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Unable to continue enrollment due to lack of resources (research coordinator no longer available).
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | No Intervention | Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment. | |
| Superficial Cervical Plexus Block | Active Comparator | Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superficial Cervical Plexus Block | Procedure | At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a "fan" technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain | 24 hours after lung surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Opioid Consumption Expressed in Morphine Equivalents | 24 hours after the surgery | |
| Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement | Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants |
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Inclusion Criteria:
Exclusion Criteria:
Non-inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srdjan Jelacic, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18195603 | Background | MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67. | |
| 8439033 | Background | Burgess FW, Anderson DM, Colonna D, Sborov MJ, Cavanaugh DG. Ipsilateral shoulder pain following thoracic surgery. Anesthesiology. 1993 Feb;78(2):365-8. doi: 10.1097/00000542-199302000-00023. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Controls | Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment. |
| FG001 | Superficial Cervical Plexus Block | Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia. Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a "fan" technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site. Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Controls | Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain | Posted | Count of Participants | Participants | 24 hours after lung surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Controls | Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Srdjan Jelacic | University of Washington | (206) 598-3777 | sjelacic@uw.edu |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D066008 | Cervical Plexus Block |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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|
|
| Bupivacaine | Drug | Single dose of 37.5 mg of bupivacaine subcutaneously |
|
|
| 6, 12, 18, 24 and 48 hours after the surgery |
| Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing | Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants | 6, 12, 18, 24 and 48 hours after the surgery |
| Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing | Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants | 6, 12, 18, 24 and 48 hours after the surgery |
| Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication | 48 hours after the surgery |
| Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension | 24 and 48 hours after the surgery |
| 14570798 | Background | Pandit JJ, Dutta D, Morris JF. Spread of injectate with superficial cervical plexus block in humans: an anatomical study. Br J Anaesth. 2003 Nov;91(5):733-5. doi: 10.1093/bja/aeg250. |
| BG001 | Superficial Cervical Plexus Block | Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia. Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a "fan" technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site. Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Duration of Surgery | Mean | Standard Deviation | minutes |
|
|
|
| Secondary | Post-operative Opioid Consumption Expressed in Morphine Equivalents | Posted | Mean | Standard Deviation | mg | 24 hours after the surgery |
|
|
|
| Secondary | Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement | Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants | Data not collected for 6, 12, and 18 hours at rest or with movement/coughing | Posted | Mean | Standard Deviation | units on a scale | 6, 12, 18, 24 and 48 hours after the surgery |
|
|
|
| Secondary | Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing | Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants | Data not collected for 6, 12, and 18 hours at rest or moving/with cough | Posted | Mean | Standard Deviation | units on a scale | 6, 12, 18, 24 and 48 hours after the surgery |
|
|
|
| Secondary | Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing | Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants | Data not collected for 6, 12, and 18 hours at rest or with movement/cough | Posted | Mean | Standard Deviation | units on a scale | 6, 12, 18, 24 and 48 hours after the surgery |
|
|
|
| Secondary | Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication | Posted | Number | number of participants | 48 hours after the surgery |
|
|
|
| Secondary | Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension | Hypotension data not collected | Posted | Count of Participants | Participants | 24 and 48 hours after the surgery |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Superficial Cervical Plexus Block | Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia. Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a "fan" technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site. Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously | 0 | 5 | 0 | 5 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| At rest 12 hrs |
|
| Movement or cough 12 hrs |
|
| At rest 18 hrs |
|
| Movement or cough 18 hrs |
|
| At rest 24 hrs |
|
|
| With movement 24 hrs |
|
|
| At rest 48 hrs |
|
|
| With movement 48 hrs |
|
|
| At rest 12 hrs |
|
| Movement or cough 12 hrs |
|
| At rest 18 hrs |
|
| Movement or cough 18 hrs |
|
| At rest 24 hrs |
|
|
| Movement or cough 24 hrs |
|
|
| At rest 48 hrs |
|
|
| Movement or cough 48 hrs |
|
|
| At rest 12 hrs |
|
| Movement or cough 12 hrs |
|
| At rest 18 hrs |
|
| Movement or cough 18 hrs |
|
| At rest 24 hrs |
|
|
| Movement or cough 24 hrs |
|
|
| At rest 48 hrs |
|
|
| Movement or cough 48 hrs |
|
|
| PONV 48 hrs |
|
|
| Pruritis 24 hrs |
|
|
| Pruritis 48 hrs |
|
|
| Dizziness 24 hrs |
|
|
| Dizziness 48 hrs |
|
|
| Sedation 24 hrs |
|
|
| Sedation 48 hrs |
|
|
| Respiratory Depression 24 hrs |
|
|
| Respiratory Depression 48 hrs |
|
|
| Hypotension 24 hrs |
|
| Hypotension 48 hrs |
|