Postoperative PainPhase 3NCT00136682
Patient-Controlled Epidural Analgesia (PCEA) for Patients Who Have Had Major Open Gynecologic Surgery
A Phase 3 study of Postoperative Pain, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Recovery after major abdominal surgery can be longer than other types of surgery. This is because often after abdominal surgery, the bowel does not work normally. When this happens, patients are unable to pass gas. This can lead to bloating, pain, nausea and vomiting. These symptoms are called postoperative ileus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jul 2007
- Phase
- Phase 3
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing a laparotomy for major abdominal or pelvic surgery by the gynecology service
- Patients 18 years or older
- Patients who have signed an approved informed consent form
Who cannot join
- Patients undergoing total pelvic exenteration
- Patients undergoing laparoscopy only
- Patients undergoing palliative surgery for bowel obstruction
- Patients undergoing emergent operations
- Inability to take oral intake
- Current history of chronic (three months) opioid use or known active alcohol abuse
Show all 15Show fewer
- Patients with significant cognitive impairment or documented psychologic impairment
- Patients with a history of documented anaphylaxis or contraindication to any of the study medications or standardized intraoperative medications will be excluded from study. These include:
- Morphine
- Bupivicaine
- Contraindication to epidural catheter placement. This includes:
- Documented preoperative coagulopathy: international normalized ratio (INR) < 1.3 and partial thromboplastin time (PTT) < 42
- Evidence of infection at potential epidural site
- Prior extensive spinal surgery or major spinal deformity
- Platelets > 100K (bleeding diatheses, preoperative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant post-operatively)
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Postoperative Recovery in Patients Receiving Patient-Controlled Epidural Analgesia (PCEA) Compared to Patient-Controlled Intravenous Analgesia (PCA) After Major Open Gynecologic Surgery: A Randomized Controlled Trial
Recovery after major abdominal surgery can be longer than other types of surgery. This is because often after abdominal surgery, the bowel does not work normally. When this happens, patients are unable to pass gas. This can lead to bloating, pain, nausea and vomiting. These symptoms are called postoperative ileus.
We, the researchers at Memorial Sloan-Kettering Cancer Center (MSKCC), are doing this study to compare two methods of treating pain during and after major gynecological surgery. The two methods are called patient-controlled epidural analgesia (PCEA) and patient-controlled intravenous analgesia (PCA). PCA is the standard of care for women having major gynecological surgery. We are going to compare PCEA to PCA to see if PCEA will improve recovery after major gynecologic surgery.
PCEA is a well established method used to ease pain in many settings such as during childbirth and bowel surgery. There have been several studies showing that PCEA is as good as and sometimes better for pain relief than PCA. PCEA may help the bowel work better by preventing ileus after surgery. However, this has never been looked at in women having major gynecologic surgery. This study will also look at whether preventing this ileus will lead to patients going home or returning to regular activities sooner.
Read the detailed description
The objective of this study is pain at rest and coughing in addition to determine the effect of intraoperative and postoperative thoracic patient-controlled epidural analgesia (PCEA) compared to postoperative intravenous patient-controlled analgesia (PCA) on postoperative recovery parameters, such as time to potential discharge and resumption of intestinal function after major open gynecologic surgery. The population included in this study will be women undergoing a laparotomy for major abdominal or pelvic surgery by the gynecology service. There will be a total of 240 women recruited for this study, with an accrual rate of 5 to 10 patients per month. This study will be a randomized controlled clinical trial. Subjects will be randomized to either general anesthesia with postoperative intravenous patient controlled analgesia (control group) or general anesthesia with intraoperative thoracic epidural anesthesia and postoperative thoracic patient-controlled epidural analgesia (treatment group). This study will not be blinded because of the ethical issues with placing a "sham" epidural catheter in half of the study participants. These patients will be followed prospectively and relevant postoperative parameters will be measured in both groups and compared. This study will address the potential benefits of epidural analgesia on multiple measurements of postoperative recovery. This study will address the potential benefits of epidural analgesia on multiple measurements of postoperative recovery. The primary outcome of interest in this study is pain at rest and when coughing. The secondary outcome is the time to potential discharge.
- Conditions
- Postoperative Pain
- Being tested
- patient-controlled epidural analgesia (PCEA), patient-controlled intravenous analgesia (PCA)
- Keywords
- Major abdominal or pelvic surgery, Patient-Controlled Epidural Analgesia (PCEA), Length of hospital stay after surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-controlled epidural analgesia (PCEA)Drug
During the consent process you will be given a patient data sheet to assess your baseline pain and itchiness. While in the hospital you will be given a patient data sheet to fill out information regarding pain, nausea, when you passed gas, and when you ate food. This will be done once a day by a research assistant or by the research investigators.
patient-controlled intravenous analgesia (PCA)Drug
During the consent process you will be given a patient data sheet to assess your baseline pain and itchiness. While in the hospital you will be given a patient data sheet to fill out information regarding pain, nausea, when you passed gas, and when you ate food. This will be done once a day by a research assistant or by the research investigators.
| Study group | Role | What they receive |
|---|---|---|
| (PCEA) | Active comparator | patient-controlled epidural analgesia PCEA involves having an epidural catheter placed before surgery.The epidural catheter will be used during surgery to give drugs, such as morphine and a local anesthetic bupivacaine, which will help control pain. After surgery, a constant flow of pain-reducing medicine, such as morphine, will be given through the catheter. This is controlled by the patient. Receives: Drug: patient-controlled epidural analgesia (PCEA) |
| PCA | Active comparator | patient-controlled intravenous analgesia (PCA) PCA involves placing a tube into the patient's vein after surgery. The tube is connected to a pump that is controlled by the patient. The pump holds a medicine, such as morphine, that eases pain. Receives: Drug: patient-controlled intravenous analgesia (PCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at rest and when coughing - assessed by visual analog scale (VAS)
Measured: conclusion of the study
Secondary outcomes (12)
The time (in days) to potential discharge based on documentation of all of the discharge criteria below: Toleration of diet (as assessed by tolerating clear fluid diet for 24 hours without nausea requiring antiemetic or vomiting within 4 hours of a meal)
Measured: conclusion of the study
Passing of flatus (as assessed by patient)
Measured: conclusion of the study
Absence of fever for 24 hours
Measured: conclusion of the study
Actual length of stay in hospital (in days). This may be different from actual time of potential discharge as met by criteria in primary outcome
Measured: conclusion of the study
Nausea (yes/no)
Measured: conclusion of the study
Vomiting (number episodes per day)
Measured: conclusion of the study
Use of anti-emetics per day (yes/no)
Measured: conclusion of the study
Pruritus per day (yes/no)
Measured: conclusion of the study
Overall patient satisfaction - questionnaire
Measured: conclusion of the study
Postoperative complications - complications occurring within 30 days of surgery as assessed by MSKCC surgical secondary events grading system
Measured: conclusion of the study
Complications related to intraoperative events (anesthetic and surgical)
Measured: conclusion of the study
Complications arising from analgesic techniques
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startAug 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Nadeem R. Abu-Rustum, M.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136682
- Sponsor's protocol ID
- 04-091
- Status last verified
- Nov 2008
- First submitted
- 25 Aug 2005
- Last updated
- 10 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Recovery in Patients Receiving Patient-Controlled Epidural Analgesia (PCEA) Compared to Patient-Controlled Intravenous Analgesia (PCA) After Major Open Gynecologic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00136682
- Acronym / sponsor ID
- 04-091
- Conditions
- Postoperative Pain
- Keywords
- Major abdominal or pelvic surgery, Patient-Controlled Epidural Analgesia (PCEA), Length of hospital stay after surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 29 Aug 2005 (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.
Recovery after major abdominal surgery can be longer than other types of surgery. This is because often after abdominal surgery, the bowel does not work normally. When this happens, patients are unable to pass gas. This can lead to bloating, pain, nausea and vomiting. These symptoms are called postoperative ileus.
We, the researchers at Memorial Sloan-Kettering Cancer Center (MSKCC), are doing this study to compare two methods of treating pain during and after major gynecological surgery. The two methods are called patient-controlled epidural analgesia (PCEA) and patient-controlled intravenous analgesia (PCA). PCA is the standard of care for women having major gynecological surgery. We are going to compare PCEA to PCA to see if PCEA will improve recovery after major gynecologic surgery.
PCEA is a well established method used to ease pain in many settings such as during childbirth and bowel surgery. There have been several studies showing that PCEA is as good as and sometimes better for pain relief than PCA. PCEA may help the bowel work better by preventing ileus after surgery. However, this has never been looked at in women having major gynecologic surgery. This study will also look at whether preventing this ileus will lead to patients going home or returning to regular activities sooner.
Detailed description
The objective of this study is pain at rest and coughing in addition to determine the effect of intraoperative and postoperative thoracic patient-controlled epidural analgesia (PCEA) compared to postoperative intravenous patient-controlled analgesia (PCA) on postoperative recovery parameters, such as time to potential discharge and resumption of intestinal function after major open gynecologic surgery. The population included in this study will be women undergoing a laparotomy for major abdominal or pelvic surgery by the gynecology service. There will be a total of 240 women recruited for this study, with an accrual rate of 5 to 10 patients per month. This study will be a randomized controlled clinical trial. Subjects will be randomized to either general anesthesia with postoperative intravenous patient controlled analgesia (control group) or general anesthesia with intraoperative thoracic epidural anesthesia and postoperative thoracic patient-controlled epidural analgesia (treatment group). This study will not be blinded because of the ethical issues with placing a "sham" epidural catheter in half of the study participants. These patients will be followed prospectively and relevant postoperative parameters will be measured in both groups and compared. This study will address the potential benefits of epidural analgesia on multiple measurements of postoperative recovery. This study will address the potential benefits of epidural analgesia on multiple measurements of postoperative recovery. The primary outcome of interest in this study is pain at rest and when coughing. The secondary outcome is the time to potential discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (PCEA) | Active comparator | Drug: patient-controlled epidural analgesia (PCEA)patient-controlled epidural analgesia PCEA involves having an epidural catheter placed before surgery.The epidural catheter will be used during surgery to give drugs, such as morphine and a local anesthetic bupivacaine, which will help control pain. After surgery, a constant flow of pain-reducing medicine, such as morphine, will be given through the catheter. This is controlled by the patient. |
| PCA | Active comparator | Drug: patient-controlled intravenous analgesia (PCA)patient-controlled intravenous analgesia (PCA) PCA involves placing a tube into the patient's vein after surgery. The tube is connected to a pump that is controlled by the patient. The pump holds a medicine, such as morphine, that eases pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women undergoing a laparotomy for major abdominal or pelvic surgery by the gynecology service
- Patients 18 years or older
- Patients who have signed an approved informed consent form
Key exclusion criteria (15 listed)
- Patients undergoing total pelvic exenteration
- Patients undergoing laparoscopy only
- Patients undergoing palliative surgery for bowel obstruction
- Patients undergoing emergent operations
- Inability to take oral intake
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 |
|---|---|---|
| patient-controlled epidural analgesia (PCEA)During the consent process you will be given a patient data sheet to assess your baseline pain and itchiness. While in the hospital you will be given a patient data sheet to fill out information regarding pain, nausea, when you passed gas, and when you ate food. This will be done once a day by a research assistant or by the research investigators. | Drug | (PCEA) |
| patient-controlled intravenous analgesia (PCA)During the consent process you will be given a patient data sheet to assess your baseline pain and itchiness. While in the hospital you will be given a patient data sheet to fill out information regarding pain, nausea, when you passed gas, and when you ate food. This will be done once a day by a research assistant or by the research investigators. | Drug | PCA |
Primary outcome
Pain at rest and when coughing - assessed by visual analog scale (VAS)
Time frame: conclusion of the study
12 secondary outcomes
The time (in days) to potential discharge based on documentation of all of the discharge criteria below: Toleration of diet (as assessed by tolerating clear fluid diet for 24 hours without nausea requiring antiemetic or vomiting within 4 hours of a meal)
Time frame: conclusion of the study
Passing of flatus (as assessed by patient)
Time frame: conclusion of the study
Absence of fever for 24 hours
Time frame: conclusion of the study
Actual length of stay in hospital (in days). This may be different from actual time of potential discharge as met by criteria in primary outcome
Time frame: conclusion of the study
Nausea (yes/no)
Time frame: conclusion of the study
Vomiting (number episodes per day)
Time frame: conclusion of the study
Use of anti-emetics per day (yes/no)
Time frame: conclusion of the study
Pruritus per day (yes/no)
Time frame: conclusion of the study
Overall patient satisfaction - questionnaire
Time frame: conclusion of the study
Postoperative complications - complications occurring within 30 days of surgery as assessed by MSKCC surgical secondary events grading system
Time frame: conclusion of the study
Complications related to intraoperative events (anesthetic and surgical)
Time frame: conclusion of the study
Complications arising from analgesic techniques
Time frame: conclusion of the study
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 10 Nov 2008.
- (Memorial Sloan-Kettering Cancer Center)Link provided by the sponsor.
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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.
Nadeem R. Abu-Rustum, M.D. principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Postoperative Pain, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2008. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain at rest and when coughing - assessed by visual analog scale (VAS) (time frame: conclusion of the study). 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 10 Nov 2008.