Postoperative Pain Management After Minimally Invasive Esophagectomy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02042313

Acronym

MIEPVBEA

Enrollment

Registered

2014-01-22

Start date

2014-02-28

Completion date

Unknown

Last updated

2015-12-16

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

Conditions

Esophageal Cancer

Brief summary

Esophagectomy is a major surgical procedure often associated with significant morbidity and mortality and significant level of postoperative pain. In contrast to open esophagectomy where epidural pain control has been considered as a gold standard and could be crucial in affecting outcome the analgesic scheme for minimally invasive esophagectomy (MIE) is yet to be established. We would like to compare continuous epidural analgesia and continuous paravertebral block combined with single shot subcostal transversus abdominis plane (TAP) block in the analgesic effects, levels of cytokines, and postoperative complications in patients receiving MIE.

Interventions

OTHERcontinuous epidural infusion

OTHERcombined paravertebral infusion and single shot of TAP block

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patient has a physical status between ASA I and III * 20 - 75 years of age * Patient has signed an informed consent * Without contraindication of GA, EA or PVB

Exclusion criteria

* ASA \> III * Inability to provide informed consent * Bleeding disorders * Being pregnant * Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), * Allergy to amide-type local anesthetics or NSAIDs * Infection at the thoracic paravertebral injection site * Severe spine or chest wall deformity * Patients with major psychosis or drug and alcohol abuse * Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease * Patients with physical disability that precludes complete cooperation

Design outcomes

Primary

Measure	Time frame
Intraoperative hypotension ( > 30% decline in the preoperative systolic/diastolic blood pressure)	during operation

Secondary

Measure	Time frame
NRS pain score	postoperative day 0 to 4

Other

Measure	Time frame
Tidal volume	postoperative day 1 to4

Countries

Taiwan

Contacts

Primary ContactNai Liang Li, MD

lnl@kfsyscc.org886-2-28970011

Outcome results

None listed

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