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

The Washington University

Status and phase: Completed; Phase 2

Conditions: Cancer of Breast; Breast Cancer; Breast Cancer Female

Treatments: Drug: Midazolam; Drug: Acetaminophen; Drug: Celecoxib; Drug: Gabapentin; Drug: Fentanyl; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03084536

201703053

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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134 participants in 2 patient groups, including a placebo group

Preoperative PECS blocks

Active Comparator group

Description:

* 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

Treatment:

Drug: Fentanyl

Drug: Bupivacaine

Drug: Celecoxib

Drug: Gabapentin

Drug: Acetaminophen

Drug: Midazolam

Placebo PECS blocks

Placebo Comparator group

Description:

* 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.

Treatment:

Drug: Fentanyl

Drug: Celecoxib

Drug: Gabapentin

Drug: Acetaminophen

Drug: Midazolam