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

NCT00136682 | Completed Phase 3

• 1 other identifier: 04-091
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Major abdominal or pelvic surgery; Patient-Controlled Epidural Analgesia (PCEA); Length of hospital stay after surgery

Outcome Measures

Primary Outcomes (1)

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

  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)

  conclusion of the study

• Passing of flatus (as assessed by patient)

  conclusion of the study

• Absence of fever for 24 hours

  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

  conclusion of the study

• Nausea (yes/no)

  conclusion of the study

Study Arms (2)

(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.

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.

Drug: patient-controlled intravenous analgesia (PCA)

Interventions

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.

(PCEA)

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.

PCA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• (Memorial Sloan-Kettering Cancer Center)

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Nadeem R. Abu-Rustum, M.D.

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 29, 2005
• Study Start: August 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: November 10, 2008

Record last verified: 2008-11

Locations

US (1)