Efficacy Between Serratus Plane Block And Local Infiltration In Vats

NCT03642457 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: GCO 17-1294
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon. Serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores. The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance. The purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.

Conditions

Lung Cancer

Keywords

Video assisted thoracoscopic surgery; Serratus plane block; local infiltration

Outcome Measures

Primary Outcomes (1)

• Amount of Opioid Consumption

  The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.

  up to 24 hours post procedure

Secondary Outcomes (5)

• Time to First Dose of Narcotic Administration

  up to 24 hours post procedure

• PACU Length of Stay

  average 3-4 hours post procedure

• ICU Length of Stay

  up to 40 hours post procedure

• Visual Analogue Score (VAS)

  up to 24 hours post procedure

• Patient Satisfaction Score

  up to 24 hours post procedure

Study Arms (2)

Serratus Plane Group

ACTIVE COMPARATOR

Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.

Drug: Bupivacaine; Drug: Bupivacaine liposome

Placebo Group

PLACEBO COMPARATOR

Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.

Drug: Bupivacaine liposome

Interventions

Bupivacaine DRUG

20 cc 0.5%

Serratus Plane Group

Bupivacaine liposome DRUG

133mg liposomal bupivacaine

Placebo Group; Serratus Plane Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (American Society of Anesthesiology) class I-IV
• age 81-75

You may not qualify if:

• ASA class V
• morbid obesity
• patient refusal
• patients with chronic pain or on pain medications
• allergy to LA
• patients receiving any additional regional techniques
• coagulopathy
• patients receiving systemic anticoagulation
• local infection
• procedures anticipated to last more than 5 hours.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Mount Sinai St. Luke's Hospital

New York, New York, 10019, United States

Location

Mount Sinai West Hospital

New York, New York, 10019, United States

Location

Related Publications (3)

• Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.

  PMID: 27543533 BACKGROUND

• Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.

  PMID: 21831090 BACKGROUND

• Thoracic paravertebral block versus pectoral nerve block for analgesia after breast surgery. Egypt J Anaesth. 2013; 30: 129-135. Wahba, SS and Kamal, SM.

  BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Poonam Pai
• Organization: Icahn School of Medicine at Mount Sinai

poonam.paibantwalhebbalasankatte@mountsinai.org

347-569-4816

Study Officials

• Yan Lai, MD, MPH

  cahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient, surgeon, and anesthesiologist in the case will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: September 30, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)