Local Anesthetic as Single Shot Versus Catheter in Patients Undergoing Video Assisted Thoracoscopic Surgery

NCT04559347 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2007-48
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to compare a single shot long acting local anesthetic to catheter infusion of local anesthetic in patients undergoing video assisted thoracoscopic (VAT) surgery.

Conditions

Thoracic Surgery

Keywords

Thoracic surgery

Outcome Measures

Primary Outcomes (12)

• Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative

  Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  0-4 hours post operative

• Numeric Rated Pain Scale at Rest 4-8 Hours Post-operative

  Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  4-8 hours post operative

• Numeric Rated Pain Scale at Rest 8-12 Hours Post-operative

  Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  8-12 hours post operative

• Numeric Rated Pain Scale at Rest 12-24 Hours Post-operative

  Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  12-24 hours post operative

• Numeric Rated Pain Scale at Rest 24-48 Hours Post-operative

  Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  2 days post operative

• Numeric Rated Pain Scale 48-72 Hours Post-operative

  Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  3 days post-operative

• Numeric Rated Pain Scale With Cough 0-4 Hours Post-operative

  Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  0-4 hours post-operative

• Numeric Rated Pain Scale With Cough 4-8 Hours Post-operative

  Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  4-8 hours post-operative

• Numeric Rated Pain Scale With Cough 8-12 Hours Post-operative

  Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  8-12 hours post-operative

• Numeric Rated Pain Scale With Cough 12-24 Hours Post-operative

  Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  12-24 hours post-operative

• Numeric Rated Pain Scale With Cough 24-48 Hours Post-operative

  Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  24-48 hours post-operative

• Numeric Rated Pain Scale With Cough 48-72 Hours Post-operative

  Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable

  48-72 hours post-operative

Secondary Outcomes (35)

• Opioid Consumption in Morphine Equivalent Dose 0-4 Hours Post-operative

  0-4 hours post-operative

• Opioid Consumption in Morphine Equivalent Dose 4-8 Hours Post-operative

  4-8 hours post-operative

• Opioid Consumption in Morphine Equivalent Dose 8-16 Hours Post-operative

  8-16 hours post-operative

• Opioid Consumption in Morphine Equivalent Dose 16-24 Hours Post-operative

  16-24 hours post-operative

• Opioid Consumption in Morphine Equivalent Dose 24-48 Hours Post-operative

  24-48 hours post-operative

Study Arms (2)

Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

EXPERIMENTAL

Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic

Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

Continuous catheter infusion ropivacaine

ACTIVE COMPARATOR

Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic

Drug: Ropivacaine (0.5% bolus followed by 0.2% infusion)

Interventions

Liposomal Bupivacaine (EXPAREL®)/Bupivacaine DRUG

Single shot for erector spinae block

Also known as: EXPAREL®/Bupivacaine

Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

Ropivacaine (0.5% bolus followed by 0.2% infusion) DRUG

Continuous catheter infusion for erector spinae plane block

Also known as: Ropivacaine

Continuous catheter infusion ropivacaine

Eligibility Criteria

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

You may qualify if:

• Subjects who are age \> 18, undergoing video thoracoscopic surgery and following Guthrie Robert Packer Hospital's Enhanced Recovery After Surgery (ERAS) protocol for Thoracic Surgery.

You may not qualify if:

• weight \< 50 kg, pregnant subjects,
• left ventricular ejection fraction \< 30%,
• history of drug or narcotic abuse,
• history of allergic to amide local anesthetic,
• presence of contraindication for erector spinae plane block (local skin infection, sepsis, severe coagulopathy)
• unable to provide consent,
• unable to use pain rating scales as demonstrated by verbal feedback
• preoperative chronic pain on narcotics,
• history of renal insufficiency ( Creatinine \> 1.5 mg/dl),
• preoperative mild liver impairment ( i.e. AST/ALT above 1.5 times the upper normal limit)

Sponsors & Collaborators

• Poovendran Saththasivam: lead

Study Sites (1)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Poovendran Saththasivam MD
• Organization: The Guthrie Clinic

Poovendran.Saththasivam@guthrie.org

5708874882

Study Officials

• Poovendran Saththasivam, MD

  The Guthrie Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Compare Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (a long acting local anesthetic) to Ropivacaine (0.5% followed by 0.2% infusion using a catheter) in patients undergoing video assisted thoracoscopic (VAT) surgery.

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 22, 2020
• Study Start: December 10, 2020
• Primary Completion: January 10, 2024
• Study Completion: August 7, 2024
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)