervention ( Group III).
Intervention Type
Procedure
Intervention Name(s)
Psoas Compartment Block Group (GROUP I)
Intervention Description
Psoas Compartment Block will perform preoperative to all patients in Group I. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane block ( Group II)
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)
Control Group (GROUP III)
Intervention Description
Control group will receive no intervention. 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 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Time Frame
24 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 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
incidences of adverse effects (like nausea and vomiting)
Description
incidences of nausea and vomiting during the 24 hours postoperative period will recorded at 6 time intervals ( 2, 4, 6, 12, 24 hours).
Time Frame
24 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 (American Society of Anesthesiologists) 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
Sibel Pehlivan
Organizational Affiliation
TC Erciyes University
Official's Role
Study Director
Facility Information:
Facility Name
Sibel Seçkin Pehlivan
City
Kayseri
State/Province
Talas
ZIP/Postal Code
38039
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 12 months of study completion
IPD Sharing Access Criteria
Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
18945717
Citation
Touray ST, de Leeuw MA, Zuurmond WW, Perez RS. Psoas compartment block for lower extremity surgery: a meta-analysis. Br J Anaesth. 2008 Dec;101(6):750-60. doi: 10.1093/bja/aen298. Epub 2008 Oct 22.
Results Reference
result
PubMed Identifier
30292068
Citation
Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
Results Reference
result
PubMed Identifier
30443064
Citation
Tulgar S, Ermis MN, Ozer Z. Combination of lumbar erector spinae plane block and transmuscular quadratus lumborum block for surgical anaesthesia in hemiarthroplasty for femoral neck fracture. Indian J Anaesth. 2018 Oct;62(10):802-805. doi: 10.4103/ija.IJA_230_18.
Results Reference
result
Links:
URL
http://doi.org/10.1016/j.jclinane.2018.06.033
Description
Related Info
Learn more about this trial
Comparison Between the Analgesic Efficacy of Erector Spinae Plane Block and Psoas Compartment Block in Hip Surgery
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