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

Thoracic Surgery Clinical Trial

Official title:

Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivicaine) Versus Continuous Erector Spinae Plane Block Catheter in Patients Undergoing Video Assisted Thoracoscopic (VAT) Surgery; Single Center, Non Inferiority, Open Label, Randomized Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04559347
• Other study ID #: 2007-48
• Status: Suspended
• Phase: Phase 2
• Start date: December 10, 2020
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: The Guthrie Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this research is to compare Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (a long acting local anesthetic) to Ropivacaine (0.5% bolus followed by 0.2% infusion of local anesthetic using a catheter) in patients undergoing video assisted thoracoscopic (VAT) surgery.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 74
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

Drug:
• Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
Single shot for erector spinae block
• Ropivacaine (0.5% bolus followed by 0.2% infusion)
Continuous catheter infusion for erector spinae plane block

Locations

Country	Name	City	State
United States	Robert Packer Hospital	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Poovendran Saththasivam

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rated Pain Scale (NRP)	Patient reported pain scale (0-10)	3 days post-operative
Secondary	Post-operative opioid consumption	Post-operative opioid consumption in morphine equivalents to determine total morphine.	3 days post-operative
Secondary	Total Intraoperative narcotic	Total opioids administered in the operating room surgery in morphine equivalents.	At end of surgery
Secondary	Total adjunct pain medication consumption	Non-narcotic pain medications such as acetaminophen, gabapentin, ketorolac, etc.	3 days post-operative
Secondary	Incentive spirometry changes from preoperative baseline to 3 days post-operative	Incentive spirometry change from preoperative baseline to 3 days post-operative	3 days post-operative
Secondary	Length of hospital stay	Number of days from admission to discharge	From date of admission until date of discharge, an average of 3 days
Secondary	Postoperative Quality of Recovery score (QOR-15)	A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.	3 days post-operative
Secondary	Adverse events frequency	Frequency and type of adverse events associated with Single Shot Liposomal Bupivacaine (Exparel)/Bupivacaine (SS) and Ropivacaine 0.5% BOLUS followed by Ropivacaine 0.2% continuous infusion	up to 72 hours