Clinical trial NCT03210181: Superficial Cervical Plexus Block for Neck and Shoulder Pain
Official title: Superficial Cervical Plexus Block for Neck and Shoulder Pain Due to Levator Scapulae Syndrome: a Randomized, Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Shoulder Pain
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Myofascial pain is an important cause of neck pain or neck and shoulder pain. Neck shoulder pain is a common socioeconomic problem that negatively affects the quality of life. Different treatment strategies with limited effectiveness or application have been implemented. However, medication remains a widely used approach.

The levator scapulae is one of the muscles involved in myofascial pain leading to levator scapulae syndrome. The muscle limits the rotation of the neck. It is innervated by branches of the third and fourth cervical nerves through the cervical plexus. Hence, performing superficial cervical plexus block may have some potential effect in reducing myofascial pain.

Detailed description: Patients are randomly divided into two equal groups using the computer-based sealed envelope technique. Group I (Block) will receive superficial cervical plexus block and group II (Placebo) will receive placebo. The physician, patient and data collector are all blind to the patients' assigned group.

Demographic data including gender, age, BMI and American Society of Anesthesiologists (ASA) physical status will be noted at the initial visit. Moreover, patients' medical history, pain history, characteristics and type of pain, as well as previous treatment are collected for each patient. In addition, side effects, pain scores and analgesic consumption will be recorded after performing the block.

Patients will receive 14 daily charts to record daily pain scores, symptoms and the use of analgesics. Patients will be told to take their medications as usual. They will be contacted via phone calls to ensure that they are recording information in the charts.

Pain is assessed using the visual analogue scale (VAS). Patients with score \<4 are given 500 mg paracetamol with a maximum of 6 tables per day, or ketoprofen 100 mg tablet to a maximum of 3 tables per 24 hours. Patients with a score\>4 are given tramadol hydrochloride 100 mg tablet to a maximum of 3 tablets per day.

Superficial cervical plexus block technique A nerve stimulator is used to guide the superficial cervical block. The nerve stimulator needle is first passed over the skin after aseptic preparation from the distal to proximal part of the posterior border of the sternocleidomastoid. Upon contraction of the levator scapulae, a mark is placed and the skin is infiltrated with 1 ml lidocaine 1%. A 22-G, 2.5 cm nerve stimulator needle is subsequently advanced through the skin by 0.5-1 cm depending on patient's weight while passing 5-8.5 mA current at 1 Hz. Then, the stimulating current is reduced to 0.5-0.6 mA while maintaining muscle contraction. At this point, 3-5 ml of the anesthetic mixture is injected. Each 10 ml of the anesthetic mixture contains: 3ml lidocaine 2%, 3 ml lidocaine 2% with epinephrine 1:200,000, 3 ml bupivacaine 0.5% and 1 ml clonidine 150µg/ml. Group II will receive an equivalent volume of normal saline.

Eligibility criteria: Inclusion Criteria:

* older than 18 years,
* have neck shoulder pain non-radiating to the arm,
* tenderness in levator scapulae
* refractory to oral analgesics, antiinflammatory medication and physical therapy
* have negative radiographs and bone scans of the shoulders and cervical spine.

Exclusion Criteria:

* organic disease of the brain or spinal cord,
* radiculopathy,
* malignancy,
* hypothyroidism,
* complete blood count (CBC) with high creatine phosphokinase (CPK)
* myopathy,
* autoimmune diseases that are associated with sub clinical myopathy,
* fibromyalgia,
* coagulopathy
* have allergy to bupivacaine,
* taking glucocorticoid and statins

Primary outcomes:
measure: Analgesic consumption
timeFrame: 2 weeks
Secondary outcomes:
measure: Pain
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
References: