Interscalene Block Versus Anterior Suprascapular Block for Post-Thoracotomy Shoulder Pain: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Frequency of occurrence of ipsilateral shoulder pain
Study Overview
Brief Summary
This study aims to compare the frequency of occurrence of ipsilateral shoulder pain in patients undergoing thoracotomy with ultrasound-guided interscalene block, anterior suprascapular block as adjunct to epidural and epidural block only.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years and ≤ 65 years old.
- •American Society of Anesthesiologists (ASA) physical status II-III.
- •Body mass index 18-35 kg/m
- •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.
Arms & Interventions
Group (I)
Patients will receive an ultrasound-guided interscalene block.
Intervention: Interscalene block (Other)
Group (S)
Patients will receive an ultrasound-guided anterior suprascapular block.
Intervention: Anterior suprascapular block (Other)
Group (E)
Patients will not receive regional blocks apart from epidural analgesia.
Intervention: Epidural analgesia (Other)
Outcomes
Primary Outcomes
Frequency of occurrence of ipsilateral shoulder pain
Time Frame: 72 hours postoperatively
Frequency of occurrence of ipsilateral shoulder pain will be recorded.
Secondary Outcomes
- Degree of pain(72 hours postoperatively)
- Mean arterial pressure(48 hours postoperatively)
- Heart rate(48 hours postoperatively)
- Incidence of complications(72 hours postoperatively)
- Time to first request of rescue analgesia(72 hours postoperatively)
- Total number of rescue analgesia(72 hours postoperatively)
- Peak Expiratory Flow Rate(72 hours postoperatively)
- Forced Expiratory Volume in 1 second (FEV1)(72 hours postoperatively)
- Forced vital capacity (FVC)(72 hours postoperatively)
- Forced Expiratory Volume in 1 second (FEV1) / Forced vital capacity (FVC) ratio(72 hours postoperatively)
Investigators
Mai Mohamed El Rawas
Assistant professor of Anaesthesia, Intensive Care and Pain Management, National Cancer Institute, Cairo University Cairo University, Cairo, Egypt.
National Cancer Institute, Egypt