Study of Prevalence of Ipsilateral Shoulder Pain in Patients After Thoracic Surgeries

NCT03249766 | Completed DMC

• 1 other identifier: 1900
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

Thoracic surgeries are associated with significant operative trauma1. While thoracic epidural analgesia may help control the incisional component of the pain, an excruciating postthoracotomy. Ipsilateral Shoulder Pain (ISP) could under mine pain management in the post thoracotomy patient2. The incidence of ISP ranges from 21% to 97%3. ISP impairs respiration, mobility, and physical therapy in the early postoperative period4. The etiology of ISP is unclear. Several hypotheses have been proposed as possible causes of ISP, including transection of a major bronchus, ligament distraction by surgical retraction, shoulder joint strain as a result of intraoperative positioning, pleural irritation due to the thoracostomy tube, and referred pain from irritation of the pericardium or mediastinal and diaphragmatic surfaces2, 5, 6. ISP is defined as the pain occurring on the operated side of thoracic surgeries in the immediate postoperative period as early as one hour after surgery6,of dull aching, stabbing, burning, electric or throbbing nature of moderate to severe intensity and resistant to treatment, most commonly located in the region of the deltoid muscle or on the posterior or superior surface of the arm or above ⅓ of the lateral part of the clavicle on the anterior surface of the chest, lasting 3-4 days2, 7-11.The primary objective of this study is to find out the prevalence of ISP and the risk factors associated with it.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Prevalence of Ipsilateral shoulder pain

  Numeric rating scale within 12 hours post operative

  Upto 12 hours post surgery

Interventions

Observational OTHER

Observational study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. 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.

You may qualify if:

• All male \& female patients (aged 18-75 years) who undergo thoracic surgeries where the pleura is opened including Video Assisted Thoracic Surgeries (VATS)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 400025, India

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Raghu S Thota, MD

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 15, 2017
• Study Start: August 22, 2017
• Primary Completion: August 21, 2018
• Study Completion: August 21, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

IN (1)