Pectoralis and Serratus Muscle Blocks

NCT03743194 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-1125
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The overall research plan is PECS/SAP blocks with liposomal bupivacaine improve the Overall Benefit Analgesia Score averaged over the postoperative days 1, 2, and 3. A 20% reduction on geometric means (i.e., true ratio of geometric means of 0.80) in OBAS will be considered the minimal clinically important benefit.

Conditions

Post Operative Pain Control

Outcome Measures

Primary Outcomes (1)

• Overall Benefit Analgesia Score

  Our primary outcome, Overall Benefit Analgesia Score (OBAS), was measured daily by investigators blinded to treatment on postoperative Days 1 to 3.Potential scores of the seven-item questionnaire ranged from 0 to 28 points. Higher scores means worse conditions.

  Postoperative day 1-3

Secondary Outcomes (4)

• Cumulative Opioid Consumption Over Postoperative 3 Days

  72 hours postoperative

• Postoperative FEV1

  Postoperatively day 1 -3

• Postoperative FVC

  Postoperative day 1 -3

• Postoperative Peak Flow

  Postoperative day 1-3

Study Arms (2)

Bupi HCl plus liposomal bupi

ACTIVE COMPARATOR

Pectoral fascial plane or serratus anterior plane blocks (PECSII/SAP blocks) with bupivacaine HCl plus liposomal bupivacaine. An ultrasound guided pectoral fascial plane blocks (PECS I and II blocks) and Serratus anterior plane (SAP) block with injection of the local anesthetic.

Drug: Exparel 266 MG Per 20 ML Injection; Drug: Placebo

Control Group

PLACEBO COMPARATOR

Standard parenteral analgesia technique with or without incisional local anesthetic infiltration: patients randomized to control group will be given parenteral opioids (such as fentanyl or hydromorphone) until they are converted to the enteral medications such as Percocet.

Drug: Placebo

Interventions

Exparel 266 MG Per 20 ML Injection DRUG

The local anesthetic (LA) used for the PECS II or serratus plane blocks will be a 0.5% bupivacaine HCL, not to exceed 2.5mg/kg or up to 150mg. The LA solution can be diluted with preservative free normal saline for smaller patients to allow for appropriate volume of injection. Treatment patients will also be given liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc. San Diego, CA) in a dose of 266 mg in 20 ml can be safely combined with bupivacaine HCL at a ratio not exceeding 2:1, but cannot be combined with other local anesthetics due to the concern of rapid release of encapsulated bupivacaine and subsequent local anesthetic toxicity.

Also known as: Pectoralis and Serratus Muscle Blocks

Bupi HCl plus liposomal bupi

Placebo DRUG

Patients randomized to standard analgesia technique will be given pain medications.

Also known as: Standard analgesia technique (control, NO PECS /SAP blocks)

Bupi HCl plus liposomal bupi; Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• Elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy

You may not qualify if:

• Weight less than 50 kg;
• Pregnancy or lactation;
• Emergency surgery and patients transferred from the ICU to the operating room;
• Redo cardiothoracic surgery or post-operative reoperation within 72 hours of index procedure (including minor chest wall procedures including tube thoracostomy, thoracentesis or percutaneous drain placement);
• Anticipated endotracheal intubation \> 24 hours;
• Anticipated non-study nerve block that provides analgesia to the intercostal nerves;
• Active systemic or cardiopulmonary infection;
• Mechanical circulatory support;
• Allergy or contraindication to study local anesthetics;
• Current chronic pain or routine opioid use (patients on chronic enteral opioids like Percocet or Vicodin) in a dose of \> 30 mg of morphine-milligram-equivalents for at least 10 days in last 30 days;
• Poorly controlled psychiatric disorders;
• Clinically important current neurologic deficit;
• Active liver disease or cirrhosis;
• Pacemaker generator or breast implants ipsilateral to surgery;
• Previous participation in this study.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Alfirevic A, Marciniak D, Duncan AE, Kelava M, Yalcin EK, Hamadnalla H, Pu X, Sessler DI, Bauer A, Hargrave J, Bustamante S, Gillinov M, Wierup P, Burns DJP, Lam L, Turan A. Serratus anterior and pectoralis plane blocks for robotically assisted mitral valve repair: a randomised clinical trial. Br J Anaesth. 2023 Jun;130(6):786-794. doi: 10.1016/j.bja.2023.02.038. Epub 2023 Apr 11.

  PMID: 37055276 DERIVED

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Xuan Pu
• Organization: The Cleveland Clinic Foundation

PuX@ccf.org

216 444-8013

Study Officials

• Andrej Alfirevic, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 16, 2018
• Study Start: December 14, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 14, 2022
• Last Updated: October 23, 2025
• Results First Posted: December 29, 2023

Record last verified: 2025-09

Locations

US (1)