Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pectoralis Block vs Paravertebral Nerve Blocks for Breast Surgery

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: NCT04742309
Recruitment Status : Enrolling by invitation
First Posted : February 8, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:
Following painful surgical procedures of the breast, postoperative analgesia is often provided with a nerve block called a "paravertebral" block. For intense, but shorter-duration acute pain, a single-injection of numbing medicine is used which lasts about 12 hours. Recently, a new type of block has been reported: the "Pecs-2" block. The theoretical benefits include ease of administration since it is closer to the skin (less deep) compared with the paravertebral block and therefore easier to identify and target with ultrasound (therefore increasing success rate); and, a lower risk of complications. Lastly, it might be easier to insert a tiny tube which would allow additional numbing medicine to be injected. There are, therefore, multiple theoretical reasons to prefer the Pecs-2 over the paravertebral nerve block. Unfortunately, it remains unknown if the pain control provided by this new type of block is comparable to that provided with the older block. The investigators therefore propose to compare these two blocks with a clinical study.

Condition or disease Intervention/treatment Phase
Breast Surgery Drug: Pecs-2 block (single injection) Drug: Paravertebral block (single injection) Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Anesthesia teams in the operating rooms and recovery room nurses will be masked to treatment group assignment (therefore, the primary outcome measure collection). Outcomes assessor for the questionnaire involving secondary outcomes on the day following surgery will not be masked to treatment group, although subjects will remain masked.
Primary Purpose: Treatment
Official Title: A Randomized, Subject-Masked, Active-Controlled, Parallel-Arm Clinical Trial Comparing Pecs-2 and Paravertebral Nerve Blocks
Actual Study Start Date : February 25, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 2, 2022

Arm Intervention/treatment
Experimental: Pecs-2
For Pecs-2 blocks, the needle will be advanced to the tissue plane between the pectoralis major and minor muscles at the vicinity of the pectoral branch of the acromiothoracic artery where 10 mL of local anesthetic will be deposited. In a similar manner, 20 mL will be deposited at the level of the third rib above the serratus anterior muscle with the intent of spreading injectate to the axilla. The study fluid will be ropivacaine 0.3% with epinephrine.
Drug: Pecs-2 block (single injection)
For Pecs-2 blocks, the needle will be advanced to the tissue plane between the pectoralis major and minor muscles at the vicinity of the pectoral branch of the acromiothoracic artery where 10 mL of local anesthetic will be deposited. In a similar manner, 20 mL will be deposited at the level of the third rib above the serratus anterior muscle with the intent of spreading injectate to the axilla. The study fluid will be ropivacaine 0.3% with epinephrine.

Active Comparator: Paravertebral
For paravertebral blocks, ropivacaine 0.5% (with epinephrine) 9 mL will be administered at each of two levels per side: the T3 and T5 levels for sides without axillary involvement; and at the T2 and T4 level for sides with axillary involvement.
Drug: Paravertebral block (single injection)
For paravertebral blocks, ropivacaine 0.5% (with epinephrine) 9 mL will be administered at each of two levels per side: the T3 and T5 levels for sides without axillary involvement; and at the T2 and T4 level for sides with axillary involvement.




Primary Outcome Measures :
  1. Recovery Room Numeric Rating Scale Pain Scores [ Time Frame: From arrival in the recovery room until recovery room discharge, assessed up to 12 hours total ]
    Numeric Rating Scale: the NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which the study subject selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. This 11-point numeric scale ranges from 0 representing "no pain" to 10 representing "worst imaginable pain." Higher numeric scores represent increased pain and thus worse outcomes. Of note, in order to claim that Pecs-2 blocks are non-inferior to paravertebral blocks, both Hypotheses 1 and 2 must be at least non-inferior.

  2. Cumulative Operating and Recovery Room Opioid Consumption [ Time Frame: From entering the operating room until recovery room discharge, assessed up to 24 hours ]
    The morphine equivalents consumed in both the operating and recovery rooms. Of note, in order to claim that Pecs-2 blocks are non-inferior to paravertebral blocks, both Hypotheses 1 and 2 must be at least non-inferior.


Secondary Outcome Measures :
  1. Nausea and vomiting [ Time Frame: Recovery room discharge until data collection call on Postoperative Day 1 ]
    0-10 Likert scale (0 = no nausea; 10 = vomiting)

  2. Time of first opioid use [ Time Frame: Recovery room discharge until data collection call on Postoperative Day 1 ]
  3. Time of block resolution [ Time Frame: Recovery room discharge until data collection call on Postoperative Day 1 ]
  4. Opioid consumption [ Time Frame: Recovery room discharge until data collection call on Postoperative Day 1 ]
  5. Worst pain measured using the Numeric Rating Scale pain score [ Time Frame: Recovery room discharge until data collection call on Postoperative Day 1 ]
    Numeric Rating Scale: the NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which the study subject selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. This 11-point numeric scale ranges from 0 representing "no pain" to 10 representing "worst imaginable pain." Higher numeric scores represent increased pain and thus worse outcomes.

  6. Lowest pain measured using the Numeric Rating Scale pain score [ Time Frame: Recovery room discharge until data collection call on Postoperative Day 1 ]
    Numeric Rating Scale: the NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which the study subject selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. This 11-point numeric scale ranges from 0 representing "no pain" to 10 representing "worst imaginable pain." Higher numeric scores represent increased pain and thus worse outcomes.

  7. Average pain measured using the Numeric Rating Scale pain score [ Time Frame: Recovery room discharge until data collection call on Postoperative Day 1 ]
    Numeric Rating Scale: the NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which the study subject selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. This 11-point numeric scale ranges from 0 representing "no pain" to 10 representing "worst imaginable pain." Higher numeric scores represent increased pain and thus worse outcomes.

  8. Current pain measured using the Numeric Rating Scale pain score [ Time Frame: Postoperative Day 1 ]
    Numeric Rating Scale: the NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which the study subject selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. This 11-point numeric scale ranges from 0 representing "no pain" to 10 representing "worst imaginable pain." Higher numeric scores represent increased pain and thus worse outcomes.

  9. Awakenings due to pain [ Time Frame: Evening of surgery ]
    The number of times subject recalls awakening from sleep due to pain



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:

  1. Undergoing unilateral or bilateral breast surgery with at least moderate postoperative pain anticipated.
  2. Analgesic plan includes a single-injection peripheral nerve block(s).
  3. Age 18 years or older.

Exclusion Criteria:

  1. Morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2).
  2. Renal insufficiency ( abnormal preoperative creatinine or eGFR)
  3. Chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks).
  4. History of opioid abuse.
  5. Any comorbidity which results in moderate or severe functional limitation inability to communicate with the investigators or hospital staff.
  6. Inability to communicate with the investigators or hospital staff.
  7. Pregnancy
  8. Planned regional analgesic with perineural catheter placement
  9. Incarceration
  10. Known allergy to amide local anesthetics.

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): NCT04742309


Locations
Layout table for location information
United States, California
University Of California San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Layout table for investigator information
Principal Investigator: Brian M Ilfeld, MD,MS UCSD Medical Center
Publications:
Layout table for additonal information
Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04742309    
Other Study ID Numbers: Pecs vs PVB
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:
Regional Anesthesia
Pecs-2
Paravertebral nerve block