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Serratus Anterior Plane Block With and Without Adjuvants in Video-assisted Thoracoscopy

Primary Purpose

Post Operative Pain, Acute

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine 0.25% Injectable Solution
Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg
Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg, Buprenorphine 300 mcg
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Operative Pain, Acute focused on measuring Serratus anterior plane block, video-assisted thoracoscopy, opioid consumption, magnesium, buprenorphine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients undergoing video-assisted thoracoscopy

Exclusion Criteria:

  • Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.)
  • Patients with significant platelet dysfunction
  • Infection at site for regional anesthesia
  • Allergy to local anesthetics
  • Sepsis

Sites / Locations

  • St. Joseph Mercy Oakland HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

SAPB

SAPB with Mg

SAPB with Mg and Buprenorphine

Arm Description

40 Patients - Patients will receive 30 mL of 0.25% bupivacaine injected below the serratus anterior muscle in the caudal direction using ultrasound guidance.

40 Patients - Patients will receive 30 mL of 0.25% bupivacaine with 150 mg of Mg injected below the serratus anterior muscle in the caudal direction using ultrasound guidance.

40 Patients - Patients will receive 30 mL of 0.25% bupivacaine with 150 mg of Mg and 300 mcg of buprenorphine injected below the serratus anterior muscle in the caudal direction using ultrasound guidance.

Outcomes

Primary Outcome Measures

Post-operative total opioid consumption (oral morphine equivalents)
Total Opioid consumption 24 hours post surgery oral moral morphine equivalents
Visual analog scale (VAS) pain scores
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Visual analog scale (VAS) pain scores
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Visual analog scale (VAS) pain scores
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)

Secondary Outcome Measures

Incidence of post-operation nausea and vomiting (PONV)
The percentage of the patients who had post-operative nausea and vomiting (PONV) within 24 hours of surgery
Acetaminophen consumption
Total acetaminophen consumption in mg
NSAID (ketorolac) consumption
Total NSAID consumption in mg

Full Information

First Posted
October 12, 2021
Last Updated
October 12, 2021
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT05090761
Brief Title
Serratus Anterior Plane Block With and Without Adjuvants in Video-assisted Thoracoscopy
Official Title
Is Serratus Anterior Plane Block (SAPB) With Adjuvant Medications Better at Managing Post-operative Pain Than Serratus Anterior Plane Block With Bupivacaine Alone in Patients Undergoing Video-assisted Thoracoscopy?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether the addition of the serratus anterior plane block (SAPB) alone (30 mL of 0.25% bupivacaine) or plus Magnesium (150 mg of magnesium sulfate) or plus Magnesium + Buprenorphine (300 mcg) as adjuvants can improve post-operative pain in patients undergoing video-assisted thoracoscopic surgery.
Detailed Description
Many thoracic surgeons have switched from open thoracotomy to video-assisted thoracoscopy (VATS), when possible, in efforts to decrease length of hospital stays, decrease analgesic requirements, and decrease postoperative pain. The serratus anterior plane block (SAPB) has been used effectively for the management of pain in the context of rib fractures, rib contusions, thoracoscopic surgery, thoracotomy, breast surgery, and post-mastectomy pain syndrome. It has been shown to have similar efficacy to thoracic epidurals in open thoracotomy. The serratus anterior muscle originates from the anterior aspect of ribs 1 through 7-10 and inserts on the medial border of the scapula. It consists of 7 to 10 serrated tendinous projections that originate on each rib and is innervated by the long thoracic nerve. Deep and superficial potential spaces bound the serratus anterior. At the level of the fifth rib, the superficial plane forms from the anterior aspect of the serratus anterior and the posterior aspect of the latissimus dorsi muscle. The deep plane forms from the posterior aspect of the serratus anterior and the external intercostal muscles and ribs. Injecting in either plane will achieve analgesia to the anterolateral chest wall with reportedly similar efficacy and an equivalent area of cutaneous sensory loss. The SAPB targets the lateral cutaneous branches of the thoracic intercostal nerves, which arise from the anterior rami of the thoracic spinal nerves and run in a neurovascular bundle immediately inferior to each rib. At the midaxillary line, the lateral cutaneous branches of the thoracic intercostal nerve traverse through the internal intercostal, external intercostal, and serratus anterior muscles innervating the musculature of the lateral thorax. These branches of the intercostal nerves, therefore, travel through the two potential spaces described above. Local anesthetic inserted into these planes will spread throughout the lateral chest wall, resulting in paresthesia of the T2 through T9 dermatomes of the anterolateral thorax. Rebound pain is possible after serratus anterior block because analgesia provided by bupivacaine typically lasts around six hours. Local anesthetic systemic toxicity is a potential complication of regional anesthesia as well. For this reason, dilute anesthetic is used, and a maximum dose of 2 mg/kg of bupivacaine is the recommendation. Pneumothorax is a potential complication but would entail catastrophic error because the fascial planes targeted in this block are superficial to the ribs, and the pleural line can be visualized clearly on ultrasound. If a pneumothorax is suspected, ultrasound can help to confirm lung sliding immediately after the procedure. Nerve injury is unlikely given the needle is not steered directly at nerves, but instead towards the plane through which the nerves run. The duration of traditional amide-based and ester-based regional anesthesia is normally limited to only a few hours as mentioned above. Techniques including continuous catheter placement or serial injections can be used to enhance the duration and effect of regional anesthesia for postoperative pain control. But these approaches can increase the risk of infection, toxicity, and cost. Therefore, alternative methods of extending the clinical duration of nerve blocks have been a topic of significant interest. At SJMO patients who undergo a thoracoscopic procedures currently receive parenteral opioids or thoracic epidurals for management of pain. The purpose of this study is to determine whether SAPB with bupivacaine and adjuvants can provide superior pain management (decrease pain scores) and decrease opioid consumption, without increasing nausea/vomiting, compared to patients receiving SAPB with bupivacaine alone in patients undergoing video-assisted thoracoscopy. We will be assessing whether the addition of magnesium and buprenorphine to bupivacaine in SAPB will decrease visual analog scale (VAS) pain scores, reduce post-operative total opioid consumption (oral morphine equivalents), and decrease post-operative nausea and vomiting (PONV).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Acute
Keywords
Serratus anterior plane block, video-assisted thoracoscopy, opioid consumption, magnesium, buprenorphine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAPB
Arm Type
Active Comparator
Arm Description
40 Patients - Patients will receive 30 mL of 0.25% bupivacaine injected below the serratus anterior muscle in the caudal direction using ultrasound guidance.
Arm Title
SAPB with Mg
Arm Type
Active Comparator
Arm Description
40 Patients - Patients will receive 30 mL of 0.25% bupivacaine with 150 mg of Mg injected below the serratus anterior muscle in the caudal direction using ultrasound guidance.
Arm Title
SAPB with Mg and Buprenorphine
Arm Type
Active Comparator
Arm Description
40 Patients - Patients will receive 30 mL of 0.25% bupivacaine with 150 mg of Mg and 300 mcg of buprenorphine injected below the serratus anterior muscle in the caudal direction using ultrasound guidance.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution
Intervention Description
Injection of Bupivacaine 0.25% Injectable Solution for SAPB
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg
Intervention Description
Injection of Bupivacaine 0.25% Injectable Solution for SAPB Addition of 150 mg of Magnesium Sulfate as adjuvant
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg, Buprenorphine 300 mcg
Intervention Description
Injection of Bupivacaine 0.25% Injectable Solution for SAPB Addition of 150 mg of Magnesium Sulfate and 300mcg Buprenorphine as adjuvants
Primary Outcome Measure Information:
Title
Post-operative total opioid consumption (oral morphine equivalents)
Description
Total Opioid consumption 24 hours post surgery oral moral morphine equivalents
Time Frame
24 hours after surgery
Title
Visual analog scale (VAS) pain scores
Description
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Time Frame
6 hours after surgery
Title
Visual analog scale (VAS) pain scores
Description
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Time Frame
12 hours after surgery
Title
Visual analog scale (VAS) pain scores
Description
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Incidence of post-operation nausea and vomiting (PONV)
Description
The percentage of the patients who had post-operative nausea and vomiting (PONV) within 24 hours of surgery
Time Frame
24 hours
Title
Acetaminophen consumption
Description
Total acetaminophen consumption in mg
Time Frame
24 hours after surgery
Title
NSAID (ketorolac) consumption
Description
Total NSAID consumption in mg
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients undergoing video-assisted thoracoscopy Exclusion Criteria: Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.) Patients with significant platelet dysfunction Infection at site for regional anesthesia Allergy to local anesthetics Sepsis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandeep Krishnan, M.D.
Phone
(248) 858-6068
Email
sakrishna@med.wayne.edu
Facility Information:
Facility Name
St. Joseph Mercy Oakland Hospital
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Anderson
Phone
248-858-6068

12. IPD Sharing Statement

Plan to Share IPD
No

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Serratus Anterior Plane Block With and Without Adjuvants in Video-assisted Thoracoscopy

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