NCT00295945

Brief Summary

RATIONALE: Giving pain medication into the space between the wall of the spinal canal and the covering of the spinal cord or giving it into a vein may help lessen pain caused by cancer surgery. It is not yet known whether epidural analgesia is more effective than patient-controlled analgesia in controlling pain in patients who have undergone surgery for gynecologic cancer. PURPOSE: This randomized clinical trial is studying epidural analgesia to see how well it works compared to patient-controlled analgesia in treating patients who have undergone surgery for gynecologic cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

3.1 years

First QC Date

February 23, 2006

Last Update Submit

May 19, 2014

Conditions

Cervical CancerEndometrial CancerFallopian Tube CancerOvarian CancerPainPerioperative/Postoperative ComplicationsSarcoma

Keywords

painperioperative/postoperative complicationsstage III cervical cancerrecurrent cervical cancerstage IB cervical cancerstage IIB cervical cancerstage IVB cervical cancerstage IA cervical cancerstage IIA cervical cancerstage IVA cervical cancerstage I endometrial carcinomastage II endometrial carcinomastage III endometrial carcinomastage IV endometrial carcinomarecurrent endometrial carcinomastage I uterine sarcomastage II uterine sarcomastage III uterine sarcomastage IV uterine sarcomarecurrent uterine sarcomaovarian sarcomarecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorstage IV ovarian epithelial cancerstage IV ovarian germ cell tumorovarian stromal cancerrecurrent fallopian tube cancerstage IA fallopian tube cancerstage IB fallopian tube cancerstage IC fallopian tube cancerstage IIA fallopian tube cancerstage IIB fallopian tube cancerstage IIC fallopian tube cancerstage IIIA fallopian tube cancerstage IIIB fallopian tube cancerstage IIIC fallopian tube cancerstage IV fallopian tube cancerstage IA ovarian epithelial cancerstage IB ovarian epithelial cancerstage IC ovarian epithelial cancerstage IIA ovarian epithelial cancerstage IIB ovarian epithelial cancerstage IIC ovarian epithelial cancerstage IIIA ovarian epithelial cancerstage IIIB ovarian epithelial cancerstage IIIC ovarian epithelial cancerstage IA ovarian germ cell tumorstage IB ovarian germ cell tumorstage IC ovarian germ cell tumorstage IIA ovarian germ cell tumorstage IIB ovarian germ cell tumorstage IIC ovarian germ cell tumorstage IIIA ovarian germ cell tumorstage IIIB ovarian germ cell tumorstage IIIC ovarian germ cell tumor

Outcome Measures

Primary Outcomes (1)

  • Time to return to bowel function at discharge

    Days

Secondary Outcomes (1)

  • Pain score daily

    Days

Study Arms (2)

PCA

Patient-controlled intravenous analgesia

Drug: hydromorphone hydrochloride

PCEA

Perioperative patient-controlled epidural analgesia

Drug: fentanyl citrateDrug: ropivacaine hydrochloride

Interventions

fentanyl citrateDRUG
PCEA
hydromorphone hydrochlorideDRUG
PCA
ropivacaine hydrochlorideDRUG
PCEA

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

DISEASE CHARACTERISTICS: * Diagnosis of a gynecologic malignancy * Scheduled to undergo open abdominal/pelvic surgery (i.e., laparotomy) on the gynecologic oncology service at the University of California San Francisco Medical Center * No failed epidural catheters (for patients choosing epidural analgesia) * No lumbar epidurals (for patients choosing epidural analgesia)

DISEASE CHARACTERISTICS: * Diagnosis of a gynecologic malignancy * Scheduled to undergo open abdominal/pelvic surgery (i.e., laparotomy) on the gynecologic oncology service at the University of California San Francisco Medical Center * No failed epidural catheters (for patients choosing epidural analgesia) * No lumbar epidurals (for patients choosing epidural analgesia) PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsFallopian Tube NeoplasmsOvarian NeoplasmsPainPostoperative ComplicationsSarcomaCarcinoma, Ovarian Epithelial

Interventions

FentanylHydromorphoneRopivacaine

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Lee-may Chen, MD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2006

First Posted

February 24, 2006

Study Start

March 1, 2005

Primary Completion

April 1, 2008

Study Completion

December 1, 2009

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

US(1)