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Video Assisted Thoracic SurgeryEarly Phase 1NCT03731221

Pectoral Fascial Plane and Serratus Anterior Plane Blocks With Bupivacaine v. Liposomal Bupivacaine

A Early Phase 1 study testing Bupi HCI and lipo bupi and Bupi HCI in people with Video Assisted Thoracic Surgery, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients will be randomized the day of surgery upon presentation to the operating room to either a treatment group (PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine) or a control group (PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline) using secure web-based randomization. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Video Assisted Thoracic Surgery
What is being tested?
Bupi HCI and lipo bupi and Bupi HCI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteUnited States
Study dates
1 Nov 2018to 19 Sep 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients 18-85 years of age
  • Procedures using thoracic access ports or miniature thoracotomy incisions such as video assisted thoracic surgical (VATS) or robotic anatomic pulmonary resection (lobectomy, bilobectomy, and segmentectomy)

Who cannot join

  • Weight less than 50 kg
  • Pregnancy or lactation
  • Emergency surgery and patients transferred from the ICU to the operating room
  • Redo thoracic 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
  • Non-study nerve block that provides analgesia to the intercostal nerves
Show all 16Show fewer
  • Active systemic or cardiopulmonary infection
  • Mechanical circulatory support devices
  • Allergy or contraindication to study local anesthetics
  • More than 15 mg/day morphine equivalents on at least 15 of the 30 preoperative days
  • Poorly controlled psychiatric disorders
  • Clinically important current neurologic deficit e.g. spinal cord injury, paralysis of extremity, any neurologic deficit in the region of the block
  • Active liver disease or cirrhosis
  • Pacemaker generator or breast implants ipsilateral to surgery
  • Previous participation in this study
  • eGFR <30 or chronic kidney disease

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: A Comparison of Combined Pectoral Fascial Plane and Serratus Anterior Plane Blocks With Bupivacaine HCL With and Without Liposomal Bupivacaine for Video Assisted Thoracic Surgery

Patients will be randomized the day of surgery upon presentation to the operating room to either a treatment group (PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine) or a control group (PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline) using secure web-based randomization. Assignments will be based on computer-generated code. Clinicians will not be blinded to the intervention, but all outcomes will be assessed by research personnel who are blinded to the group assignment.

Read the detailed description

Anesthetic care will be performed in a usual manner in Cleveland Clinic thoracic surgical patients. This includes the use of standard ASA monitors and may include the use of arterial or central venous pressure monitoring, trans-esophageal echocardiography, and lung isolation using a bronchial blocker or a double lumen endotracheal tube. Medication administration for induction and maintenance of anesthesia will also be consistent with usual care and will include intravenous opioids such as fentanyl and hydromorphone. Intravenous lidocaine boluses will not be administered upon induction of anesthesia. Pressure control ventilation will be utilized with a tidal volume not exceeding 6-10 ml/kg ideal body weight during two-lung ventilation and 5-7 ml/kg ideal body weight during one-lung ventilation. A conservative fluid management strategy will be employed in all cases. Patients not extubated at the end of the procedure will be sedated with propofol. Surgical procedures will be performed in their usual manner.

The anatomic basis for chest wall analgesia has been described in detail previously. The investigators describe the conduct of the blocks as used for VATS procedures at the investigator's institution. The patients randomized to the treatment group will all receive PECSII and serratus blocks containing bupivacaine HCl and liposomal bupivacaine. The control group will receive PECSII and serratus blocks with bupivacaine HCl adjusted to a similar volume. The PECS/serratus blocks will be performed with the patient under the general anesthesia and before incision. If this is not possible due to surgical urgency, the block will be placed at end of surgery.

Patients will be positioned supine, and prepped and draped in a sterile fashion. An ultrasound probe will be placed just below the clavicle in the mid-clavicular line.

For the PECS II block, the probe will be scanned inferiorly and laterally until the plane between the pectoralis minor and serratus muscle is identified. The serratus muscle can be clearly seen coursing over the ribs, while the intercostal muscles are seen in the interspaces between the ribs. Once the plane is identified the needle is again advanced in an "in-plane" fashion. Once the needle location is confirmed by normal saline hydro-dissection, a 15-20 cc of local anesthetic solution is administered into the space.

With the patient in a supine position, a back roll will be placed under the operative side to achieve a slightly lateral tilt. The arm is abducted to expose the costal margin. The positioning and prepping is done prior to the PECS block to avoid repositioning. The ultrasound probe is scanned laterally from the pectoralis to the axillary region at approximately the level of the 5th rib. The plane between the serratus muscle and the latissimus dorsi muscle is identified and the needle advanced in an "in-plane" fashion until the tip is between the muscles (superficial SAP block). A small bolus of 0.5 cc of normal saline is used for hydro-dissection of the tissue planes to confirm that the needle is not intramuscular. The needle is then aspirated every 5 cc as 40 cc of local anesthetic solution is deposited into the plane. As these are field blocks, adequate volume of infiltration is important in achieving optimal analgesia.

The LA used for the 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. Typically the block has duration of action of less than 12 hours after infiltration.34 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.35 Control patients will have preservative free normal saline mixed with 0.5% bupivacaine HCL and all patients will have a total block solution volume of 60 ml.

Liposomal bupivacaine dosing is not weight based and the full 266-mg bottle can be administered to adult thoracic patients. A maximum of 150mg bupivacaine HCl can be mixed with Exparel. This equates to one 30-mL bottle of 0.5% bupivacaine HCl or two (2) bottles of 0.25% bupivacaine HCl. If a higher volume of the LA is needed a 10 ml of normal saline can be added to the mixture of bupivacaine HCL and liposomal bupivacaine. Thus patients ≥60 kg will receive 150 mg of bupivacaine HCL, while patients weighing <60 kg need to have the bupivacaine dose calculated but can still receive full 20 ml of Exparel.

Being tested
Bupi HCI and lipo bupi, Bupi HCI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupi HCI and lipo bupiDrug

    Also called Bupi and lipo bupi

    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.

  • Bupi HCIDrug

    Also called Control

    The LA used for the 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. Control patients will have preservative free normal saline mixed with 0.5% bupivacaine HCL and all patients will have a total block solution volume of 60 ml.

Study groups in NCT03731221
Study groupRoleWhat they receive
Bupi HCl plus liposomal bupiExperimentalPECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine
Receives: Drug: Bupi HCI and lipo bupi
Bupi HCl plus salineActive comparatorPECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline
Receives: Drug: Bupi HCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall benefit of analgesia score

    The overall benefit of analgesia score (OBAS) is based on 7 questions and ranges from 0 to 28 points

    Measured: Postoperative day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2018
  2. Study start1 Nov 2018
  3. Primary completion19 Sep 2024
  4. Study completion19 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized the day of surgery upon presentation to the operating room to either a treatment group (PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine) or a control group (PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline) using secure web-based randomization.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03731221
Sponsor's protocol ID
18-981
Status last verified
Jun 2025
First submitted
22 Oct 2018
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD will be shared on a collaborative basis.

Publications

  • Marciniak D, Raymond D, Alfirevic A, Yalcin EK, Bakal O, Pu X, Kelava M, Duncan A, Hargrave J, Bauer A, Bustamante S, Lam L, Murthy S, Sessler DI, Turan A. Combined pectoralis and serratus anterior plane blocks with or without liposomal bupivacaine for minimally invasive thoracic surgery: A randomized clinical trial. J Clin Anesth. 2024 Oct;97:111550. doi: 10.1016/j.jclinane.2024.111550. Epub 2024 Jul 18.

    PubMed 39029153

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Bupi HCI and lipo bupi and Bupi HCI in people with Video Assisted Thoracic Surgery, 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 16 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 10 Jun 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of analgesia score (time frame: Postoperative day 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 NCT03731221, 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 10 Jun 2025.

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