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Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery (SCPB)

Primary Purpose

Shoulder Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Superficial Cervical Plexus Block
Bupivacaine
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Superficial Cervical Plexus Block, Thoracic Surgery, Thoracotomy, Video-Assisted Thoracoscopic Surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subjects who clinically consented to elective thoracotomy or video-assisted thoracoscopic surgery (VATS) under general anesthesia and epidural analgesia
  • ages between 18 and 75 years

Exclusion Criteria:

  • inability to perform thoracic epidural
  • violation of protocol (e.g., administration of medication that does not comply with the study protocol)
  • subject has change of mind
  • surgery has to be repeated

Non-inclusion Criteria:

  • subject refusal
  • non-English speaking
  • previous chronic or neuropathic pain
  • previous chronic use of opioids
  • history of psychiatric disorder
  • allergy to local anesthetic
  • previous ipsilateral thoracotomy or VATS
  • prior history of shoulder pain

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Controls

Superficial Cervical Plexus Block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain

Secondary Outcome Measures

Post-operative Opioid Consumption Expressed in Morphine Equivalents
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
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
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
Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension

Full Information

First Posted
March 1, 2012
Last Updated
June 14, 2017
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT01550302
Brief Title
Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery
Acronym
SCPB
Official Title
The Effect of Superficial Cervical Plexus Block on Post-Thoracotomy/Scopy Ipsilateral Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Unable to continue enrollment due to lack of resources (research coordinator no longer available).
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 0.25% bupivacaine under the skin. Regardless of whether the subject gets an injection or not, he/she 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 subject's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Superficial Cervical Plexus Block, Thoracic Surgery, Thoracotomy, Video-Assisted Thoracoscopic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controls
Arm Type
No Intervention
Arm Description
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.
Arm Title
Superficial Cervical Plexus Block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Superficial Cervical Plexus Block
Other Intervention Name(s)
Cervical Plexus Block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcain, Marcaine, Sensorcaine and Vivacaine
Intervention Description
Single dose of 37.5 mg of bupivacaine subcutaneously
Primary Outcome Measure Information:
Title
Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain
Time Frame
24 hours after lung surgery
Secondary Outcome Measure Information:
Title
Post-operative Opioid Consumption Expressed in Morphine Equivalents
Time Frame
24 hours after the surgery
Title
Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement
Description
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
Time Frame
6, 12, 18, 24 and 48 hours after the surgery
Title
Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing
Description
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
Time Frame
6, 12, 18, 24 and 48 hours after the surgery
Title
Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing
Description
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
Time Frame
6, 12, 18, 24 and 48 hours after the surgery
Title
Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication
Time Frame
48 hours after the surgery
Title
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension
Time Frame
24 and 48 hours after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects who clinically consented to elective thoracotomy or video-assisted thoracoscopic surgery (VATS) under general anesthesia and epidural analgesia ages between 18 and 75 years Exclusion Criteria: inability to perform thoracic epidural violation of protocol (e.g., administration of medication that does not comply with the study protocol) subject has change of mind surgery has to be repeated Non-inclusion Criteria: subject refusal non-English speaking previous chronic or neuropathic pain previous chronic use of opioids history of psychiatric disorder allergy to local anesthetic previous ipsilateral thoracotomy or VATS prior history of shoulder pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srdjan Jelacic, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18195603
Citation
MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67.
Results Reference
background
PubMed Identifier
8439033
Citation
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.
Results Reference
background
PubMed Identifier
14570798
Citation
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.
Results Reference
background

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Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery

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