Anterior Suprascapular Block, Interscalene Block, Shoulder Pain, Thoracotomy
Conditions
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.
Interventions
OTHERInterscalene block
Patients will receive an ultrasound-guided interscalene block.
Patients will receive an ultrasound-guided anterior suprascapular block.
OTHEREpidural analgesia
Patients will not receive regional blocks apart from epidural analgesia.
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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/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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of occurrence of ipsilateral shoulder pain | 72 hours postoperatively | Frequency of occurrence of ipsilateral shoulder pain will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in 1 second (FEV1) | 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. |
| Incidence of complications | 72 hours postoperatively | Incidence of postoperative complications will be recorded. |
| Time to first request of rescue analgesia | 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). |
| Total number of rescue analgesia | 72 hours postoperatively | Total number of rescue analgesia will be recorded. |
| Degree of pain | 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. |
| Mean arterial pressure | 48 hours postoperatively | Mean arterial pressure will be recorded every 30 minutes and immediately postoperative then every 4 h postoperative for 48 h. |
| Heart rate | 48 hours postoperatively | Heart rate will be recorded every 30 minutes and immediately postoperative then every 4 h postoperative for 48 h. |
| Forced vital capacity (FVC) | 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. |
| Peak Expiratory Flow Rate | 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. |
| Forced Expiratory Volume in 1 second (FEV1) / Forced vital capacity (FVC) ratio | 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. |
Countries
Egypt
Contacts
CONTACTMai M Elrawas, MD
Outcome results
None listed