Post Operative Pain ControlPhase 4NCT03743194
Pectoralis and Serratus Muscle Blocks
A Phase 4 study testing Exparel 266 MG Per 20 ML Injection in people with Post Operative Pain Control, run by The Cleveland Clinic at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post Operative Pain Control
- What is being tested?
- Exparel 266 MG Per 20 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 14 Mar 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 years old;
- Elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
Official title: Pectoralis and Serratus Muscle Blocks for Analgesia After Minimally Invasive Cardiac Procedures
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.
- Conditions
- Post Operative Pain Control
- Being tested
- Exparel 266 MG Per 20 ML Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel 266 MG Per 20 ML InjectionDrug
Also called Pectoralis and Serratus Muscle Blocks
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.
PlaceboDrug
Also called Standard analgesia technique (control, NO PECS /SAP blocks)
Patients randomized to standard analgesia technique will be given pain medications.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 1-3
Secondary outcomes (4)
Cumulative Opioid Consumption Over Postoperative 3 Days
Cumulative 72-hour postoperative opioid consumption (mg IV morphine equivalents)
Measured: 72 hours postoperative
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.
Measured: Postoperatively day 1 -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.
Measured: Postoperative day 1 -3
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.
Measured: Postoperative day 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start14 Dec 2021
- Primary completion28 Feb 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pain ControlStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrej Alfirevic, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743194
- Sponsor's protocol ID
- 18-1125
- Status last verified
- Sep 2025
- First submitted
- 31 Oct 2018
- Last updated
- 23 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pectoralis and Serratus Muscle Blocks for Analgesia After Minimally Invasive Cardiac Procedures
- ClinicalTrials.gov ID
- NCT03743194
- Acronym / sponsor ID
- 18-1125
- Conditions
- Post Operative Pain Control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Posted 29 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupi HCl plus liposomal bupi | Active comparator | Drug: Exparel 266 MG Per 20 ML Injection, Drug: PlaceboPectoral 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. |
| Control Group | Placebo comparator | Drug: PlaceboStandard 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-85 years old;
- Elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exparel 266 MG Per 20 ML InjectionAlso: Pectoralis and Serratus Muscle BlocksThe 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. | Drug | Bupi HCl plus liposomal bupi |
| PlaceboAlso: Standard analgesia technique (control, NO PECS /SAP blocks)Patients randomized to standard analgesia technique will be given pain medications. | Drug | Bupi HCl plus liposomal bupi, Control Group |
Primary outcome
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.
4 secondary outcomes
Cumulative Opioid Consumption Over Postoperative 3 Days
Time frame: 72 hours postoperative
Postoperative FEV1
Time frame: Postoperatively day 1 -3
Postoperative FVC
Time frame: Postoperative day 1 -3
Postoperative Peak Flow
Time frame: Postoperative day 1-3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37055276Alfirevic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Alfirevic, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exparel 266 MG Per 20 ML Injection in people with Post Operative Pain Control, run by The Cleveland Clinic 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 2 inclusion and 15 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: finished, as of the sponsor's last update on 23 Oct 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Benefit Analgesia Score (time frame: Postoperative day 1-3). 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 NCT03743194, which also lists 1 linked publication.
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 23 Oct 2025.