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


Phase 3
18 Years
N/A
Not Enrolling
Female
Postoperative Pain

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

conclusion of the study

Safety Issue:

No

Principal Investigator

Nadeem R. Abu-Rustum, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

04-091

NCT ID:

NCT00136682

Start Date:

August 2004

Completion Date:

July 2007

Related Keywords:

  • Postoperative Pain
  • Major abdominal or pelvic surgery
  • Patient-Controlled Epidural Analgesia (PCEA)
  • Length of hospital stay after surgery
  • Pain, Postoperative

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021