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Post Operative Pain, AcuteNCT05090761

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

A study testing Bupivacaine 0.25% Injectable Solution, Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg and Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg, Buprenorphine 300 mcg in people with Post Operative Pain, Acute, run by Wayne State University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Post Operative Pain, Acute
What is being tested?
Bupivacaine 0.25% Injectable Solution, Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg and Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg, Buprenorphine 300 mcg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
12 Oct 2021to Oct 2022
Phase
Interventional
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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing video-assisted thoracoscopy

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sandeep Krishnan, M.D. contact

(248) 858-6068

sakrishna@med.wayne.edu

United States1 site, 1 recruiting
  • St. Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

    Lena Anderson, 248-858-6068

    Recruiting

Other trials in United States

About this study

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?

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.

Read the 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).

Being tested
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
Keywords
Serratus anterior plane block, video-assisted thoracoscopy, opioid consumption, magnesium, buprenorphine
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Bupivacaine 0.25% Injectable SolutionDrug

    Injection of Bupivacaine 0.25% Injectable Solution for SAPB

  • Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mgDrug

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

  • Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg, Buprenorphine 300 mcgDrug

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

Study groups in NCT05090761
Study groupRoleWhat they receive
SAPBActive comparator40 Patients - Patients will receive 30 mL of 0.25% bupivacaine injected below the serratus anterior muscle in the caudal direction using ultrasound guidance.
Receives: Drug: Bupivacaine 0.25% Injectable Solution
SAPB with MgActive comparator40 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.
Receives: Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg
SAPB with Mg and BuprenorphineActive comparator40 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.
Receives: Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg, Buprenorphine 300 mcg

What is being measured

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

  1. Post-operative total opioid consumption (oral morphine equivalents)

    Total Opioid consumption 24 hours post surgery oral moral morphine equivalents

    Measured: 24 hours after surgery

  2. Visual analog scale (VAS) pain scores

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

    Measured: 6 hours after surgery

  3. Visual analog scale (VAS) pain scores

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

    Measured: 12 hours after surgery

  4. Visual analog scale (VAS) pain scores

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

    Measured: 24 hours after surgery

Secondary outcomes (3)
  1. 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

    Measured: 24 hours

  2. Acetaminophen consumption

    Total acetaminophen consumption in mg

    Measured: 24 hours after surgery

  3. NSAID (ketorolac) consumption

    Total NSAID consumption in mg

    Measured: 24 hours after surgery

Timeline

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

  1. First posted25 Oct 2021
  2. Study start12 Oct 2021
  3. Primary completionOct 2022 (estimated)
  4. Study completionOct 2022 (estimated)

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
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05090761
Sponsor's protocol ID
SAPB in thoracoscopy
Status last verified
Oct 2021
First submitted
12 Oct 2021
Last updated
25 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine 0.25% Injectable Solution, Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg and Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg, Buprenorphine 300 mcg in people with Post Operative Pain, Acute, run by Wayne State University 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Oct 2021. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sandeep Krishnan, M.D. ((248) 858-6068, sakrishna@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative total opioid consumption (oral morphine equivalents) (time frame: 24 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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