Study of Prevalence of Ipsilateral Shoulder Pain in Patients After Thoracic Surgeries
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|ClinicalTrials.gov Identifier: NCT03249766|
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : September 25, 2018
|Condition or disease||Intervention/treatment|
|Lung Cancer||Other: Observational|
This will be a prospective observational study, which will be done over a period of one year (Upto 250 patients) after approval from ethics committee. The data of the first three months will be analysed (Upto 60 patients) and will presented as a thesis for MD (Anaesthesia). It will be carried out at Tata Memorial Centre, Mumbai. After Institutional Ethics Committee approval, Written informed consent in the language the patient understands the best will be obtained undergoing thoracic surgeries where the pleura is opened including Thoracotomy, Video Assisted Thoracic Surgeries (VATS). Data over a three months period will be collected. Pain at the incisional site and Ipsilateral shoulder pain (ISP) will be assessed separately using the numeric rating scale (NRS) during the patients' stay in the postanesthesia care unit (PACU) by an independent assessor, at 1 hour, 6 hours and 12 hours after coming to the PACU. The characteristics, intensity and pain at shoulder at rest and movement will also be assessed. Data including age, sex, BMI, American Society of Anesthesiologists (ASA) physical status, diagnosis, side and type of operation, surgical approach, positioning during surgery, duration of surgery, type of regional anesthesia, and, in patients with epidural anesthesia, level of catheter placement will also be recorded.
All male & female patients (aged 18-75 years) who undergo thoracic surgeries where the pleura is opened including Video Assisted Thoracic Surgeries (VATS)
- presence of preoperative shoulder pain,
- preoperative shoulder pathology,
- use of analgesics for more than 1 week preoperatively,
- inability to understand the numeric rating scale(NRS)scoring system for pain assessment
- failure to extubate at the end of surgery.
- Patients who haven't given consent
- Age < 18yrs and > 75 yrs.
Since the study will be done over a period of twelve months, there is no sample size.
Continuous variables will be analyzed using independent t-test or Mann Whitney U test as per the distribution of the data for continuous variables. Categorical variables will be analyzed using Chi-square test or Fisher's exact test. P-value < 0.05 will be considered statistical significant. Risk factors of ISP will be analyzed using univariate and multivariate binary regression with robust estimates to calculate odds ratio (OR) and their 95% confidence interval. A manual stepwise forward logistic regression will be used to extract univariate independent variables. A p value ≤ 0.2 by univariate analysis will be used as the criterion for choosing variables to be included in the model for multivariate analysis. A p value <0.05 is considered statistically significant. Cut-off points of the independent variables, including age group and duration of surgery, are estimated by the method of maximum likelihood to achieve best discrimination between patients with and without ISP.
|Study Type :||Observational|
|Actual Enrollment :||370 participants|
|Official Title:||Prospective Observational Study of Prevalence of Ipsilateral Shoulder Pain in Patients After Thoracic Surgeries|
|Actual Study Start Date :||August 22, 2017|
|Actual Primary Completion Date :||August 21, 2018|
|Actual Study Completion Date :||August 21, 2018|
- Other: Observational
- Prevalence of Ipsilateral shoulder pain [ Time Frame: Upto 12 hours post surgery ]Numeric rating scale within 12 hours post operative
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249766
|Tata Memorial Centre|
|Mumbai, Maharashtra, India, 400025|
|Principal Investigator:||Raghu S Thota, MD||Tata Memorial Hospital|