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NCT Number: NCT00136682

Patient-Controlled Epidural Analgesia (PCEA) for Patients Who Have Had Major Open Gynecologic Surgery

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Pain at rest and when coughing - assessed by visual analog scale (VAS)

    Time frame: conclusion of the study

Secondary outcomes

  1. 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

  2. Passing of flatus (as assessed by patient)

    Time frame: conclusion of the study

  3. Absence of fever for 24 hours

    Time frame: conclusion of the study

  4. 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

  5. Nausea (yes/no)

    Time frame: conclusion of the study

  6. Vomiting (number episodes per day)

    Time frame: conclusion of the study

  7. Use of anti-emetics per day (yes/no)

    Time frame: conclusion of the study

  8. Pruritus per day (yes/no)

    Time frame: conclusion of the study

  9. Overall patient satisfaction - questionnaire

    Time frame: conclusion of the study

  10. Postoperative complications - complications occurring within 30 days of surgery as assessed by MSKCC surgical secondary events grading system

    Time frame: conclusion of the study

  11. Complications related to intraoperative events (anesthetic and surgical)

    Time frame: conclusion of the study

  12. Complications arising from analgesic techniques

    Time frame: conclusion of the study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Aug 29, 2005
Registry last updated
Nov 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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