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Postoperative Pain Control With Lipossomic Extended Release Bupivacaine

University of Tennessee logo

University of Tennessee

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Pain, Postoperative
Lung Cancer

Treatments

Drug: Bupivacaine / Epinephrine
Drug: Bupivacaine liposome

Study type

Interventional

Funder types

Other

Identifiers

NCT03560362
15-03838

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Bupivacaine with epinephrine
Active Comparator group
Description:
Patients will receive intraoperative intercostal nerve block with bupivacaine
Treatment:
Drug: Bupivacaine / Epinephrine
Lipossomal extended release bupivacaine
Experimental group
Description:
Patients will receive intraoperative intercostal nerve block with lipossomal extended release bupivacaine
Treatment:
Drug: Bupivacaine liposome

Trial contacts and locations

1

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Central trial contact

Benny Weksler, MD; Suzie Glass, RN

Data sourced from clinicaltrials.gov

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