- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06831578
Compare the Perioperative Analgesic Effect of Ultrasound Guided Thoracic Paravertebral Block and Ultrasound Guided Serratus Anterior Block in Patients Undergoing Thoracotomy (thoracotomy)
February 15, 2025 updated by: Asmaa Mohamed Hamza Sedky, Menoufia University
Analgesic Efficacy of Ultrasound-guided Serratus Anterior Plane Block Versus Thoracic Paravertebral Plane Block in Patients Undergoing Thoracotomy
The aim of this study is to compare the perioperative analgesic effect of ultrasound guided thoracic paravertebral block and ultrasound guided serratus anterior block in patients undergoing thoracotomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
randomized, comparative study General anesthesia will be conducted
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
- Phase 3
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
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Shebin elkom, Egypt
- Menoufia faculty of medicine hospital
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Menoufia
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Shebeen elkom, Menoufia, Egypt
- Menoufia University Hospital
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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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- : Patients 20 to 60 years old
- ASA physical status of class II and III.
Exclusion Criteria:
Patients with severe respiratory disease
- preexisting neurologic deficit
- allergy to any of the study drug
- kypho-scoliosis
- presence of local infection
- on current chronic analgesic therapy, having history of opioid dependence'
- patient refusal
- inablity to communicate with the investigators
- who will require postoperative mechanical ventilation .
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: serratus anterior plane block
|
after patient consenting, induction of anathesia Under sterile conditions, and while the patients will be still on the lateral position with the diseased side up after induction of anesthesia, a linear ultrasound transducer (10-12 MHz) will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage.
Then counting down ribs till the seventh rib will be identified in the mid-axillar]y line.
The following muscles will be identified overlying the sixth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior).
The needle (22-G, 50-mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane deep to the serratus anterior muscle .
Under continuous ultrasound guidance, 20 ml of 0.25% bupivacaine will be injected then a catheter will be threaded.
A continuous infusion of 5 ml/hr of 0.125% bupivacaine will be then started through the catheter.
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Active Comparator: paravertebral plane block
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after concenting patient, induction of anathesia Paravertebral plan block will be performed while the patient is still in lateral position and a linear ultrasound transducer (10-12 MHz) will be used for ultrasound guidance.
A sagittal or transverse image can be obtained at the appropriate vertebral level.
After image optimization, the Tuohy needle is advanced in plane until the tip rests in the thoracic paravertebral space.
Injection of small amounts of fluid (hydrodissection) will aid in needle tip location.
Saline or local anesthetic is injected through the Tuohy needle.
The endpoint for a successful block is anterior displacement of the pleura.
20 ml of 0.25% bupivacaine will be injected then a catheter will be threaded.
A continuous infusion of 5 ml/hr of 0.125% bupivacaine will be then started through the catheter.
The catheter is threaded through the Tuohy needle and its position is confirmed by injecting local anesthetic or small air bubbles.
Pleural depression should agai
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain
Time Frame: postoperative up to 24 hours
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with the use of the visual analouge scale (VAS) in the preoperative visit.
Where 0 score as no pain and 10 as the worst imaginable pain.
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postoperative up to 24 hours
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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)
December 10, 2023
Primary Completion (Actual)
February 10, 2025
Study Completion (Actual)
February 10, 2025
Study Registration Dates
First Submitted
February 9, 2025
First Submitted That Met QC Criteria
February 15, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 15, 2025
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10/2024 ANESTH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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