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

NCT03084536 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201703053
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Breast Cancer Female; Cancer of Breast

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

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

  At baseline and 1 year post-surgery

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

  At baseline and 1 year post-surgery

Study Arms (2)

Preoperative PECS blocks

ACTIVE COMPARATOR

* 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; Drug: Gabapentin; Drug: Celecoxib; Drug: Acetaminophen; Drug: Midazolam; Drug: Fentanyl

Placebo PECS blocks

PLACEBO COMPARATOR

* 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; Drug: Celecoxib; Drug: Acetaminophen; Drug: Midazolam; Drug: Fentanyl

Interventions

Bupivacaine DRUG

-Given after general anesthesia

Also known as: Bupivacaine hydrochloride

Preoperative PECS blocks

Gabapentin DRUG

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

Placebo PECS blocks; Preoperative PECS blocks

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.

Placebo PECS blocks; Preoperative PECS blocks

Acetaminophen DRUG

-As per routine care

Placebo PECS blocks; Preoperative PECS blocks

Midazolam DRUG

-As per routine care

Placebo PECS blocks; Preoperative PECS blocks

Fentanyl DRUG

-As per routine care

Placebo PECS blocks; Preoperative PECS blocks

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bupivacaine; Gabapentin; Celecoxib; Acetaminophen; Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines

Results Point of Contact

• Title: Ryan C. Guffey, M.D.
• Organization: Washington University School of Medicine

rguffey@wustl.edu

314-286-2883

Study Officials

• Ryan C Guffey, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 21, 2017
• Study Start: June 7, 2017
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: December 24, 2024
• Results First Posted: March 31, 2022

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)