Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | May 2014 |
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.
(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.
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.
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.
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
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