Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Pain, Postoperative

Pain

Mastodynia

Breast Diseases

Skin Diseases

Postoperative Complications

Neurologic Manifestations

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Anti-Inflammatory Agents

Antirheumatic Agents

Antipyretics

Pharmaceutical Solutions

Psychotropic Drugs

Anticonvulsants

Anesthetics

Bupivacaine

Fentanyl

Naproxen

Acetaminophen

Midazolam

Celecoxib

Gabapentin

Anesthetics, Local

Hypnotics and Sedatives

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Neurotransmitter Agents

Analgesics, Opioid

Narcotics

Analgesics, Non-Narcotic

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Excitatory Amino Acid Antagonists

* 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

* 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.

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

* 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.

Ryan C Guffey, M.D.

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.

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

* 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.

* 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.

* 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.

* 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.

* 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.

Washington University School of Medicine

Participants in the Not Randomized Arm were not assess for Serious and Other Adverse Events as they did not receive any study treatment or placebo.

Preoperative PECS Blocks

Placebo PECS Blocks

-Participants were removed from the study prior to being randomized into an Arm and did not receive any treatment on the study.

Not Randomized to an Arm

-Participants were removed from the study prior to being randomized into an Arm.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Ryan C. Guffey, M.D.

Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure.

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

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

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

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

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

Overall Study

Spots Global Cancer Trial Database for PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial