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

NCT03731221 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 18-981
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Video Assisted Thoracic Surgery

Outcome Measures

Primary Outcomes (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

  Postoperative day 3

Study Arms (2)

Bupi HCl plus liposomal bupi

EXPERIMENTAL

PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine

Drug: Bupi HCI and lipo bupi

Bupi HCl plus saline

ACTIVE COMPARATOR

PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline

Drug: Bupi HCI

Interventions

Bupi HCI and lipo bupi 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: Bupi and lipo bupi

Bupi HCl plus liposomal bupi

Bupi HCI DRUG

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.

Also known as: Control

Bupi HCl plus saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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 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
• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Alparslan Turan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Anesthesiologists will not be blinded to the intervention, but all outcomes will be assessed by research personnel who are blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Enterprise Chair, Dept of Intensive Care and Resuscitation

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 6, 2018
• Study Start: November 1, 2018
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of main paper.
• Access Criteria: IPD will be shared on a collaborative basis.

Locations

US (1)