Ignite Creation Date:
2024-05-06 @ 12:22 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01550302
Status:
TERMINATED
Last Update Posted:
2017-07-18
First Post:
2012-03-01
Brief Title:
Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
The Effect of Superficial Cervical Plexus Block on Post-ThoracotomyScopy Ipsilateral Shoulder Pain
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to continue enrollment due to lack of resources research coordinator no longer available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCPB
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
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
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
Intra-operative block an injection of bupivacaine on the side of the neck at the end of the surgery while the subject is still under general anesthesia or no injection at all if in control group If the subject is assigned to receive an injection the investigators will be using a small needle similar to the one used to numb the skin for the IV start There will be a single needle stick on the side of the neck same side as the lung surgery and injection of 15 mL of 025 bupivacaine under the skin Regardless of whether the subject gets an injection or not heshe will receive standard clinical care
Post-lung surgery pain assessment the investigators will ask the subjects to rate their pain at the incision site chest tube site and shoulder at rest and with movement at 6 12 18 24 and 48 hours after lung surgery The investigators will also ask the subjects about any side-effects that may be associated with the standard narcotic pain medications
The investigators will collect the following data from the medical record including
Presence or absence of shoulder pain
The amount of pain medicines narcotics needed to treat subjects pain over 24 and 48 hours after lung surgery
The presence of any side-effects of narcotic pain medications
Blood pressure heart rate EKG and oxygen levels when available in order to evaluate if improved shoulder pain and less narcotics used will have additional beneficial effects
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
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
Intra-operative block an injection of bupivacaine on the side of the neck at the end of the surgery while the subject is still under general anesthesia or no injection at all if in control group If the subject is assigned to receive an injection the investigators will be using a small needle similar to the one used to numb the skin for the IV start There will be a single needle stick on the side of the neck same side as the lung surgery and injection of 15 mL of 025 bupivacaine under the skin Regardless of whether the subject gets an injection or not heshe will receive standard clinical care
Post-lung surgery pain assessment the investigators will ask the subjects to rate their pain at the incision site chest tube site and shoulder at rest and with movement at 6 12 18 24 and 48 hours after lung surgery The investigators will also ask the subjects about any side-effects that may be associated with the standard narcotic pain medications
The investigators will collect the following data from the medical record including
Presence or absence of shoulder pain
The amount of pain medicines narcotics needed to treat subjects pain over 24 and 48 hours after lung surgery
The presence of any side-effects of narcotic pain medications
Blood pressure heart rate EKG and oxygen levels when available in order to evaluate if improved shoulder pain and less narcotics used will have additional beneficial effects
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None