CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 178 enrolled
Drug / intervention
Intravenous Patient-Controlled Analgesia (IVPCA) +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01438476
NCT01438476Phase 3Completed
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Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient Controlled Analgesia (3:1) in Patients Undergoing Liver and/or Pancreatic Resection

M.D. Anderson Cancer Center·interventional·Posted Sep 22, 2011·Updated Feb 12, 2020

In Brief

A Phase 3 clinical trial evaluating Intravenous Patient-Controlled Analgesia (IVPCA), Thoracic Epidural Analgesia (TEA), and 2 other interventions for Liver Cancer and Pancreatic Cancer. Completed, enrolled 178 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cancer, Pancreatic Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2011
Enrollment StartJan 26, 2012
Primary CompletionOct 18, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.8 years ago

Interventions

Intravenous Patient-Controlled Analgesia (IVPCA)procedure

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

Thoracic Epidural Analgesia (TEA)procedure

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.

Questionnairesbehavioral

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

Pain Assessmentbehavioral

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