Clinical trial NCT00136682: Patient-Controlled Epidural Analgesia (PCEA) for Patients Who Have Had Major Open Gynecologic Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: Major abdominal or pelvic surgery
Patient-Controlled Epidural Analgesia (PCEA)
Length of hospital stay after surgery
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2005-08-29
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: Pain at rest and when coughing - assessed by visual analog scale (VAS)
timeFrame: conclusion of the study
Secondary outcomes:
measure: 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)
timeFrame: conclusion of the study
measure: Passing of flatus (as assessed by patient)
timeFrame: conclusion of the study
measure: Absence of fever for 24 hours
timeFrame: conclusion of the study
measure: 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
timeFrame: conclusion of the study
measure: Nausea (yes/no)
timeFrame: conclusion of the study
measure: Vomiting (number episodes per day)
timeFrame: conclusion of the study
measure: Use of anti-emetics per day (yes/no)
timeFrame: conclusion of the study
measure: Pruritus per day (yes/no)
timeFrame: conclusion of the study
measure: Overall patient satisfaction - questionnaire
timeFrame: conclusion of the study
measure: Postoperative complications - complications occurring within 30 days of surgery as assessed by MSKCC surgical secondary events grading system
timeFrame: conclusion of the study
measure: Complications related to intraoperative events (anesthetic and surgical)
timeFrame: conclusion of the study
measure: Complications arising from analgesic techniques
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nadeem R. Abu-Rustum, M.D.
role: PRINCIPAL_INVESTIGATOR
References: