Pectoralis Block vs Paravertebral Nerve Blocks for Breast Surgery

NCT04742309 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pecs vs PVB
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Surgery

Keywords

Regional Anesthesia; Pecs-2; Paravertebral nerve block

Outcome Measures

Primary Outcomes (2)

• Recovery Room Numeric Rating Scale Pain Scores

  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.

  From arrival in the recovery room until recovery room discharge, assessed up to 12 hours total

• Cumulative Operating and Recovery Room Opioid Consumption

  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.

  From entering the operating room until recovery room discharge, assessed up to 24 hours

Secondary Outcomes (9)

• Nausea and Vomiting

  Recovery room discharge until data collection call on Postoperative Day 1

• Time of First Opioid Use

  Recovery room discharge until data collection call on Postoperative Day 1

• Time of Block Resolution

  Recovery room discharge until data collection call on Postoperative Day 1

• Opioid (Oxycodone) Consumption

  Recovery room discharge until data collection call on Postoperative Day 1

• Worst Pain Measured Using the Numeric Rating Scale Pain Score

  Recovery room discharge until data collection call on Postoperative Day 1

Study Arms (2)

Pecs-2

EXPERIMENTAL

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)

Paravertebral

ACTIVE COMPARATOR

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)

Interventions

Pecs-2 block (single injection) DRUG

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.

Pecs-2

Paravertebral block (single injection) DRUG

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.

Paravertebral

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University Of California San Diego

San Diego, California, 92103, United States

Location

Related Publications (1)

• Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

  PMID: 25376971 BACKGROUND

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Brian Ilfeld, MD, MS
• Organization: University of California San Diego

bilfeld@health.ucsd.edu

(858) 822-0776

Study Officials

• Brian M Ilfeld, MD,MS

  UCSD Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 8, 2021
• Study Start: February 25, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)