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Completed

NCT Number: NCT03743194

Pectoralis and Serratus Muscle Blocks

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

The primary aim is to determine whether a PECS/SAP block, using a mixture of bupivacaine and liposomal bupivacaine, provides superior recovery compared to routine parenteral and enteral analgesia in patients recovering from MICS. The primary outcome will be the simple multi-dimensional quality assessment, Overall Benefit Analgesia Score (OBAS score).53 Our secondary aims are to: 1) compare cumulative postoperative opioid consumption (pain medications administered over one-day periods quantified as morphine equivalents and provided by the EMR for the day of surgery and postoperative days 1, 2, and 3; 2) evaluate respiratory mechanics (forced expiratory volume in first minute (FEV1), forced vital capacity (FVC) and peak flow) after extubation on the postoperative days 1, 2 and 3 while patients remain hospitalized; and, (3) evaluate the Quality-of-Recovery-15 score on the postoperative days 1, 2 and 3.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-85 years old;
  • Elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Pectoralis and Serratus Muscle Blocks

Placebo

Drug

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

Other names: Standard analgesia technique (control, NO PECS /SAP blocks)

Primary outcomes

  1. Overall Benefit Analgesia Score

    Time frame: Postoperative day 1-3

    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.

Secondary outcomes

  1. Cumulative Opioid Consumption Over Postoperative 3 Days

    Time frame: 72 hours postoperative

    Cumulative 72-hour postoperative opioid consumption (mg IV morphine equivalents)

  2. Postoperative FEV1

    Time frame: Postoperatively day 1 -3

    Pulmonary Mechanics measure: The FEV1 (forced expiratory volume in 1 seconds) in litters, measured using Easy on-PC Spirometry System (ndd Medical, Andover MA) with the patient in the sitting position. Measurements will be done on postoperative mornings 1, 2 and 3. The average of 3 days measurement will be calculated.

  3. Postoperative FVC

    Time frame: Postoperative day 1 -3

    Pulmonary Mechanics measure: the FVC (Forced Vital Capacity) in litters will be measured using Easy on-PC Spirometry System (ndd Medical, Andover MA) with the patient in the sitting position. Measurements will be done on postoperative mornings 1, 2 and 3. The average of 3 days measurement will be calculated.

  4. Postoperative Peak Flow

    Time frame: Postoperative day 1-3

    Pulmonary Mechanics measure: the peak flow (peak expiratory flow) in litters per second will be measured using Easy on-PC Spirometry System (ndd Medical, Andover MA) with the patient in the sitting position. Measurements will be done on postoperative mornings 1, 2 and 3. The average of 3 days measurement will be calculated.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Pectoralis and Serratus Muscle Blocks for Analgesia After Minimally Invasive Cardiac Procedures

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 16, 2018
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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