Comparison of muscle sparing thoracotomy and posterolateral thoracotomy for pulmonary lobectomy for lung cancer

Completed

Conditions: ung cancer
Cancer
Malignant neoplasm of the lung

Registration Number: ISRCTN17868937

Lead Sponsor: Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Male and female
2. Aged greater than 18 and less than 80 years
3. Lung cancer (stage I and II)
4. Informed consent

Exclusion Criteria

1. Previous thoracic surgery
2. Psychiatric disease
3. Non-controlled diabetes
4. Thoracic wall resection
5. Epidural analgesia
6. Severe cardiovascular or pulmonary disease
7. Drug abuse
8. Chronic pain syndromes

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pain severity, assessed by patients 4 times a day in a relaxed position, and during coughing using a visual analogue pain scale (0 = no pain, 10 = most severe pain). The eight scores were then averaged to produce a daily composite score. Pain scores were measured pre-operatively and daily after surgery to post-operative day 7. After 1, 3, 6, 12 months and 3 years following the operation, patients were asked about the occurrence of symptoms of post-thoracotomy pain or post-thoracotomy syndrome.<br>2. Analgesic consumption for pain at the site of the thoracotomy was recorded. An aggregate analgesic score (AAS) was computed adding 1 point for each mg of intravenous morphine used, 5 points for every dose of intravenous ketorolac (30 mg) and 4 points for each oral dose of acetaminophen-codeine (500/30 mg) administered.

Secondary Outcome Measures

Name	Time	Method
1. Shoulder mobility and muscle strength was measured by a physiotherapist before surgery; the analyses were repeated at 1, 3 and 7 post-operative days and after 1 and 6 months by the same blinded observer. Muscle strength was recorded during adduction, abduction, flexion and extension on the operated side; the results were graded on a scale from 0 to 5 (5 = normal strength) according to the Daniels and Worthingham's muscle tests<br>2. Pulmonary function tests were obtained pre-operatively and daily after surgery to post-operative day 7. The spirometry was repeated at 1, 3, 6, 12 months and 3 years after the operation.<br>3. Major morbidity