- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367581
Costotransverse Foramen Block Versus Thoracic Paravertebral Block in Thoracotomy for Lung Cancer
Costotransverse Foramen Block Versus Thoracic Paravertebral Block in Thoracotomy for Lung Cancer: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Thoracotomy is known to be one of the most painful surgeries. Managing post-thoracotomy pain is a major clinical challenge, as about 75% of patients report moderate to severe pain afterward.
Various regional and central analgesia techniques, such as thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), and erector spinae plane block (ESPB), are employed in a multimodal approach. Although TEA has traditionally been considered the gold standard for thoracotomy pain control, concerns about its side effects have prompted the exploration of alternatives.
The costotransverse foramen block (CTFB), a recently introduced technique, has been examined in both cadaveric and case studies.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mai M Elrawas, MD
- Phone Number: 00201222177242
- Email: mai.elrawas@nci.cu.edu.eg
Study Locations
-
-
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Cairo, Egypt, 12613
- Recruiting
- Cairo University
-
Contact:
- Mai M Elrawas, MD
- Phone Number: 00201222177242
- Email: mai.elrawas@nci.cu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years and ≤ 65 years old.
- American Society of Anesthesiologists (ASA) physical status II-III.
- Body mass index 18-35 kg/m2.
- Patients scheduled for thoracotomies for lung cancer.
Exclusion Criteria:
- Patient refusal.
- History of sensitivity to local anesthetics.
- History of psychological disorders.
- Contraindication to regional anesthesia, e.g., local sepsis, pre-existing peripheral neuropathies, and coagulopathy.
- Severe respiratory, cardiac, hepatic, or renal disease.
- Morbid obesity.
- Uncooperative patients.
- Patients on chronic pain therapy.
Study Plan
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 |
|---|---|
|
Experimental: CTFB Group
Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.
|
Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.
|
|
Experimental: TPVB Group
Patients will receive an ipsilateral ultrasound-guided thoracic paravertebral plane block with injection of 20 ml bupivacaine 0.25%.
|
Patients will receive an ipsilateral ultrasound-guided thoracic paravertebral plane block with injection of 20 ml bupivacaine 0.25%.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
If the visual analog scale (VAS) is ≥ 4, rescue analgesics will be administered in the form of a 4 mg bolus of morphine.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative fentanyl consumption
Time Frame: Intraoperatively
|
Intraoperative fentanyl consumption will be recorded.
|
Intraoperatively
|
|
Duration of analgesia
Time Frame: 24 hours postoperatively
|
Duration of analgesia will be recorded from the end of surgery till first dose of morphine administrated.
|
24 hours postoperatively
|
|
Degree of pain
Time Frame: 48 hours postoperatively
|
Each patient will be instructed about postoperative pain assessment with the visual analog scale (VAS).
VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
VAS will be recorded in post-anesthesia care unit (PACU) and after 1, 6, 12, 24 & 48 hours postoperatively
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48 hours postoperatively
|
|
Mean arterial blood pressure
Time Frame: 4 hours postoperatively
|
Mean arterial blood pressure will be recorded before induction of general anesthesia to be defined as the baseline reading.
Another reading will be noted immediately before surgical incision and at 20-minute intervals intraoperatively, and then hourly for the next 4 hours postoperatively.
|
4 hours postoperatively
|
|
Heart rate
Time Frame: 4 hours postoperatively
|
Heart rate will be recorded before induction of general anesthesia to be defined as the baseline reading.
Another reading will be noted immediately before surgical incision and at 20-minute intervals intraoperatively, and then hourly for the next 4 hours postoperatively.
|
4 hours postoperatively
|
|
Incidence of block-related side effects
Time Frame: 4 hours postoperatively
|
Incidence of block-related side effects such as unexpected epidural anesthesia, pneumothorax, total spinal anesthesia, or local anesthetic intoxication will be recorded.
|
4 hours postoperatively
|
|
Incidence of side effects
Time Frame: 4 hours postoperatively
|
Incidence of side effects such as postoperative nausea and vomiting, drowsiness, or dyspnea will be recorded.
|
4 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AP2512-501-141-205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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