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

NCT05090761 | Unknown

• 1 other identifier: SAPB in thoracoscopy
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain, Acute

Keywords

Serratus anterior plane block, video-assisted thoracoscopy, opioid consumption, magnesium, buprenorphine

Outcome Measures

Primary Outcomes (4)

• Post-operative total opioid consumption (oral morphine equivalents)

  Total Opioid consumption 24 hours post surgery oral moral morphine equivalents

  24 hours after surgery

• Visual analog scale (VAS) pain scores

  Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)

  6 hours after surgery

• Visual analog scale (VAS) pain scores

  Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)

  12 hours after surgery

• Visual analog scale (VAS) pain scores

  Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)

  24 hours after surgery

Secondary Outcomes (3)

• Incidence of post-operation nausea and vomiting (PONV)

  24 hours

• Acetaminophen consumption

  24 hours after surgery

• NSAID (ketorolac) consumption

  24 hours after surgery

Study Arms (3)

SAPB

ACTIVE COMPARATOR

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

Drug: Bupivacaine 0.25% Injectable Solution

SAPB with Mg

ACTIVE COMPARATOR

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.

Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg

SAPB with Mg and Buprenorphine

ACTIVE COMPARATOR

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.

Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg, Buprenorphine 300 mcg

Interventions

Bupivacaine 0.25% Injectable Solution DRUG

Injection of Bupivacaine 0.25% Injectable Solution for SAPB

SAPB

Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg DRUG

Injection of Bupivacaine 0.25% Injectable Solution for SAPB Addition of 150 mg of Magnesium Sulfate as adjuvant

SAPB with Mg

Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg, Buprenorphine 300 mcg DRUG

Injection of Bupivacaine 0.25% Injectable Solution for SAPB Addition of 150 mg of Magnesium Sulfate and 300mcg Buprenorphine as adjuvants

SAPB with Mg and Buprenorphine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients undergoing video-assisted thoracoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

St. Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Magnesium Sulfate; Buprenorphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Sandeep Krishnan, M.D.

CONTACT

(248) 858-6068; sakrishna@med.wayne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: October 12, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)