Back to resultsSerratus Block Versus Paravertebral Block for Post Thoracotomy Pain Relief
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Standard anesthesia in addition to serratus plane block
Standard anesthesia in addition to para-vertebral block
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
- patients more than 18 ys undergoing thoracotomy operation
Exclusion Criteria:
- morbid obesity (Body mass index > 40)
- impossibility of anatomical structures US identification in a satisfactory way
- opioids treatment before surgery or substance abuse,
- sepsis and/or infection at the puncture sites
Sites / Locations
- Faculty of Medicine, Sohag University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard anesthesia in addition to serratus plane block
Standard anesthesia in addition to para-vertebral block
Arm Description
general anesthesia was given then ultrasound-guided serratus plane block
general anesthesia was given then ultrasound-guided para-vertebral block
Outcomes
Primary Outcome Measures
prevention of post-operative pain
reduction of visual analogue score
reduction of analgesic requirement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05300854
Brief Title
Serratus Block Versus Paravertebral Block for Post Thoracotomy Pain Relief
Official Title
Serratus Anterior Plane Block Versus Paravertebral Plane Block for Post Thoracotomy Pain Relief: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag 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
This double-blinded, randomized controlled study was done on 60 patients older than 18 years undergoing thoracotomy. Patients were allocated into two equal groups (30 patients each). Group S: Standard anesthesia in addition to SPB. II. Group P: Standard anesthesia in addition to PVB.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard anesthesia in addition to serratus plane block
Arm Type
Active Comparator
Arm Description
general anesthesia was given then ultrasound-guided serratus plane block
Arm Title
Standard anesthesia in addition to para-vertebral block
Arm Type
Active Comparator
Arm Description
general anesthesia was given then ultrasound-guided para-vertebral block
Intervention Type
Procedure
Intervention Name(s)
Standard anesthesia in addition to serratus plane block
Intervention Description
a US-guided SPB was performed after induction of general anesthesia with the patient lying supine.
Intervention Type
Procedure
Intervention Name(s)
Standard anesthesia in addition to para-vertebral block
Intervention Description
Standard anesthesia in addition to para-vertebral block
Primary Outcome Measure Information:
Title
prevention of post-operative pain
Description
reduction of visual analogue score
Time Frame
72 hours
Title
reduction of analgesic requirement
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients more than 18 ys undergoing thoracotomy operation
Exclusion Criteria:
morbid obesity (Body mass index > 40)
impossibility of anatomical structures US identification in a satisfactory way
opioids treatment before surgery or substance abuse,
sepsis and/or infection at the puncture sites
Facility Information:
Facility Name
Faculty of Medicine, Sohag University
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Serratus Block Versus Paravertebral Block for Post Thoracotomy Pain Relief
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