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OpenTrials
Completed

NCT Number: NCT02178553

Study of Exparel Versus Epidural for Pain Control After Thoracotomy

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Rochester, Minnesota, 55902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epidural

Drug

Intercostal Bupivicaine (Exparel)

Drug

Primary outcomes

  1. Pain Scores With Cough on First Postoperative Day

    Time frame: In the morning (8 am) on first postoperative day

    Pain with cough documented using the numerical rating scale pain scores (0-10)

  2. Pain Scores With Cough on the Second Postoperative Day

    Time frame: In the morning (8 am) 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.

Secondary outcomes

  1. Pain Scores at Rest in the Morning on the First Postoperative Day

    Time frame: Each morning for two days postoperative

    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.

  2. Pain Scores at Rest on the Second Postoperative Day

    Time frame: Each morning for two days postoperative

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jul 1, 2014
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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