Clinical trial NCT01550302: Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery
Official title: The Effect of Superficial Cervical Plexus Block on Post-Thoracotomy/Scopy Ipsilateral Shoulder Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Shoulder Pain
Keywords: Superficial Cervical Plexus Block
Thoracic Surgery
Thoracotomy
Video-Assisted Thoracoscopic Surgery
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain
timeFrame: 24 hours after lung surgery
Secondary outcomes:
measure: Post-operative Opioid Consumption Expressed in Morphine Equivalents
timeFrame: 24 hours after the surgery
measure: Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement
timeFrame: 6, 12, 18, 24 and 48 hours after the surgery
measure: Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing
timeFrame: 6, 12, 18, 24 and 48 hours after the surgery
measure: Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing
timeFrame: 6, 12, 18, 24 and 48 hours after the surgery
measure: Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication
timeFrame: 48 hours after the surgery
measure: Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension
timeFrame: 24 and 48 hours after the surgery
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Srdjan Jelacic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67.
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.
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.