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Pectoralis and Serratus Muscle Blocks

Primary Purpose

Post Operative Pain Control

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel 266 MG Per 20 ML Injection
Placebo
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain Control

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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.

Sites / Locations

  • The Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupi HCl plus liposomal bupi

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall Benefit Analgesia Score
The OBAS score will be used to validated postoperatively calculated, multi-dimensional questionnaire that consists of 7 items encompassing not only scale-rated pain score but different aspects of analgesia benefits, side effects and overall patient's satisfaction. The average for postoperative day 1, 2 and 3 will be calculated.

Secondary Outcome Measures

Postoperative opioid consumption
Cumulative 72-hour postoperative opioid consumption (mg IV morphine equivalents)
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.
Postoperative pain score
Average 72-hour postoperative pain score, measured by 0-10 verbal response scale and evaluated, per routine, by the nursing staff every four hours while patients remain hospitalized
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.
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.

Full Information

First Posted
October 31, 2018
Last Updated
February 1, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03743194
Brief Title
Pectoralis and Serratus Muscle Blocks
Official Title
Pectoralis and Serratus Muscle Blocks for Analgesia After Minimally Invasive Cardiac Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupi HCl plus liposomal bupi
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Exparel 266 MG Per 20 ML Injection
Other Intervention Name(s)
Pectoralis and Serratus Muscle Blocks
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Standard analgesia technique (control, NO PECS /SAP blocks)
Intervention Description
Patients randomized to standard analgesia technique will be given pain medications.
Primary Outcome Measure Information:
Title
Overall Benefit Analgesia Score
Description
The OBAS score will be used to validated postoperatively calculated, multi-dimensional questionnaire that consists of 7 items encompassing not only scale-rated pain score but different aspects of analgesia benefits, side effects and overall patient's satisfaction. The average for postoperative day 1, 2 and 3 will be calculated.
Time Frame
Postoperative day 3
Secondary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Cumulative 72-hour postoperative opioid consumption (mg IV morphine equivalents)
Time Frame
72 hours postoperative
Title
Postoperative FEV1
Description
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 morning 3
Title
Postoperative pain score
Description
Average 72-hour postoperative pain score, measured by 0-10 verbal response scale and evaluated, per routine, by the nursing staff every four hours while patients remain hospitalized
Time Frame
72 hours postoperative
Title
Postoperative FVC
Description
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
Postoperatively morning 3
Title
Postoperative peak flow
Description
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
Postoperatively morning 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Pectoralis and Serratus Muscle Blocks

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