- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04264689
Perioperative Thoracotomy Analgesia; Different Analgesic Modalities
December 3, 2020 updated by: Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
the study aim is to compare the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
comparing the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries regarding pain control and possible side effects
Study Type
Interventional
Enrollment (Actual)
51
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
-
-
-
Cairo, Egypt, 11796
- Department of anesthesia and pain medicine. National Cancer Institute
-
-
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 to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients scheduled for thoracotomy age 18-65
Exclusion Criteria:
- patient refusal coagulation defects abnormal kidney or liver functions local infection at site of block bone metastases
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: thoracic epidural
thoracic epidural will be done before induction of general anesthesia
|
thoracic epidural
|
EXPERIMENTAL: serratus anterior block
ultrasound guided serratus anterior block will be done after induction of general anesthesia
|
ultrasound guided block
|
EXPERIMENTAL: erector spinae block
ultrasound guided erector spinae block will be done after induction of general anesthesia
|
ultrasound guided block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analogue score
Time Frame: 24 hours
|
minimum value 0 and maximum value 10
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mean arterial blood pressure
Time Frame: 24 hours
|
measurement of mean arterial blood pressure
|
24 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)
March 2, 2020
Primary Completion (ACTUAL)
October 28, 2020
Study Completion (ACTUAL)
November 3, 2020
Study Registration Dates
First Submitted
February 9, 2020
First Submitted That Met QC Criteria
February 10, 2020
First Posted (ACTUAL)
February 11, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 7, 2020
Last Update Submitted That Met QC Criteria
December 3, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AP1906-50105
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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