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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04559347
Other study ID # 2007-48
Secondary ID
Status Suspended
Phase Phase 2
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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