Ferguson, S.E., Malhotra, T., Seshan, V.E., Levine, D.A., Sonoda, Y., Chi, D.S., . . . Abu-Rustum, N.R. (2009). A prospective randomized trial comparing patient-controlled epidural analgesia to patient-controlled intravenous analgesia on postoperative pain control and recovery after major open gynecologic cancer surgery. Gynecologic Oncology, 114(1), 111–116.

DOI Link

Study Purpose

To evaluate the effect of bupivacaine-morphine patient-controlled epidural analgesia (PCEA) versus IV morphine patient-controlled analgesia (PCA) on pain at rest and during coughing and on time to potential discharge, length of hospital stay, nausea, vomiting, pruritus, and overall patient satisfaction

Intervention Characteristics/Basic Study Process

Control group received IV morphine PCA 1 mg/hour basal rate with rescue dose of 1 mg every 10 minutes as needed by PCA. The women in the treatment arm had thoracic epidural morphine-bupivacaine PCEA 100 mcg/ml with 0.05% bupivacaine basal rate 4 mg/hour with rescue boluses of 4 ml every 30 minutes. In both treatment arms, therapy was titrated to ensure adequate pain control with treatment of any side effects.

Sample Characteristics

  • The sample was composed of 135 patients.
  • All patients were 18 years old or older. In the PCEA group, mean patient age was 57 years. In the PCA group, mean patient age was 55 years.
  • All participants were female.
  • All participants were women who had undergone abdominal surgery by laparotomy for treatment of a gynecologic disorder. More than 75 of participants had a diagnosis of gynecologic cancer.

Setting

  • One site
  • Inpatient cancer center
  • Memorial Sloan-Kettering Cancer Center, New York City

Study Design

Prospective randomized trial

Measurement Instruments/Methods

Visual analog scale (VAS), a 10-point pain scale regarding side effects

Results

  • For the first three postoperative days, the mean VAS scores reflecting pain while coughing were significantly lower (P < 0.05) in the PCEA arm than were the mean VAS scores in the PCA group.
  • On Day 1, the mean at-rest pain score was 3.3 in the PCEA group and 4.3 in the PCA group (P = 0.01).
  • For the first six days, women treated with PCEA had significantly less pain (P < 0.003) at rest and while coughing than did women in the PCA group.
  • Time to discharge did not differ significantly between the two groups.
  • Compared to women in the PCEA group, significantly fewer women in the PCA group had pruritus.
  • Investigators noted no significant differences in the rates of nausea during the first two days.
  • Significantly more women had postoperative urinary retention in the PCEA group than did women in the PCA group.
  • Over the first six postoperative days, global satisfaction scores showed that women in the PCEA group were significantly more satisfied with their pain therapy than were women in the PCA group.

Conclusions

For the first six postoperative days, women treated with PCEA morphine-bupivacaine had less pain at rest and during coughing than did women treated with conventional IV PCA. The incidence and severity of adverse effects were not significantly different between groups.

Limitations

  • This study had a risk of bias due to no blinding.
  • According to calculations, the sample size should have been 120 per arm; however, the study had a sample size of 135 total. Therefore, lack of power is a limitation of the study.

Nursing Implications

Nurses must be knowledgeable about postoperative care, the complications associated with abdominal surgery, and optimization of perioperative PCEA.