- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424638
Interscalene Block Versus Anterior Suprascapular Block for Post-Thoracotomy Shoulder Pain
Interscalene Block Versus Anterior Suprascapular Block for Post-Thoracotomy Shoulder Pain: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Thoracotomy is one type of surgery associated with challenging pain that needs to be promptly addressed to avoid post-operative respiratory complications and aid in effective postoperative physiotherapy and patient recovery. Epidural analgesia is considered the gold standard for the thoracotomy procedure. Ipsilateral shoulder pain (ISP) following thoracotomy has an incidence ranging from 37% to 85%.
Being so common, this pain needs more attention and proper anticipation, and management. ISP is usually non-responsive to the effects of epidural and paravertebral blocks.
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 who have a confirmed diagnosis of lung cancer and are scheduled for elective open-lung surgery.
Exclusion Criteria:
- Allergy to local anesthetics.
- Known psychiatric or neurologic disorders.
- Alcohol or narcotics abuse.
- Contraindications to thoracic epidural or suprascapular block, or interscalene block, e.g., coagulopathy or local infection.
- Pre-existing shoulder symptoms.
- History of previous thoracotomy.
- Severe restrictive or obstructive pulmonary disease.
- Pre-existing contralateral diaphragmatic paralysis.
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: Group (I)
Patients will receive an ultrasound-guided interscalene block.
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Patients will receive an ultrasound-guided interscalene block.
|
|
Experimental: Group (S)
Patients will receive an ultrasound-guided anterior suprascapular block.
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Patients will receive an ultrasound-guided anterior suprascapular block.
|
|
Active Comparator: Group (E)
Patients will not receive regional blocks apart from epidural analgesia.
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Patients will not receive regional blocks apart from epidural analgesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of occurrence of ipsilateral shoulder pain
Time Frame: 72 hours postoperatively
|
Frequency of occurrence of ipsilateral shoulder pain will be recorded.
|
72 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of pain
Time Frame: 72 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 after intensive care unit (ICU) admission then every 6 h postoperative for 72 h.
|
72 hours postoperatively
|
|
Mean arterial pressure
Time Frame: 48 hours postoperatively
|
Mean arterial pressure will be recorded every 30 minutes and immediately postoperative then every 4 h postoperative for 48 h.
|
48 hours postoperatively
|
|
Heart rate
Time Frame: 48 hours postoperatively
|
Heart rate will be recorded every 30 minutes and immediately postoperative then every 4 h postoperative for 48 h.
|
48 hours postoperatively
|
|
Incidence of complications
Time Frame: 72 hours postoperatively
|
Incidence of postoperative complications will be recorded.
|
72 hours postoperatively
|
|
Time to first request of rescue analgesia
Time Frame: 72 hours postoperatively
|
Rescue analgesia with 5 ml of 0.25% bupivacaine through the epidural catheter (in case of thoracotomy pain).
Ketorolac 30 mg I.V. over 50 cc saline for breakthrough shoulder pain (will not exceed 120 mg/day).
|
72 hours postoperatively
|
|
Total number of rescue analgesia
Time Frame: 72 hours postoperatively
|
Total number of rescue analgesia will be recorded.
|
72 hours postoperatively
|
|
Peak Expiratory Flow Rate
Time Frame: 72 hours postoperatively
|
Peak Expiratory Flow Rate (PEFR) will be recorded as baseline in holding area before premedication and every 6 h postoperative for 72 h when visual analog scale (VAS) is ≤ 3.
|
72 hours postoperatively
|
|
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 72 hours postoperatively
|
Forced Expiratory Volume in 1 second (FEV1) will be recorded preoperative and at day 0, 1, 2 & 3 when visual analog scale (VAS) is ≤ 3.
|
72 hours postoperatively
|
|
Forced vital capacity (FVC)
Time Frame: 72 hours postoperatively
|
Forced vital capacity (FVC) will be recorded preoperative and at day 0, 1, 2 & 3 when visual analog scale (VAS) is ≤ 3.
|
72 hours postoperatively
|
|
Forced Expiratory Volume in 1 second (FEV1) / Forced vital capacity (FVC) ratio
Time Frame: 72 hours postoperatively
|
Forced Expiratory Volume in 1 second (FEV1) / Forced vital capacity (FVC) ratio will be recorded preoperative and at day 0, 1, 2 & 3 when visual analog scale (VAS) is ≤ 3.
|
72 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
- AP2512-501-152-202
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
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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