Cervical CancerNCT00295945
Epidural Analgesia or Patient-Controlled Analgesia in Treating Patients Who Have Undergone Surgery for Gynecologic Cancer
An observational study of Cervical Cancer and Endometrial Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer
- What is being tested?
- fentanyl citrate, hydromorphone hydrochloride and ropivacaine hydrochloride
- Type of treatment
- Injection or infusion
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: Outcomes of Perioperative Epidural Analgesia in Gynecologic Oncology Patients: A Parallel Prospective Cohort and Randomized Clinical Study
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.
Read the detailed description
OBJECTIVES:
- Determine whether the gradual weaning of an epidural opioid can shorten the duration of postoperative ileus, without worsening pain control, in patients who have undergone surgery for gynecologic cancer.
- Compare postoperative pain management in patients treated with perioperative epidural analgesia vs patient controlled analgesia.
- Compare time to ambulation, return of bowel function, and readiness for hospital discharge in patients treated with these pain management interventions.
- Compare the incidence of perioperative complications (e.g., bleeding, hypotension, thromboembolic events, pneumonia, wound infection, myocardial infection, or death) in patients treated with these pain management interventions.
OUTLINE: This is a partially randomized, double-blind, parallel-group study. Patients choose between epidural analgesia or patient controlled analgesia (PCA) for perioperative pain management. Patients for whom an epidural is contraindicated receive a PCA. Patients are assigned to 1 of 2 treatment groups. Patients in group 1 are stratified according to bowel resection surgery (yes vs no) and prior abdominal surgery (yes vs no).
- Group 1 (epidural): Patients undergo placement of a thoracic epidural catheter followed by abdominal/pelvic surgery. Patients then begin an epidural infusion of ropivacaine hydrochloride and fentanyl immediately after surgery (postoperative day 0). Patients may also be supplemented with a patient controlled demand dose. The day after surgery (postoperative day 1), patients are randomized (as long as there is adequate pain control) to 1 of 2 epidural management arms.
- Arm I: Patients continue to receive the epidural infusion until they can be weaned to oral pain medication.
- Arm II: Patients undergo daily weaning of the fentanyl concentration of the epidural infusion.
- Group 2 (PCA): Patients begin PCA immediately after undergoing abdominal/pelvic surgery (postoperative day 0). Patients receive a demand schedule of hydromorphone IV until they can be weaned to oral pain medication.
In both groups, the Gynecologic Oncology pain service may make adjustments to the epidural infusion or PCA for optimal pain management until the patient can be weaned to oral pain medication.
PROJECTED ACCRUAL: A total of 224 patients will be accrued for this study.
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Pain, Perioperative/Postoperative Complications
- Being tested
- fentanyl citrate, hydromorphone hydrochloride, ropivacaine hydrochloride
- Keywords
- pain, perioperative/postoperative complications, stage III cervical cancer, recurrent cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage IVB cervical cancer, stage IA cervical cancer, stage IIA cervical cancer, stage IVA cervical cancer, stage I endometrial carcinoma, stage II endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma, stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Pain, Postoperative Complications, Sarcoma, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl citrateDrug
hydromorphone hydrochlorideDrug
ropivacaine hydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| PCA | Patient-controlled intravenous analgesia Receives: Drug: hydromorphone hydrochloride | |
| PCEA | Perioperative patient-controlled epidural analgesia Receives: Drug: fentanyl citrate; Drug: ropivacaine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to return to bowel function at discharge
Measured: Days
Secondary outcomes (1)
Pain score daily
Measured: Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startMar 2005
- Primary completionApr 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee-may Chen, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295945
- Sponsor's protocol ID
- CDR0000459963
- Other IDs
- UCSF-03423, UCSF-H10588-24197-02
- Status last verified
- May 2014
- First submitted
- 23 Feb 2006
- Last updated
- 20 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Perioperative Epidural Analgesia in Gynecologic Oncology Patients: A Parallel Prospective Cohort and Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT00295945
- Acronym / sponsor ID
- CDR0000459963
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Pain, Perioperative/Postoperative Complications
- Keywords
- pain, perioperative/postoperative complications, stage III cervical cancer, recurrent cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage IVB cervical cancer, stage IA cervical cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Determine whether the gradual weaning of an epidural opioid can shorten the duration of postoperative ileus, without worsening pain control, in patients who have undergone surgery for gynecologic cancer.
- Compare postoperative pain management in patients treated with perioperative epidural analgesia vs patient controlled analgesia.
- Compare time to ambulation, return of bowel function, and readiness for hospital discharge in patients treated with these pain management interventions.
- Compare the incidence of perioperative complications (e.g., bleeding, hypotension, thromboembolic events, pneumonia, wound infection, myocardial infection, or death) in patients treated with these pain management interventions.
OUTLINE: This is a partially randomized, double-blind, parallel-group study. Patients choose between epidural analgesia or patient controlled analgesia (PCA) for perioperative pain management. Patients for whom an epidural is contraindicated receive a PCA. Patients are assigned to 1 of 2 treatment groups. Patients in group 1 are stratified according to bowel resection surgery (yes vs no) and prior abdominal surgery (yes vs no).
- Group 1 (epidural): Patients undergo placement of a thoracic epidural catheter followed by abdominal/pelvic surgery. Patients then begin an epidural infusion of ropivacaine hydrochloride and fentanyl immediately after surgery (postoperative day 0). Patients may also be supplemented with a patient controlled demand dose. The day after surgery (postoperative day 1), patients are randomized (as long as there is adequate pain control) to 1 of 2 epidural management arms.
- Arm I: Patients continue to receive the epidural infusion until they can be weaned to oral pain medication.
- Arm II: Patients undergo daily weaning of the fentanyl concentration of the epidural infusion.
- Group 2 (PCA): Patients begin PCA immediately after undergoing abdominal/pelvic surgery (postoperative day 0). Patients receive a demand schedule of hydromorphone IV until they can be weaned to oral pain medication.
In both groups, the Gynecologic Oncology pain service may make adjustments to the epidural infusion or PCA for optimal pain management until the patient can be weaned to oral pain medication.
PROJECTED ACCRUAL: A total of 224 patients will be accrued for this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCA | – | Drug: hydromorphone hydrochloridePatient-controlled intravenous analgesia |
| PCEA | – | Drug: fentanyl citrate, Drug: ropivacaine hydrochloridePerioperative patient-controlled epidural analgesia |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fentanyl citrate | Drug | PCEA |
| hydromorphone hydrochloride | Drug | PCA |
| ropivacaine hydrochloride | Drug | PCEA |
Primary outcome
Time to return to bowel function at discharge
Time frame: Days
1 secondary outcome
Pain score daily
Time frame: Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee-may Chen, MD study chair
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Endometrial Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to return to bowel function at discharge (time frame: Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.