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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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. 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.
Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain
Measured: 24 hours after lung surgery
Secondary outcomes (6)
Post-operative Opioid Consumption Expressed in Morphine Equivalents
Measured: 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
Measured: 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
Measured: 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
Measured: 6, 12, 18, 24 and 48 hours after the surgery
Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication
Measured: 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
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.
- First posted9 Mar 2012 (estimated)
- Study startOct 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Unable to continue enrollment due to lack of resources (research coordinator no longer available).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srdjan Jelacic, University of Washington
- Investigators
- Srdjan Jelacic, MD, Principal investigator, University of Washington
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 18195603Burgess 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 8439033Pandit 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Superficial Cervical Plexus Block on Post-Thoracotomy/Scopy Ipsilateral Shoulder Pain
- ClinicalTrials.gov ID
- NCT01550302
- Acronym / sponsor ID
- SCPB / 42272
- Conditions
- Shoulder Pain
- Keywords
- Superficial Cervical Plexus Block, Thoracic Surgery, Thoracotomy, Video-Assisted Thoracoscopic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to continue enrollment due to lack of resources (research coordinator no longer available).
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Posted 4 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Superficial Cervical Plexus Block, Drug: BupivacaineSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- 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
- subject refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superficial Cervical Plexus BlockAlso: Cervical Plexus BlockAt 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. | Procedure or surgery | Superficial Cervical Plexus Block |
| BupivacaineAlso: Marcain, Marcaine, Sensorcaine and VivacaineSingle dose of 37.5 mg of bupivacaine subcutaneously | Drug | Superficial Cervical Plexus Block |
Primary outcome
Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain
Time frame: 24 hours after lung surgery
6 secondary outcomes
Post-operative Opioid Consumption Expressed in Morphine Equivalents
Time frame: 24 hours after the surgery
Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement
Time frame: 6, 12, 18, 24 and 48 hours after the surgery
Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing
Time frame: 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
Time frame: 6, 12, 18, 24 and 48 hours after the surgery
Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication
Time frame: 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
Time frame: 24 and 48 hours after the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18195603MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67.
- Background: PubMed 8439033Burgess 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.
- Background: PubMed 14570798Pandit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srdjan Jelacic, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
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.