- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05300854
Serratus Block Versus Paravertebral Block for Post Thoracotomy Pain Relief
March 28, 2022 updated by: Eman Ibraheem Darweesh, Sohag University
Serratus Anterior Plane Block Versus Paravertebral Plane Block for Post Thoracotomy Pain Relief: A Comparative Study
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sohag, Egypt
- Faculty of Medicine, Sohag University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard anesthesia in addition to serratus plane block
general anesthesia was given then ultrasound-guided serratus plane block
|
a US-guided SPB was performed after induction of general anesthesia with the patient lying supine.
|
Active Comparator: Standard anesthesia in addition to para-vertebral block
general anesthesia was given then ultrasound-guided para-vertebral block
|
Standard anesthesia in addition to para-vertebral block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevention of post-operative pain
Time Frame: 72 hours
|
reduction of visual analogue score
|
72 hours
|
reduction of analgesic requirement
Time Frame: 72 hours
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
March 19, 2022
First Submitted That Met QC Criteria
March 28, 2022
First Posted (Actual)
March 29, 2022
Study Record Updates
Last Update Posted (Actual)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh-Med-22-2-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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