Study of Exparel Versus Epidural for Pain Control After Thoracotomy

NCT02178553 | Completed Phase 4 Results

• 1 other identifier: 14-002940
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain Following Thoracotomy Surgery

Keywords

Thoracotomy; Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pain Scores at Rest in the Morning on the First Postoperative Day

  Each morning for two days postoperative

• Pain Scores at Rest on the Second Postoperative Day

  Each morning for two days postoperative

Study Arms (2)

Epidural

ACTIVE COMPARATOR

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

Intercostal bupivicaine (Exparel)

ACTIVE COMPARATOR

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)

Interventions

Epidural DRUG

Epidural

Intercostal Bupivicaine (Exparel) DRUG

Intercostal bupivicaine (Exparel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

The study was stopped before the target number of participants was achieved.

Results Point of Contact

• Title: Dr. James D. Hannon
• Organization: Mayo Clinic Rochester

hannon.james@mayo.edu

507-284-7289

Study Officials

• James D Hannon, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 1, 2014
• Study Start: October 15, 2014
• Primary Completion: October 9, 2018
• Study Completion: January 25, 2019
• Last Updated: January 9, 2020
• Results First Posted: January 9, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)