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Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery (SCPB)

This study has been terminated.
(Unable to continue enrollment due to lack of resources (research coordinator no longer available).)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550302
First Posted: March 9, 2012
Last Update Posted: July 18, 2017
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.
Information provided by (Responsible Party):
Srdjan Jelacic, University of Washington
Results First Submitted: March 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Shoulder Pain
Interventions: Procedure: Superficial Cervical Plexus Block
Drug: Bupivacaine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Controls 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

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.

Superficial Cervical Plexus Block: 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.

Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously


Participant Flow:   Overall Study
    Controls   Superficial Cervical Plexus Block
STARTED   5   5 
COMPLETED   5   5 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Controls 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

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.

Superficial Cervical Plexus Block: 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.

Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously

Total Total of all reporting groups

Baseline Measures
   Controls   Superficial Cervical Plexus Block   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.8  (8.7)   58.8  (6.7)   58.8  (7.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  20.0%      5 100.0%      6  60.0% 
Male      4  80.0%      0   0.0%      4  40.0% 
Region of Enrollment 
[Units: Participants]
     
United States   5   5   10 
Height 
[Units: Cm]
Mean (Standard Deviation)
 181.0  (7.6)   156.4  (4.6)   168.7  (13.8) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 89.7  (6.0)   66.2  (18.7)   77.9  (18.2) 
Duration of Surgery 
[Units: Minutes]
Mean (Standard Deviation)
 181  (70)   251  (108)   216  (96) 


  Outcome Measures
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1.  Primary:   Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain   [ Time Frame: 24 hours after lung surgery ]

2.  Secondary:   Post-operative Opioid Consumption Expressed in Morphine Equivalents   [ Time Frame: 24 hours after the surgery ]

3.  Secondary:   Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement   [ Time Frame: 6, 12, 18, 24 and 48 hours after the surgery ]

4.  Secondary:   Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing   [ Time Frame: 6, 12, 18, 24 and 48 hours after the surgery ]

5.  Secondary:   Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing   [ Time Frame: 6, 12, 18, 24 and 48 hours after the surgery ]

6.  Secondary:   Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication   [ Time Frame: 48 hours after the surgery ]

7.  Secondary:   Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension   [ Time Frame: 24 and 48 hours after the surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Srdjan Jelacic
Organization: University of Washington
phone: (206) 598-3777
e-mail: sjelacic@uw.edu


Publications:

Responsible Party: Srdjan Jelacic, University of Washington
ClinicalTrials.gov Identifier: NCT01550302     History of Changes
Other Study ID Numbers: 42272
First Submitted: March 1, 2012
First Posted: March 9, 2012
Results First Submitted: March 23, 2017
Results First Posted: May 4, 2017
Last Update Posted: July 18, 2017