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

This study is currently recruiting participants.
Verified December 2013 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Srdjan Jelacic, University of Washington
ClinicalTrials.gov Identifier:
NCT01550302
First received: March 1, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Shoulder Pain
Procedure: Superficial Cervical Plexus Block
Drug: Bupivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Superficial Cervical Plexus Block on Post-Thoracotomy/Scopy Ipsilateral Shoulder Pain

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Incidence of post-thoracotomy/scopy ipsilateral shoulder pain [ Time Frame: 24 and 48 hours after lung surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative opioid consumption expressed in morphine equivalents [ Time Frame: 24 and 48 hours after the surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate the need for post-operative ibuprofen as a rescue medication [ Time Frame: 48 hours after the surgery ] [ Designated as safety issue: No ]
  • Evaluate 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Active Comparator: 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.
Procedure: 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.
Other Name: Cervical Plexus Block
Drug: Bupivacaine
Single dose of 37.5 mg of bupivacaine subcutaneously
Other Name: Marcain, Marcaine, Sensorcaine and Vivacaine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subjects who clinically consented to elective thoracotomy or VATS procedure 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550302

Contacts
Contact: Srdjan Jelacic, MD (206) 598-3777 sjelacic@uw.edu
Contact: Philippe Richebe, MD PhD (206) 616-3348 prichebe@uw.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: Srdjan Jelacic, MD         
Sub-Investigator: Thomas A Bowdle, MD PhD         
Sub-Investigator: Philippe Richebe, MD PhD         
Sub-Investigator: Douglas E Wood, MD         
Sub-Investigator: Michael S Mulligan, MD         
Sub-Investigator: Aaron M Cheng, MD         
Sub-Investigator: Kei Togashi, MD         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Srdjan Jelacic, MD University of Washington
  More Information

Publications:
Responsible Party: Srdjan Jelacic, Acting Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01550302     History of Changes
Other Study ID Numbers: 42272-D
Study First Received: March 1, 2012
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Superficial Cervical Plexus Block
Thoracic Surgery
Thoracotomy
Video-Assisted Thoracoscopic Surgery

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014