Back to resultsErector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Erector spinae plane block
sham subcutaneous infiltration
Sponsored by
About this trial
This is an interventional other trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists class I-III adult patients
- BMI less than or equal 35 kg/m2
Exclusion Criteria:
- Patient refusal
- unable to give consent
- age < 18 or > 65
- BMI more than 35 kg/m2
- known allergy to the study medication
- coagulopathies or on anticoagulant medications
- hepatic insufficiency
- renal insufficiency
- chronic opioid use
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Erector block
sham block
Arm Description
Outcomes
Primary Outcome Measures
Analgesia
Numerical rating scale of pain every 6 hours
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04749095
Brief Title
Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery
Official Title
Can Bilateral Erector Spinae Plane Block Minimize Perioprative Opioid Consumption and Provide Satisfactory Analgesia for Lumbar Spine Fusion Surgery? A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lumbar spine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Erector block
Arm Type
Active Comparator
Arm Title
sham block
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Erector spinae plane block
Intervention Description
bilateral ESP block will be injected with 20 ml of 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
sham subcutaneous infiltration
Intervention Description
bilateral ESP block will be injected with 20 ml of normal saline
Primary Outcome Measure Information:
Title
Analgesia
Description
Numerical rating scale of pain every 6 hours
Time Frame
Up to 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists class I-III adult patients
BMI less than or equal 35 kg/m2
Exclusion Criteria:
Patient refusal
unable to give consent
age < 18 or > 65
BMI more than 35 kg/m2
known allergy to the study medication
coagulopathies or on anticoagulant medications
hepatic insufficiency
renal insufficiency
chronic opioid use
12. IPD Sharing Statement
Learn more about this trial
Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery
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