Cairo University
Cairo, 12613, Egypt
Location status: Recruiting
NCT Number: NCT07424638
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.
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Request Info18 year–65 year
All sexes
Interventional
Not applicable
Cairo, 12613, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive an ultrasound-guided interscalene block.
Patients will receive an ultrasound-guided anterior suprascapular block.
Patients will not receive regional blocks apart from epidural analgesia.
Time frame: 72 hours postoperatively
Frequency of occurrence of ipsilateral shoulder pain will be recorded.
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.
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.
Time frame: 48 hours postoperatively
Heart rate will be recorded every 30 minutes and immediately postoperative then every 4 h postoperative for 48 h.
Time frame: 72 hours postoperatively
Incidence of postoperative complications will be recorded.
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).
Time frame: 72 hours postoperatively
Total number of rescue analgesia will be recorded.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
National Cancer Institute, Egypt
Other
Interscalene Block Versus Anterior Suprascapular Block for Post-Thoracotomy Shoulder Pain: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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