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Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas

NCT01438476 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2020-02-12

Study results available
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Summary

The goal of this clinical research study is to learn if there is a difference in patients' quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after surgery on the liver and/or pancreas. Researchers want to learn which method helps people to recover more completely and more quickly after surgery.

The 2 kinds of pain control are intravenous (IV) pain management and epidural pain management.

Conditions

Interventions

PROCEDURE

Intravenous Patient-Controlled Analgesia (IVPCA)

Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.

PROCEDURE

Thoracic Epidural Analgesia (TEA)

Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.

BEHAVIORAL

Questionnaires

Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

BEHAVIORAL

Pain Assessment

Hourly post surgery rating level of pain on a scale of 0-10.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jean-Nicolas Vauthey, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-26
Primary Completion
2017-10-18
Completion
2017-10-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01438476 on ClinicalTrials.gov