Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Superficial Cervical Plexus Block for Neck and Shoulder Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210181
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Zoher Naja, Makassed General Hospital

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.


Condition or disease Intervention/treatment Phase
Neck Pain Shoulder Pain Other: Superficial cervical plexus block Other: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Superficial Cervical Plexus Block for Neck and Shoulder Pain Due to Levator Scapulae Syndrome: a Randomized, Double Blind Clinical Trial
Actual Study Start Date : July 4, 2017
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : January 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Block
Patients will receive superficial cervical plexus block
Other: Superficial cervical plexus block
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.

Placebo Comparator: Placebo
Patients will receive normal saline
Other: Placebo
Patients will receive an equivalent volume of normal saline




Primary Outcome Measures :
  1. Analgesic consumption [ Time Frame: 2 weeks ]
    Patients will record the type and amount of analgesics they consume daily


Secondary Outcome Measures :
  1. Pain [ Time Frame: 2 weeks ]
    Patients will record their pain using the Visual Analogue Scale (VAS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210181


Locations
Layout table for location information
Lebanon
Makassed General Hospital
Beirut, Lebanon
Sponsors and Collaborators
Makassed General Hospital
Layout table for additonal information
Responsible Party: Zoher Naja, Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT03210181    
Other Study ID Numbers: 1072013
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Pain
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases