Trial Outcomes & Findings for Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery (NCT NCT01550302)

NCT ID: NCT01550302

Last Updated: 2017-07-18

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome timeframe: 24 hours after lung surgery
• Results posted on: 2017-07-18

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery

Baseline characteristics by cohort

Measure	Controls n=5 Participants 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 n=5 Participants 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 n=10 Participants Total of all reporting groups
Age, Continuous	58.8 years STANDARD_DEVIATION 8.7 • n=5 Participants	58.8 years STANDARD_DEVIATION 6.7 • n=7 Participants	58.8 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Height	181.0 cm STANDARD_DEVIATION 7.6 • n=5 Participants	156.4 cm STANDARD_DEVIATION 4.6 • n=7 Participants	168.7 cm STANDARD_DEVIATION 13.8 • n=5 Participants
Weight	89.7 kg STANDARD_DEVIATION 6.0 • n=5 Participants	66.2 kg STANDARD_DEVIATION 18.7 • n=7 Participants	77.9 kg STANDARD_DEVIATION 18.2 • n=5 Participants
Duration of Surgery	181 minutes STANDARD_DEVIATION 70 • n=5 Participants	251 minutes STANDARD_DEVIATION 108 • n=7 Participants	216 minutes STANDARD_DEVIATION 96 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after lung surgery

Outcome measures

Measure	Controls n=5 Participants 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 n=5 Participants 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
Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 24 hours after the surgery

Outcome measures

Measure	Controls n=5 Participants 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 n=5 Participants 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
Post-operative Opioid Consumption Expressed in Morphine Equivalents	30.0 mg Standard Deviation 39.16	17.2 mg Standard Deviation 17.5

SECONDARY outcome

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

Population: Data not collected for 6, 12, and 18 hours at rest or with movement/coughing

Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants

Outcome measures

Measure	Controls n=5 Participants 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 n=5 Participants 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
Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement At rest 24 hrs	2.8 units on a scale Standard Deviation 4.21	4 units on a scale Standard Deviation 3.00
Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement With movement 24 hrs	2.8 units on a scale Standard Deviation 4.21	5.6 units on a scale Standard Deviation 3.13
Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement At rest 48 hrs	2.2 units on a scale Standard Deviation 3.03	4.6 units on a scale Standard Deviation 4.62
Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement With movement 48 hrs	3.4 units on a scale Standard Deviation 3.13	5.8 units on a scale Standard Deviation 4.38

SECONDARY outcome

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

Population: Data not collected for 6, 12, and 18 hours at rest or moving/with cough

Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants

Outcome measures

Measure	Controls n=5 Participants 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 n=5 Participants 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
Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing At rest 24 hrs	4.4 units on a scale Standard Deviation 4.04	3.2 units on a scale Standard Deviation 4.38
Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing Movement or cough 24 hrs	5.2 units on a scale Standard Deviation 4.15	7 units on a scale Standard Deviation 4.06
Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing At rest 48 hrs	1.6 units on a scale Standard Deviation 2.19	3.4 units on a scale Standard Deviation 4.67
Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing Movement or cough 48 hrs	3.8 units on a scale Standard Deviation 3.03	5.2 units on a scale Standard Deviation 4.15

SECONDARY outcome

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

Population: Data not collected for 6, 12, and 18 hours at rest or with movement/cough

Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants

Outcome measures

Measure	Controls n=5 Participants 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 n=5 Participants 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
Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing At rest 24 hrs	2.6 units on a scale Standard Deviation 2.88	5.8 units on a scale Standard Deviation 4.44
Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing Movement or cough 24 hrs	3.6 units on a scale Standard Deviation 3.58	7.2 units on a scale Standard Deviation 3.56
Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing At rest 48 hrs	1.6 units on a scale Standard Deviation 2.61	2.2 units on a scale Standard Deviation 2.59
Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing Movement or cough 48 hrs	4.2 units on a scale Standard Deviation 3.11	5.2 units on a scale Standard Deviation 3.70

SECONDARY outcome

Timeframe: 48 hours after the surgery

Outcome measures

Measure	Controls n=5 Participants 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 n=5 Participants 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
Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication	0 number of participants	1 number of participants

SECONDARY outcome

Timeframe: 24 and 48 hours after the surgery

Population: Hypotension data not collected

Outcome measures

Measure	Controls n=5 Participants 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 n=5 Participants 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
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension PONV 24 hrs	2 Participants	1 Participants
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension PONV 48 hrs	2 Participants	4 Participants
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension Pruritis 24 hrs	1 Participants	1 Participants
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension Pruritis 48 hrs	2 Participants	0 Participants
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension Dizziness 24 hrs	0 Participants	0 Participants
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension Dizziness 48 hrs	0 Participants	1 Participants
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension Sedation 24 hrs	1 Participants	0 Participants
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension Sedation 48 hrs	0 Participants	0 Participants
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension Respiratory Depression 24 hrs	1 Participants	0 Participants
Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension Respiratory Depression 48 hrs	1 Participants	0 Participants

Adverse Events

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Superficial Cervical Plexus Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Srdjan Jelacic

University of Washington

Phone: (206) 598-3777

Email: sjelacic@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place