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CompletedNCT03743194Updated Oct 23, 2025Results posted

Pectoralis and Serratus Muscle Blocks

A Phase 4 interventional study of Exparel 266 MG Per 20 ML Injection and Placebo in Post Operative Pain Control, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-10-23.

Sponsored by The Cleveland Clinic · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Post Operative Pain Control
03

In context

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 18-85 years old;
  2. Elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy

Exclusion criteria

Exclusion Criteria:

  1. Weight less than 50 kg;
  2. Pregnancy or lactation;
  3. Emergency surgery and patients transferred from the ICU to the operating room;
  4. 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);
  5. Anticipated endotracheal intubation > 24 hours;
  6. Anticipated non-study nerve block that provides analgesia to the intercostal nerves;
  7. Active systemic or cardiopulmonary infection;
  8. Mechanical circulatory support;
  9. Allergy or contraindication to study local anesthetics;
  10. 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;
  11. Poorly controlled psychiatric disorders;
  12. Clinically important current neurologic deficit;
  13. Active liver disease or cirrhosis;
  14. Pacemaker generator or breast implants ipsilateral to surgery;
  15. Previous participation in this study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
210 participants (actual)

Study arms

  • Active comparator
    Bupi HCl plus liposomal bupi

    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

  • Placebo comparator
    Control Group

    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

  • DrugExparel 266 MG Per 20 ML Injection

    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

  • DrugPlacebo

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

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

06

What researchers measure

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.

    Time frame: Postoperative day 1-3

Secondary outcomes

  1. Cumulative Opioid Consumption Over Postoperative 3 Days

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

    Time frame: 72 hours postoperative

  2. Postoperative FEV1

    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.

    Time frame: Postoperatively day 1 -3

  3. Postoperative FVC

    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.

    Time frame: Postoperative day 1 -3

  4. Postoperative Peak Flow

    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.

    Time frame: Postoperative day 1-3

07

Results

Posted Dec 29, 2023

Participant flow

Participant flow — Overall Study
MilestoneBupivacaine HCl plus liposomal bupivacaineControl Group
Started105105
Completed9896
Not completed79
Withdrew: Protocol violation77
Withdrew: Physician decision20

Outcome measures

PrimaryOverall 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.

Time frame:
Postoperative day 1-3
Reported as:
Median · score on a scale
Overall Benefit Analgesia Score
score on a scaleBupivacaine HCl plus liposomal bupivacaineControl Group
POD 14 (2 to 7)5 (2 to 6)
POD 23 (2 to 6)3 (2 to 5)
POD 32 (1 to 4)2 (1 to 4)
Statistical analysis
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Linear mixed model · p = 0.75 · Geometric mean ratio: 0.98 · 95% CI 0.85 to 1.13
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · linear mixed model · p = 0.71 · Geometric mean ratio: 0.97 · 95% CI 0.83 to 1.14
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Wilcoxon (Mann-Whitney) · p = 0.69 · Median difference (final values): 0.08 · 95% CI -0.5 to 0.67
SecondaryCumulative Opioid Consumption Over Postoperative 3 Days

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

Time frame:
72 hours postoperative
Reported as:
Median · mg morphine equivalents
Cumulative Opioid Consumption Over Postoperative 3 Days
mg morphine equivalentsBupivacaine HCl plus liposomal bupivacaineControl Group
Cumulative Opioid Consumption Over Postoperative 3 Days118 (53 to 190)113 (53 to 188)
Statistical analysis
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Regression, Linear · p = 0.94 · Geometric mean ratio: 1.01 · 98.75% CI 0.73 to 1.40
SecondaryPostoperative FEV1

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.

Time frame:
Postoperatively day 1 -3
Reported as:
Mean · L
Postoperative FEV1
LBupivacaine HCl plus liposomal bupivacaineControl Group
POD11.3 ± 0.41.3 ± 0.4
POD21.4 ± 0.61.4 ± 0.5
POD31.6 ± 0.61.6 ± 0.6
Statistical analysis
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Linear mixed model · p = 0.36 · Mean difference (final values): 0.08 · 99.6% CI -0.17 to 0.32
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Linear mixed model · p = 0.79 · Mean difference (final values): -0.02 · 99.6% CI -0.26 to 0.22
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Linear mixed model · p = 0.39 · Mean difference (final values): -0.07 · 99.6% CI -0.31 to 0.17
SecondaryPostoperative FVC

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.

Time frame:
Postoperative day 1 -3
Reported as:
Mean · L
Postoperative FVC
LBupivacaine HCl plus liposomal bupivacaineControl Group
POD11.7 ± 0.61.7 ± 0.6
POD21.8 ± 0.81.9 ± 0.7
POD32.1 ± 0.82.2 ± 0.8
Statistical analysis
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Linear mixed model · p = 0.51 · Mean difference (final values): 0.07 · 99.6% CI -0.25 to 0.4
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Linear mixed model · p = 0.91 (Mean difference at POD2) · Mean difference (final values): -0.01 · 99.6% CI -0.33 to 0.30
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Linear mixed model · p = 0.31 · Mean difference (final values): -0.11 · 99.6% CI -0.43 to 0.21
SecondaryPostoperative Peak Flow

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.

Time frame:
Postoperative day 1-3
Reported as:
Mean · L/s
Postoperative Peak Flow
L/sBupivacaine HCl plus liposomal bupivacaineControl Group
POD13.1 ± 1.53.0 ± 1.2
POD23.2 ± 1.53.2 ± 1.3
POD33.4 ± 1.73.6 ± 1.7
Statistical analysis
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Linear mixed model · p = 0.36 · Mean difference (final values): 0.22 · 99.6% CI -0.47 to 0.91
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Linear mixed model · p = 0.97 · Mean difference (final values): 0.01 · 99.6% CI -0.66 to 0.67
  • Bupivacaine HCl plus liposomal bupivacaine vs Control Group · Linear mixed model · p = 0.36 · Mean difference (final values): -0.21 · 99.6% CI -0.88 to 0.46

Adverse events

Collected over 90 days. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bupivacaine HCl plus liposomal bupivacaine0/98 (0%)0/98 (0%)0/98 (0%)
Control Group0/96 (0%)0/96 (0%)0/96 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Bupivacaine HCl plus liposomal bupivacaineControl GroupTotal
Mean57 ± 1056 ± 1157 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)Bupivacaine HCl plus liposomal bupivacaineControl GroupTotal
Female241640
Male7480154
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Bupivacaine HCl plus liposomal bupivacaineControl GroupTotal
American Indian or Alaska Native000
Asian336
Native Hawaiian or Other Pacific Islander000
Black or African American112
White9288180
More than one race213
Unknown or Not Reported033
ASA status
ASA status(Participants)Bupivacaine HCl plus liposomal bupivacaineControl GroupTotal
III7979158
IV191736
Smoking status
Smoking status(Participants)Bupivacaine HCl plus liposomal bupivacaineControl GroupTotal
Yes235
No7778155
Former191534
Coronary arterial disease
Coronary arterial disease(Participants)Bupivacaine HCl plus liposomal bupivacaineControl GroupTotal
Count of participants639
Hypertension
Hypertension(Participants)Bupivacaine HCl plus liposomal bupivacaineControl GroupTotal
Count of participants312758
Previous myocardial infarction
Previous myocardial infarction(Participants)Bupivacaine HCl plus liposomal bupivacaineControl GroupTotal
Count of participants202

8 further baseline measures are reported on the registry.

08

Study locations

1 site
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
09

References and documents

Publications

  • 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. PubMed 37055276 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 6, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03743194
Lead sponsor
The Cleveland Clinic
Responsible party
Sponsor
First posted
Nov 16, 2018
Start date
Dec 14, 2021
Primary completion
Feb 28, 2022
Completion
Mar 14, 2022
Results posted
Dec 29, 2023
Last update
Oct 23, 2025

Study contacts

Andrej Alfirevic, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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