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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Cancer Female; Cancer of Breast
• Intervention / Treatment: Drug: Bupivacaine; Drug: Gabapentin; Drug: Celecoxib; Drug: Acetaminophen; Drug: Midazolam; Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Preoperative PECS blocks; PECS I & II block will be administered preoperatively; For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL); To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number; Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist	Drug: Bupivacaine; -Given after general anesthesia; Other Names: Bupivacaine hydrochloride; Drug: Gabapentin; As per routine care; Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.; Drug: Celecoxib; 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.; Drug: Acetaminophen; -As per routine care; Drug: Midazolam; -As per routine care; Drug: Fentanyl; -As per routine care
PLACEBO_COMPARATOR: Placebo PECS blocks; A sham block (normal saline) will be placed preoperatively; To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number.; Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist.	Drug: Gabapentin; As per routine care; Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.; Drug: Celecoxib; 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.; Drug: Acetaminophen; -As per routine care; Drug: Midazolam; -As per routine care; Drug: Fentanyl; -As per routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst Pain as Measured by the Brief Pain Inventory (BPI) 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.	At 1 year
Average Pain as Measured by the Brief Pain Inventory (BPI) 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.	At 1 year
Interference as Measured by the Brief Pain Inventory (BPI) 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.	At 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure	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.	At baseline and 1 year post-surgery
Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure	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.	At baseline and 1 year post-surgery

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Ryan C Guffey, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 7, 2017
• Primary Completion (ACTUAL): February 25, 2021
• Study Completion (ACTUAL): February 25, 2021

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (ACTUAL): March 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Breast Diseases; Pain, Postoperative; Breast Neoplasms; Mastodynia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Anesthetics, Local; Antimanic Agents; Cyclooxygenase 2 Inhibitors; Fentanyl; Midazolam; Gabapentin; Celecoxib; Acetaminophen; Bupivacaine
• Other Study ID Numbers: 201703053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: No