Superficial Cervical Plexus Block for Neck and Shoulder Pain
Primary Purpose
Neck Pain, Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Superficial cervical plexus block
Placebo
Sponsored by
About this trial
This is an interventional other trial for Neck Pain
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
Sites / Locations
- Makassed General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Block
Placebo
Arm Description
Patients will receive superficial cervical plexus block
Patients will receive normal saline
Outcomes
Primary Outcome Measures
Analgesic consumption
Patients will record the type and amount of analgesics they consume daily
Secondary Outcome Measures
Pain
Patients will record their pain using the Visual Analogue Scale (VAS)
Full Information
NCT ID
NCT03210181
First Posted
July 4, 2017
Last Updated
February 12, 2018
Sponsor
Makassed General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03210181
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 4, 2017 (Actual)
Primary Completion Date
January 26, 2018 (Actual)
Study Completion Date
January 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Shoulder Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Block
Arm Type
Experimental
Arm Description
Patients will receive superficial cervical plexus block
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive normal saline
Intervention Type
Other
Intervention Name(s)
Superficial cervical plexus block
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients will receive an equivalent volume of normal saline
Primary Outcome Measure Information:
Title
Analgesic consumption
Description
Patients will record the type and amount of analgesics they consume daily
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Pain
Description
Patients will record their pain using the Visual Analogue Scale (VAS)
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
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Superficial Cervical Plexus Block for Neck and Shoulder Pain
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