The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-22

Study Completion Date

2025-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery. The hypothesis is that this analgesic delivery method will significantly reduce negative outcomes such as post-operative pain, opioid use, and nausea while increasing positive outcomes such as post-operative physical activity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pecto-Intercostal Fascial Plane Block Study

NCT04928339

Cardiac Surgery Opioid Use, Unspecified

COMPLETED PHASE4

PECS I Block for Breast Subpectoral Implant Surgery

NCT02849236

Pain, Postoperative

COMPLETED NA

Is PECS Block Equivalent to Paravertebral Block in Preventing Postoperative Pain After Breast Surgery?

NCT02645474

Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction

NCT02525718

Breast Cancer

COMPLETED PHASE2

Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery

NCT03383198

Pain, Postoperative

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The research team will be investigating the use of a novel type of local drug administration as well as assessing whether a non-opioid based drug will result in more positive pain outcomes while reducing reliance on narcotics (opioid-based drugs) following surgery.

The drug administration tool, called the Pecs blocks types I and II, utilizes ultrasound to help guide anesthetic injection for local anesthesia. This has been an effective way to deliver local anesthetic during breast surgeries. Meanwhile, a non-opioid analgesic drug (similar to an anesthetic, meaning it is used during surgery to reduce pain) called Exparel has been shown to reduce post-operative use of narcotics, length of stay in hospitals, and pain compared to the current standards in breast reconstruction surgery. Exparel is approved by the FDA for use in surgical sites during breast reconstruction surgery. Exparel has shown to reduce pain and post-surgical nausea and vomiting in breast reconstruction patients. However, the combination of Exparel with Pecs blocks has not been examined in breast reconstruction surgery, and the research team suspects that breast reconstruction patients who are administered Exparel with Pecs blocks will experience less pain, increased mobility, and less nausea following surgery. Furthermore, the researchers believe that this non-opioid based drug could reduce the necessity to use narcotics following surgery. Narcotics are highly addictive and can lead to dependency following surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mammaplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. Group 1: Use of Pecs block types I and II with bupivacaine as local anesthetic
2. Group 2: Use of Pecs block types I and II with mixture of bupivacaine and Exparel\* (\*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel and in ability to use lidocaine infusion with injection of Exparel)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patient will be randomized into one of the two trial arms. Randomization process will involve 60 envelopes, 30 of which will contain assignment to the study arm with Exparel blocks and 30 which will contain assignment to bupivacaine blocks. The PI's attending nurse will randomly distribute an envelope to the study team between V1 and V2. V2, the day of surgery, will be the only visit where the patient would potentially have contact with the treatments. The patient will not be aware of what treatment they receive until after their 2-week follow-up.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Blocks+Bupivacaine

Use of Pecs block types I and II with bupivacaine as local anesthetic

Group Type ACTIVE_COMPARATOR

Pecs blocks

Intervention Type DEVICE

Pectoral nerve (Pecs) blocks I and II function by blocking the pectoral, intercostal, intercostobrachial nerves, and/or long thoracic nerve. These are used primarily for breast surgeries and are gaining momentum as simple administers of local analgesics. Pecs blocks utilize ultrasound to guide injection of local analgesic. It is less invasive and more accurate than most current modes of analgesia administration.

Bupivacaine

Intervention Type DRUG

This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in both arms.

Breast Reconstruction (Mammaplasty)

Intervention Type PROCEDURE

Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander

Blocks+Bupivacaine+Exparel

Use of Pecs block types I and II with mixture of bupivacaine and Exparel\* (\*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel)

Group Type EXPERIMENTAL

Pecs blocks

Intervention Type DEVICE

Pectoral nerve (Pecs) blocks I and II function by blocking the pectoral, intercostal, intercostobrachial nerves, and/or long thoracic nerve. These are used primarily for breast surgeries and are gaining momentum as simple administers of local analgesics. Pecs blocks utilize ultrasound to guide injection of local analgesic. It is less invasive and more accurate than most current modes of analgesia administration.

Exparel

Intervention Type DRUG

Exparel is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension of multivesicular liposomes (DepoFoam® drug delivery system) containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of Exparel, bupivacaine is released from the multivesicular liposomes over a period of time.

Bupivacaine

Intervention Type DRUG

This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in both arms.

Breast Reconstruction (Mammaplasty)

Intervention Type PROCEDURE

Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pecs blocks

Pectoral nerve (Pecs) blocks I and II function by blocking the pectoral, intercostal, intercostobrachial nerves, and/or long thoracic nerve. These are used primarily for breast surgeries and are gaining momentum as simple administers of local analgesics. Pecs blocks utilize ultrasound to guide injection of local analgesic. It is less invasive and more accurate than most current modes of analgesia administration.

Intervention Type DEVICE

Exparel

Exparel is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension of multivesicular liposomes (DepoFoam® drug delivery system) containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of Exparel, bupivacaine is released from the multivesicular liposomes over a period of time.

Intervention Type DRUG

Bupivacaine

This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in both arms.

Intervention Type DRUG

Breast Reconstruction (Mammaplasty)

Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pecs blocks I and II

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subjects greater than 18 years of age.
2. Subject who are undergoing implant-based, tissue expander breast reconstruction surgery.

Exclusion Criteria

1. Subjects undergoing flap breast reconstruction.
2. Subjects who are undergoing direct-to-implant surgery.
3. Subjects who have previously undergone radiation therapy.
4. Medical or psychiatric condition that may increase the risk associated with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
5. Subjects who are pregnant at the date of surgery.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes