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Completed

NCT Number: NCT03084536

PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast surgery involving the axilla will be administered a multimodal pain regimen including acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.

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Key information

Conditions

Breast Cancer Breast Cancer Female Breast Diseases Breast Neoplasms Cancer of Breast Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled to undergo elective breast cancer surgeries at Barnes-Jewish Hospital:
  • unilateral axillary dissection
  • unilateral modified radical mastectomy
  • mastectomy with same day unilateral reconstruction
  • unilateral sentinel lymph node biopsy (SLNB)
  • partial mastectomy with unilateral SLNB
  • simple mastectomy with unilateral SLNB
  • At least 18 years of age.
  • Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
  • Enrollment in the SATISFY-SOS study (WUSTL IRB# 201203088, NCT02032030).

Exclusion criteria

  • Planned for bilateral axillary or bilateral reconstruction surgery.
  • Previous surgery on the surgical breast and/or axilla with the exception of partial mastectomy or sentinel lymph node biopsy
  • Pre-existing pain in the axilla affecting the ability to use extremity for activities of daily living or requiring medication for treatment.
  • Current or past medical history of liver disease or cirrhosis with an elevated INR >1.4 or currently elevated transaminase levels.
  • Known contraindications to peripheral nerve block placement.
  • Pregnant or breastfeeding.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition
  • Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy)

Treatment and study plan

Bupivacaine

Drug

-Given after general anesthesia

Other names: Bupivacaine hydrochloride

Gabapentin

Drug
  • As per routine care
  • Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.

Celecoxib

Drug
  • As per routine care
  • Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
  • Naproxen will be substituted for celecoxib in patients with sulfa allergies.

Acetaminophen

Drug

-As per routine care

midazolam

Drug

-As per routine care

Fentanyl

Drug

-As per routine care

Primary outcomes

  1. Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year

    Time frame: At 1 year

    • The participant is asked to rate their pain by circling the one number that best describes their pain at its worst in the past week.
    • 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.

  2. Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year

    Time frame: At 1 year

    • The participant is asked to rate their pain by circling the one number that best describes their pain on the average.
    • 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.

  3. Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year

    Time frame: At 1 year

    • The participant is asked circle the one number that describes how much, during the past week pain has interfered with general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, sleep, and enjoyment of life.
    • 0=does not interference and 10 = completely interferes. The higher number indicates more interference from pain.
    • The scores for each subsection will be averaged.

Secondary outcomes

  1. Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure

    Time frame: At baseline and 1 year post-surgery

    • The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).
    • The higher the score the better quality of life.
    • Scores are standardized to a mean of 50 with a range of -0.809-70.71.

  2. Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure

    Time frame: At baseline and 1 year post-surgery

    • The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).
    • The higher the score the better quality of life.
    • Scores are standardized to a mean of 50 with a range of -1.465-77.09.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 21, 2017
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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