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

Phase 2

Completed

Conditions: Breast Cancer Female
Cancer of Breast
Breast Cancer

Interventions: Drug: Bupivacaine
Drug: Gabapentin
Drug: Celecoxib
Drug: Acetaminophen
Drug: Midazolam
Drug: Fentanyl

Registration Number: NCT03084536

Lead Sponsor: Washington University School of Medicine

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 134

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative PECS blocks	Bupivacaine	* 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
Preoperative PECS blocks	Gabapentin	* 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
Preoperative PECS blocks	Celecoxib	* 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
Preoperative PECS blocks	Acetaminophen	* 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
Preoperative PECS blocks	Midazolam	* 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
Placebo PECS blocks	Gabapentin	* 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.
Placebo PECS blocks	Celecoxib	* 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.
Placebo PECS blocks	Acetaminophen	* 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.
Preoperative PECS blocks	Fentanyl	* 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
Placebo PECS blocks	Midazolam	* 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.
Placebo PECS blocks	Fentanyl	* 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.

Primary Outcome Measures

Name	Time	Method
Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year	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.
Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year	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.
Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year	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.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure	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.
Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure	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.