Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery

NCT01550302 | Terminated Phase 4 Results DMC

• 1 other identifier: 42272
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

Superficial Cervical Plexus Block; Thoracic Surgery; Thoracotomy; Video-Assisted Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain

  24 hours after lung surgery

Secondary Outcomes (6)

• Post-operative Opioid Consumption Expressed in Morphine Equivalents

  24 hours after the surgery

• Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement

  6, 12, 18, 24 and 48 hours after the surgery

• Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing

  6, 12, 18, 24 and 48 hours after the surgery

• Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing

  6, 12, 18, 24 and 48 hours after the surgery

• Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication

  48 hours after the surgery

Study Arms (2)

Controls

NO INTERVENTION

Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.

Superficial Cervical Plexus Block

ACTIVE COMPARATOR

Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.

Procedure: Superficial Cervical Plexus Block; Drug: Bupivacaine

Interventions

Superficial Cervical Plexus Block PROCEDURE

At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a "fan" technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.

Also known as: Cervical Plexus Block

Superficial Cervical Plexus Block

Bupivacaine DRUG

Single dose of 37.5 mg of bupivacaine subcutaneously

Also known as: Marcain, Marcaine, Sensorcaine and Vivacaine

Superficial Cervical Plexus Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

• MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67.

  PMID: 18195603 BACKGROUND

• 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.

  PMID: 8439033 BACKGROUND

• 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.

  PMID: 14570798 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Interventions

Cervical Plexus Block; Bupivacaine

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Srdjan Jelacic
• Organization: University of Washington

sjelacic@uw.edu

(206) 598-3777

Study Officials

• Srdjan Jelacic, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 9, 2012
• Study Start: October 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 18, 2017
• Results First Posted: May 4, 2017

Record last verified: 2017-06

Locations

US (1)