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Shoulder PainPhase 4SCPBNCT01550302

Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery

A Phase 4 study testing Superficial Cervical Plexus Block and Bupivacaine in people with Shoulder Pain, run by University of Washington at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Shoulder Pain
What is being tested?
Superficial Cervical Plexus Block and Bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Oct 2013to May 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: The Effect of Superficial Cervical Plexus Block on Post-Thoracotomy/Scopy Ipsilateral Shoulder Pain

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.

Read the 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.

Conditions
Shoulder Pain
Being tested
Superficial Cervical Plexus Block, Bupivacaine
Keywords
Superficial Cervical Plexus Block, Thoracic Surgery, Thoracotomy, Video-Assisted Thoracoscopic Surgery
Medical subject headings
Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Superficial Cervical Plexus BlockProcedure or surgery

    Also called 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.

  • BupivacaineDrug

    Also called Marcain, Marcaine, Sensorcaine and Vivacaine

    Single dose of 37.5 mg of bupivacaine subcutaneously

Study groups in NCT01550302
Study groupRoleWhat they receive
ControlsNo interventionSubjects 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 BlockActive comparatorSubjects 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.
Receives: Procedure: Superficial Cervical Plexus Block; Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain

    Measured: 24 hours after lung surgery

Secondary outcomes (6)
  1. Post-operative Opioid Consumption Expressed in Morphine Equivalents

    Measured: 24 hours after the surgery

  2. 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

    Measured: 6, 12, 18, 24 and 48 hours after the surgery

  3. 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

    Measured: 6, 12, 18, 24 and 48 hours after the surgery

  4. 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

    Measured: 6, 12, 18, 24 and 48 hours after the surgery

  5. Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication

    Measured: 48 hours after the surgery

  6. Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension

    Measured: 24 and 48 hours after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2012 (estimated)
  2. Study startOct 2013
  3. Primary completionMay 2014
  4. Study completionMay 2014

Why it stopped: Unable to continue enrollment due to lack of resources (research coordinator no longer available).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01550302
Sponsor's protocol ID
42272
Acronym
SCPB
Status last verified
Jun 2017
First submitted
1 Mar 2012
Last updated
18 Jul 2017
Data monitoring committee
Yes

Publications

  • MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67.

    PubMed 18195603
  • 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.

    PubMed 8439033
  • 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.

    PubMed 14570798

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Superficial Cervical Plexus Block and Bupivacaine in people with Shoulder Pain, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain (time frame: 24 hours after lung surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01550302, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.

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