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Breast CancerPECSNCT04086394

PECS Block in Partial Mastectomy for Postoperative Pain Control

A study testing Pectoral Nerve Block and Surgery without Nerve Block in people with Breast Cancer and Postoperative Pain, run by Main Line Health at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to evaluate patients who are undergoing partial mastectomy or removal of breast tissue and see if a pectoralis nerve block (PECS) can provide a meaningful improvement in postoperative pain control over standard pain medication. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Postoperative Pain, Opioid Use
What is being tested?
Pectoral Nerve Block and Surgery without Nerve Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
1 siteUnited States
Study dates
1 Sep 2019to 1 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Inclusion criteria are patients are undergoing a partial mastectomy or excisional biopsy. Patients may undergo additional procedures such as sentinel lymph node biopsy or axillary lymph node dissection which will be recorded.

Who cannot join

  • Chronic Pain, Presence of Breast Implants prior to surgery

Trial locations and contacts

1 site in 1 country.

Kaitlyn Kennard, MD contact

610-642-1908

kennardk@mlhs.org

Robin Ciocca, MD contact

610-642-1908

cioccar@mlhs.org

United States1 site, 1 recruiting
  • Kaitlyn Kennard

    Philadelphia, Pennsylvania, 19147

    Kaitlyn Kennard, MD, 610-642-1908, kennardk@mlhs.org

    Kaitlyn Kennard, MD

    Recruiting

Other trials in United States

About this study

Official title: Use of PECS Block in Partial Mastectomy for Postoperative Pain Control and Mitigation of Narcotic Use- A Randomized Control Trial

The aim of this study is to evaluate patients who are undergoing partial mastectomy or removal of breast tissue and see if a pectoralis nerve block (PECS) can provide a meaningful improvement in postoperative pain control over standard pain medication. The hope is that this will decrease the need for postoperative narcotics. Prior studies have shown improved pain control using a PECS block in patients who undergo a mastectomy. PECS block is a procedure in which local anesthesia, similar to that used by dentists, is injected in the muscles of your chest and arm pit during your surgical procedure while you are asleep. This anesthetizes the nerves in the area which decreases pain. The local anesthetic used is called Marcaine. Marcaine is the brand name for bupivacaine hydrochloride which is an anesthetic known for its long duration in comparison to lidocaine.

It is known that postoperative pain is a risk factor for chronic pain which is tied to increased narcotic use. Due to the opioid epidemic considerable time and research has gone into decreasing opioid use particularly in post-operative period. The PECS block procedure involves injecting local anesthesia between two chest muscles called pectoralis major and pectoralis minor. There is an additional injection between the pectoralis minor and serratus anterior which is another muscle of the chest.

This study will be conducted at Lankenau Medical Center of Main Line Health. You have been selected since you will be undergoing a partial mastectomy (removal of a part of your breast). It is believed that PECS block has the potential to benefit your postoperative pain control. A total of 130 patients will be recruited and 65 will be placed into the treatment arm (receive intraoperative nerve block) and 65 will be placed into the non- treatment arm (no nerve block) for comparison.

Read the detailed description

Prior investigations have shown that use of intraoperative PECS blocks in patients undergoing a Modified Radical Mastectomy improves postoperative pain control and decreases postoperative narcotic use which will eventually mitigate the issue of dependence on narcotics postoperatively (Kulhari et al, Blanco et al). The aim of this study is to do a prospective randomized control of patients undergoing a Partial Mastectomy at Lankenau Medical Center to see if pectoral nerve block (PECS) provides a meaningful improvement in postoperative pain control over standard pain medication as well as a decrease in postoperative narcotic use.

PECS block as described by Blanco et al has been used safely and effectively used for modified radical mastectomy in multiple studies as reviewed above (Blanco et al, Kumar et al, Kulhari et al). The breast surgeons at Lankenau Medical Center within Main Line Health are currently using the PECS block as part of their partial mastectomy procedure and have been since 5/1/19. The PECS block is currently being used at random when time and resources allow There are not certain subsets or patients who are selected for this procedure. This procedure has been well tolerated by patients and has proved feasible for the surgeons and surgical team to facilitate. Therefore since PECS block for partial mastectomy are within the standard of care at Lankenau Medical Center this study only introduces a risk of randomization rather than the increased risk of the procedure itself.

This is a randomized prospective control study looking at patients at Lankenau Hospital undergoing partial mastectomy from 8/30/19- 8/30/20 after obtaining Institutional Review Board (IRB) approval. The plan is to recruit 130 patients with 65 patients randomized into each cohort. One cohort will receive the PECS II block intraoperatively and one cohort will not. This will be a single blinded randomized control trial in that the surgeon knows who will be receiving the block however the patient will be blinded. Patient must be able to provide their own consent to be included in this study. There will be no advertisement or compensation for this study. The study will be explained to the eligible candidates at time of discussion of their surgery. Patients will be informed that involvement in the study does not affect their ability to seek or receive care at this facility.

A written informed consent will be obtained from all patients. The patients once scheduled for surgery unit will be enrolled in research study by an independent research assistant. The participants will be allocated randomly into two groups according to block randomization schedule shown below. Group one will receive anesthesia only and Group two will receive anesthesia and PECS block. The surgeon who will be performing the intraoperative block will be informed of the random and independent assignment prior to surgery. The patients will be instructed on usage of a 10-mm Visual Analogue Scale (VAS) for pain graded from 0 (no pain) to 10 (most severe pain) before surgery. Patients will be blinded as to whether or not they will be receiving intraoperative PECS block. In both the control and test groups, patients will receive general anesthesia with laryngeal mask airway or endotracheal tube per anesthesiologist discretion. Induction of anesthesia will use fentanyl 1 μg/kg and propofol 1.5-2 mg/kg until loss of verbal response with or without muscle relaxant as needed. Maintenance of anesthesia will be assessed for any intraoperative rise in heart rate and systolic blood pressure more than 20% from pre-induction value. If this occurs fentanyl 0.25 μg/kg can be administered IV. Toradol should be given unless contraindication at the end of the case. No ketamine or dilaudid will be used. Long acting opioids will be avoided. Once anesthesia is instituted prior to prepping and draping a timeout will be called during which patient will be identified and procedures to be performed will be identified.

Procedures The patient will be kept in supine position with ipsilateral arm in abducted position. The skin overlying the ipsilateral breast and adjoining infraclavicular and axillary regions will be disinfected with chloraprep and sterile draping of the area is performed. A linear ultrasound probe of high frequency (6-13 MHz) of a portable ultrasound system (Sonosite, Micromaxx Bothell, Washington USA) is taken. The probe will be covered with a sterile transparent dressing and a sterile conductivity gel will be applied. The imaging depth on the ultrasound screen is set to 4-6 cm. The ultrasound probe will first be placed cephalocaudally in the infraclavicular region and moved laterally to locate vessels directly above the 1st rib. With further lateral and downward movements the 3rd and 4th ribs will be identified. The probe is maneuvered and appropriate anatomical structures including pectoralis major and minor muscles and serratus anterior muscle are identified.

The interface between pectoralis major, pectoralis minor and serratus anterior are identified. A spinal needle 20 gauge and 4 inches in length will be used to instill 10 cc of 0.2% Marcaine between serratus anterior and pectoralis minor. Aspiration is continuously used to confirm that there is no intravenous or intra-arterial injection of local anesthesia. The needle will then be withdrawn slightly, and 10 cc of 0.25% Marcaine is injected between pectoralis major and pectoralis minor under direct ultrasound visualization. Attention is then turned to the axilla of the operative side. A spinal needle under direct visualization is used to deliver 10 cc of 0.25% Marcaine between latissimus dorsi and serratus anterior. The PECS block is finished, and the rest of the procedure is performed according to surgeon discretion. All patients whether or not they receive the PECS block will receive 10 cc of 0.25% Marcaine subcutaneously at incision site.

Being tested
Pectoral Nerve Block, Surgery without Nerve Block
Keywords
Pain, Narcotics, Nerve block
Medical subject headings
Breast Neoplasms, Pain, Postoperative, Pain

What participants receive

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

  • Pectoral Nerve BlockProcedure or surgery

    Patients who were given 20 cc of 0.25% Marcaine as part of the pectoralis nerve block

  • Surgery without Nerve BlockProcedure or surgery

    Patient's underwent indicated procedure without regional pectoralis nerve block

Study groups in NCT04086394
Study groupRoleWhat they receive
PECS BlockExperimentalGroup who was randomly selected to receive the intraoperative nerve block.
Receives: Procedure: Pectoral Nerve Block
ControlSham comparatorPatient who was randomly selected not to receive intraoperative nerve block
Receives: Procedure: Surgery without Nerve Block

What is being measured

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

  1. Postoperative pain

    Visual Analogue Pain scores scaled from 1-10 with 1 being no pain and 10 being worst pain of one's life. This scale is used to assess postoperative pain. Scores will be compared between the two groups.

    Measured: Immediately postoperatively until day 3

Secondary outcomes (1)
  1. Postoperative Narcotic Use

    Amount of pain medication in morphine equivalents used after surgery until day 3

    Measured: 72 hours

Timeline

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

  1. First posted11 Sep 2019
  2. Study start1 Sep 2019
  3. Primary completion1 Sep 2020 (estimated)
  4. Study completion1 Nov 2020 (estimated)

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04086394
Sponsor's protocol ID
R20-3896L
Acronym
PECS
Status last verified
Feb 2020
First submitted
10 Sep 2019
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

    PubMed 25376971
  • Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.

    PubMed 21831090
  • Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.

    PubMed 27543533
  • Kumar S, Goel D, Sharma SK, Ahmad S, Dwivedi P, Deo N, Rani R. A randomised controlled study of the post-operative analgesic efficacy of ultrasound-guided pectoral nerve block in the first 24 h after modified radical mastectomy. Indian J Anaesth. 2018 Jun;62(6):436-442. doi: 10.4103/ija.IJA_523_17.

    PubMed 29962525
  • Zhao J, Han F, Yang Y, Li H, Li Z. Pectoral nerve block in anesthesia for modified radical mastectomy: A meta-analysis based on randomized controlled trials. Medicine (Baltimore). 2019 May;98(18):e15423. doi: 10.1097/MD.0000000000015423.

    PubMed 31045802
  • Senapathi TGA, Widnyana IMG, Aribawa IGNM, Jaya AAGPS, Junaedi IMD. Combined ultrasound-guided Pecs II block and general anesthesia are effective for reducing pain from modified radical mastectomy. J Pain Res. 2019 Apr 26;12:1353-1358. doi: 10.2147/JPR.S197669. eCollection 2019.

    PubMed 31114311
  • Versyck B, van Geffen GJ, Chin KJ. Analgesic efficacy of the Pecs II block: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):663-673. doi: 10.1111/anae.14607.

    PubMed 30957884

Questions about this trial

What is this clinical trial studying?

A study testing Pectoral Nerve Block and Surgery without Nerve Block in people with Breast Cancer and Postoperative Pain, run by Main Line Health 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Feb 2020. 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Kaitlyn Kennard, MD (610-642-1908, kennardk@mlhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain (time frame: Immediately postoperatively until day 3). 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 NCT04086394, which also lists 7 linked publications.

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 20 Feb 2020; AzTrials last refreshed its copy on 30 Oct 2026.

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