Study of Exparel Versus Epidural for Pain Control After Thoracotomy

Randomized Non-inferiority Trial of Continuous Thoracic Epidural Analgesia Versus Single Intercostal Nerve Block After Thoracotomy

Unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects.

Study Overview

• Status: Completed
• Conditions: Pain Following Thoracotomy Surgery
• Intervention / Treatment: Drug: Epidural; Drug: Intercostal Bupivicaine (Exparel)

Detailed Description

In this study we will study to see if a single set of unilateral intercostal nerve blocks provides pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects. Although the anesthesiologists involved in providing care for patients having thoracotomy incisions at St. Mary's Hospital are experts at placing thoracic epidural catheters, this study will attempt to show that a less technically challenging procedure done by surgeons intra-operatively can provide comparable pain relief.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years and older
• Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy).

Exclusion Criteria:

• Planned chest wall resection or abdominal incision and/or gastroesophageal surgery;
• Current enrollment in another post-thoracotomy analgesic research protocol; pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or postherpetic neuralgia in a thoracic distribution);
• Daily opioid therapy;
• Current gabapentin or pregabalin therapy;
• Allergy to any study medication; coagulation or infectious issues that would preclude epidural catheter placement;
• Severe psychological disorders or inability to understand the study protocol; -Prisoners or other institutionalized individuals;
• Severe hepatic, renal or cardiovascular disorders.
• Women who are pregnant will not be included in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural; In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.	Drug: Epidural
Active Comparator: Intercostal bupivicaine (Exparel); In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.	Drug: Intercostal Bupivicaine (Exparel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores With Cough on First Postoperative Day	Pain with cough documented using the numerical rating scale pain scores (0-10)	In the morning (8 am) on first postoperative day
Pain Scores With Cough on the Second Postoperative Day	Pain with cough documented using the numerical rating scale pain scores (0-10). Zero indicates no pain, and 10 indicates the worst pain one could imagine.	In the morning (8 am) on the second postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores at Rest in the Morning on the First Postoperative Day	NRS pain scores on a 0-10 scale at rest at 8 am on the first postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine.	Each morning for two days postoperative
Pain Scores at Rest on the Second Postoperative Day	NRS pain scores on a 0-10 scale at rest in the morning on the second postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine.	Each morning for two days postoperative

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: James D Hannon, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2014
• Primary Completion (Actual): October 9, 2018
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: June 30, 2014
• First Posted (Estimate): July 1, 2014

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Thoracotomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 14-002940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO