Breast CancerPhase 2NCT03084536

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

A Phase 2 study testing Bupivacaine, Gabapentin and Celecoxib in people with Breast Cancer and Breast Cancer Female, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Breast Cancer Female, Cancer of Breast
What is being tested?: Bupivacaine, Gabapentin and Celecoxib
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 134 participants
Where: 1 siteUnited States
Study dates: 7 Jun 2017to 25 Feb 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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).

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Conditions: Breast Cancer, Breast Cancer Female, Cancer of Breast
Being tested: Bupivacaine, Gabapentin, Celecoxib, Acetaminophen, Midazolam
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BupivacaineDrug
Also called Bupivacaine hydrochloride
-Given after general anesthesia
GabapentinDrug
- As per routine care
- Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
CelecoxibDrug
- 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.
AcetaminophenDrug
-As per routine care
MidazolamDrug
-As per routine care
FentanylDrug
-As per routine care

Study groups in NCT03084536
Study group	Role	What they receive
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 Receives: 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. Receives: Drug: Gabapentin; Drug: Celecoxib; Drug: Acetaminophen; Drug: Midazolam; Drug: Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: At 1 year

Secondary outcomes (2)

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.
Measured: 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.
Measured: At baseline and 1 year post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201725 Feb 2021

First posted21 Mar 2017
Study start7 Jun 2017
Primary completion25 Feb 2021
Study completion25 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03084536
Sponsor's protocol ID: 201703053
Status last verified: Dec 2024
First submitted: 8 Mar 2017
Last updated: 24 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
ClinicalTrials.gov ID: NCT03084536
Acronym / sponsor ID: 201703053
Conditions: Breast Cancer, Breast Cancer Female, Cancer of Breast
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 7 Jun 2017 (actual)
Primary completion: 25 Feb 2021 (actual)
Study completion: 25 Feb 2021 (actual)
First posted: 21 Mar 2017 (actual)
Results: Posted 31 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Preoperative PECS blocks	Active comparator	Drug: Bupivacaine, Drug: Gabapentin, Drug: Celecoxib, Drug: Acetaminophen, Drug: Midazolam, Drug: 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	Placebo comparator	Drug: Gabapentin, Drug: Celecoxib, Drug: Acetaminophen, Drug: Midazolam, Drug: 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Scheduled to undergo elective breast cancer surgeries at Barnes-Jewish Hospital:
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).

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BupivacaineAlso: Bupivacaine hydrochloride-Given after general anesthesia	Drug	Preoperative PECS blocks
Gabapentin* As per routine care * Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.	Drug	Placebo PECS blocks, Preoperative PECS blocks
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	Placebo PECS blocks, Preoperative PECS blocks
Acetaminophen-As per routine care	Drug	Placebo PECS blocks, Preoperative PECS blocks
Midazolam-As per routine care	Drug	Placebo PECS blocks, Preoperative PECS blocks
Fentanyl-As per routine care	Drug	Placebo PECS blocks, Preoperative PECS blocks

Primary outcome

Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
Time frame: 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.
Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
Time frame: 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
Time frame: 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.

2 secondary outcomes

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

Results and safety

Results posted to the registry on 31 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Preoperative PECS Blocks	53	53
Placebo PECS Blocks	54	54
Not Randomized to an Arm	27	0

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

Time frame: At 1 year. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Preoperative PECS Blocks n = 29	Placebo PECS Blocks n = 32
Value	0 (0 to 1)	0 (0 to 0.8)

Preoperative PECS Blocks vs Placebo PECS Blocks: p = 0.68, Kruskal-Wallis

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

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

Time frame: At 1 year. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Preoperative PECS Blocks n = 29	Placebo PECS Blocks n = 32
Value	0 (0 to 0.2)	0 (0 to 0.2)

Preoperative PECS Blocks vs Placebo PECS Blocks: p = 0.67, Kruskal-Wallis

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

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

Time frame: At 1 year. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Preoperative PECS Blocks n = 28	Placebo PECS Blocks n = 32
Value	0 (0 to 0)	0 (0 to 0)

Preoperative PECS Blocks vs Placebo PECS Blocks: p = 0.53, Kruskal-Wallis

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: -Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Preoperative PECS Blocks	0 of 53 (0%)	5 of 53 (9.4%)	1 of 53
Placebo PECS Blocks	0 of 54 (0%)	0 of 54 (0%)	0 of 54
Not Randomized to an Arm	0 of 0	0 of 0	1 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ryan C Guffey, M.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bupivacaine, Gabapentin and Celecoxib in people with Breast Cancer and Breast Cancer Female, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year (time frame: At 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03084536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.