Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery (SCPB)
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| First Received Date ICMJE | March 1, 2012 | ||||||||
| Last Updated Date | June 12, 2012 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Incidence of post-thoracotomy/scopy ipsilateral shoulder pain [ Time Frame: 24 and 48 hours after lung surgery ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01550302 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery | ||||||||
| Official Title ICMJE | The Effect of Superficial Cervical Plexus Block on Post-Thoracotomy/Scopy Ipsilateral Shoulder Pain | ||||||||
| Brief Summary | The investigators want to know whether injecting numbing medication on the side of the neck (also called superficial cervical plexus block) can prevent or reduce shoulder pain that patients commonly experience after lung surgery. The investigators will perform the injection at the end of your surgery while the subjects are still under general anesthesia and before they wake up. The investigators will use a local anesthetic (bupivacaine or Marcaine®) that is routinely used for skin infiltration of the surgical wounds. This study is randomized and single-blind. This means that subjects will be assigned by chance (like flipping a coin) to receive either an injection with active medication (bupivacaine), or no injection at all. |
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| Detailed Description | Pain management following lung surgery is of outmost importance. Providing adequate pain control facilitates patient recovery and improves lung function, therefore, leading to reduced morbidity and mortality associated with lung surgery. It is now well-established that lung surgery is associated with significant incisional pain, which in some patients may lead to development of chronic post-thoracotomy pain syndrome. In addition, many patients report significant shoulder pain that is often resistant to increasing epidural infusions and intravenous opioid therapy. The incidence of shoulder pain varies from study to study with estimates anywhere between 41% to 97%. Although the cause of the shoulder pain is not well understood, there are only few therapies available for the treatment of shoulder pain including acetaminophen, non-steroidal anti-inflammatory drugs, interscalene brachial plexus and stellate ganglion block. However, all of the currently available therapies have potentially significant side-effects. The investigators are not aware of any studies evaluating the effectiveness of superficial cervical plexus block in reducing or preventing shoulder pain following thoracotomy or thoracoscopic surgery. The superficial cervical plexus block is minimal risk procedure equivalent to an IV start. The primary aim of this study is to compare the effect of superficial cervical plexus block when added to thoracic epidural analgesia and intravenous patient controlled analgesia (PCA) to standard thoracic epidural analgesia and PCA used at our institution on the incidence of shoulder pain. Subjects participating in this study will receive standard clinical care in addition to the following research procedures:
The investigators will collect the following data from the medical record including:
Subjects are eligible if they are age 18-75 years and undergoing lung surgery. Subjects are not eligible if they are non-English speaking, have had a previous lung surgery, are allergic to bupivacaine, have a history of chronic pain or have been taking pain medications for a long time, and already have shoulder pain. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Shoulder Pain | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 70 | ||||||||
| Estimated Completion Date | July 2013 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Non-inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01550302 | ||||||||
| Other Study ID Numbers ICMJE | 42272-D | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Srdjan Jelacic, University of Washington | ||||||||
| Study Sponsor ICMJE | University of Washington | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Washington | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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