Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain

A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00373633

Enrollment

Registered

2006-09-08

Start date

2006-09-30

Completion date

2012-01-31

Last updated

2014-08-15

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

Conditions

THoracotomy

Keywords

THoracic Surgery, thoracic epidural, epidural, thoracotomy, intercostal nerve block, intercostal, nerve block

Brief summary

We will compare thoracic epidural anesthesia which is presently used for management of pain after thoracotomy to an intra-operatively placed extrapleural intercostal catheter. The study wil be double blinded and prospective.

Detailed description

The aim of this study is to evaluate the efficacy of thoracic epidural vs. continuous extra-pleural intercostal local anesthesia for the treatment of post thoracotomy pain in adult patients. Study patients will be randomized between the thoracic epidural and continuous extrapleural catheter groups\[Figure 1\]. Because thoracic epidural anesthesia is the gold standard but continuous extrapleural intercostal local anesthesia is potentially easier and less prone to complications, the study will be structured as an equivalence study. The null hypothesis (Ho) is that continuous intercostal nerve blockade is worse than epidural for post-thoracotomy pain management. Therefore, the alternative hypothesis (Ha) is then that continuous intercostal nerve blockade is equal to or better than epidural for post-thoracotomy pain management.

Interventions

PROCEDUREThoracic Epidural

Gold standard for post thoracotomy pain

PROCEDUREExtrapleural Intercostal Catheter

Continuous extra-pleural intercostal local anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Unilateral thoracotomy * Video Assisted thoracotomy with high likely hood of converting to open thoracotmoy

Exclusion criteria

* Bilateral thoracotomy * Planned bilateral thoracotomy * Planned chest wall resection * Planned combined thoracotomy and laparotomy procedure * VATS procedure without conversion to unilateral thoracotomy * Emergency operation * Critically ill patients * Patients who require an assistive device (i.e. cane, walker, or wheel chair) for mobility * Patients who are unable to give informed consent * Patients with preoperative chronic back or chest wall pain * Empyema or other infective condition increasing the risk of epidural infection * Coagulopathy * Decision of the surgeon or anesthesiologist, or choice of the patient * Infection at site of epidural placement * Patients with other co morbidities which exclude thoracic epidural placement * Patients under the age of 18 years

Design outcomes

Primary

Measure	Time frame
pain control-visual analog pain score	post surgery monitoring

Secondary

Measure	Time frame
respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities	post surgery monitoring

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026