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

24 september 2018 uppdaterad av: Raghu Thota, Tata Memorial Hospital

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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)

EXCLUSION CRITERIA:

  1. presence of preoperative shoulder pain,
  2. preoperative shoulder pathology,
  3. use of analgesics for more than 1 week preoperatively,
  4. inability to understand the numeric rating scale(NRS)scoring system for pain assessment
  5. failure to extubate at the end of surgery.
  6. Patients who haven't given consent
  7. Age < 18yrs and > 75 yrs.

STATISTICAL ANALYSIS:

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.

Studietyp

Observationell

Inskrivning (Faktisk)

370

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Maharashtra
      • Mumbai, Maharashtra, Indien, 400025
        • Tata Memorial Centre

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Prevalence of Ipsilateral shoulder pain
Tidsram: Upto 12 hours post surgery
Numeric rating scale within 12 hours post operative
Upto 12 hours post surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Raghu S Thota, MD, Tata Memorial Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 augusti 2017

Primärt slutförande (Faktisk)

21 augusti 2018

Avslutad studie (Faktisk)

21 augusti 2018

Studieregistreringsdatum

Först inskickad

10 augusti 2017

Först inskickad som uppfyllde QC-kriterierna

13 augusti 2017

Första postat (Faktisk)

15 augusti 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 september 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 september 2018

Senast verifierad

1 september 2018

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 1900

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

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