Postoperative Pain Control With Lipossomic Extended Release Bupivacaine

Randomized Trial Comparing Bupivacaine vs Lipossomic Extended Release Bupivacaine for Postoperative Pain Control After Minimally Invasive Thoracic Surgery

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03560362

Enrollment

Registered

2018-06-18

Start date

2015-07-09

Completion date

2018-10-31

Last updated

2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Lung Cancer

Keywords

bupivacaine, lipossomal extended release bupivacaine, Intercostal nerve block, thoracic surgery, minimally invasive surgery

Brief summary

Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.

Detailed description

Patients undergoing minimally invasive thoracic surgery will be randomized to receive 0.05% bupivacaine with 1:200,000 epinephrine (control group) or extended release lipossomal bupivacaine. Primary outcomes are postoperative pain measured by visual analog scale, amount of morphine equivalent narcotics used, and postoperative complications. Patients are excluded if they undergo open thoracotomy, or minimally invasive decortication.

Interventions

DRUGBupivacaine liposome

DRUGBupivacaine / Epinephrine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients who will be undergoing minimally invasive thoracic surgery * Patients who will be undergoing minimally invasive thoracic surgery

Exclusion criteria

* Open surgery * Chronic use of narcotics * Use of pregabalin or similar * Significant liver or kidney dysfunction

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain	3-5 days post op	Pain assessment with Visual Analog Scale (VAS). This is a numeric pain scale widely used in healthcare that ranks pain from 0 (no pain) to 10 (unbearable pain). A pain score below 3 is considered good.

Secondary

Measure	Time frame	Description
Postoperative complications	90 days post op	Any complication occuring in the first 90 days classified according to the Clavien-Dindo classification.
Narcotic used	3-5 days post op	Amount of morphine equivalent dosage used in the postoperative period

Countries

United States

Contacts

Primary ContactBenny Weksler, MD

bweksler@uthsc.edu901-448-2918

Backup ContactSuzie Glass, RN

Suzie.Glass@mlh.org901-448-2918

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026