Original research
A randomized controlled trial of early oral analgesia in gynecologic oncology patients undergoing intra-abdominal surgery

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Abstract

OBJECTIVE:

To evaluate the safety and efficacy of early oral analgesia after intra-abdominal surgery in gynecologic oncology patients.

METHODS:

Over a 2.5-year period, 227 gynecologic oncology patients undergoing intra-abdominal surgery were enrolled in a randomized controlled trial of early oral versus traditional parenteral analgesia. All patients initially received parenteral morphine via a patient-controlled analgesia (PCA) pump with a basal dose of 0.5 mg/h and a PCA dose of 1 mg with a 10-minute lockout. On the first postoperative day, all patients began a clear liquid diet, which was advanced as tolerated. Patients allocated to early oral analgesia were switched from parenteral to oral morphine. They received a scheduled dose of 20 mg every 4 hours with an additional dose of 10 mg every 2 hours as needed for breakthrough pain. Patients allocated to traditional parenteral analgesia continued to receive parenteral morphine via a PCA pump with basal and PCA doses. On the second postoperative day, the scheduled oral and basal parenteral doses were discontinued. The oral and parenteral PCA doses were continued until 24 hours before discharge, at which time the patient was switched to oxycodone 5 mg/acetaminophen 325 mg.

RESULTS:

There were no significant differences among the groups in any demographic or clinical indices, including age, case distribution, surgery length, blood loss, time to return of bowel function, length of hospital stay, pain, sedation, and satisfaction scores, and incidence of nausea, vomiting, or major postoperative complications.

CONCLUSIONS:

Early oral analgesia in gynecologic oncology patients undergoing intra-abdominal surgery is safe and efficacious.

Section snippets

Materials and methods

This trial was approved by the Institutional Review Boards at the State University of New York at Stony Brook, and informed consent was obtained from all patients. All gynecologic oncology patients undergoing nonlaparoscopic intra-abdominal surgery were eligible to participate. Patients who were either unable to use a PCA pump or intolerant of morphine were excluded. After induction of general anesthesia, patients were randomized using a computer-generated random number list.

All surgical

Results

Between July 1, 1997 and January 25, 2000, 227 patients enrolled in this trial, representing 43% of eligible patients. Each of the remaining patients declined to participate for personal reasons. Seven patients were non-evaluable, four in the early oral analgesia group and three in the traditional parenteral analgesia group. These seven patients were transferred to the intensive care unit postoperatively and were unable to receive any oral intake.

Table 2, Table 3 summarize the demographic and

Discussion

The management of the postoperative patient has been dominated by surgical dogma derived without the benefit of scientific inquiry. Because of fears that early initiation of oral intake would lead to serious adverse consequences, patients have been prohibited from taking anything orally until they provided satisfactory evidence of bowel function by passing flatus and/or having a bowel movement. Consequently, administration of postoperative pain medication has been limited to parenteral routes.

References (17)

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    It should be mentioned that the advantage of including a fast-acting intravenous step into the titration procedure has been questioned several times in the past. Recently, Pearl et al. provided evidence that early oral analgesia in gynecologic oncology patients undergoing intra-abdominal surgery is as safe and efficacious as intermediate intravenous PCA.109 On the other hand, one must always keep in mind that some cancer patients with a long history of opioid use can develop serious postoperative problems if their previous opioid consumption is not taken into consideration, as demonstrated in a case report by Heid et al., where early PCA revealed a daily intravenous morphine need of 600–800 mg.110

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