Recall of Risks Following Labor Epidural Analgesia

Authors

Paul J. Affleck MD

David B. Waisel MD

Jeffrey M. Cusick MD

Tama Van Decar MD

This work was performed at Wilford Hall Medical Center, Lackland Air Force Base, Texas. The views expressed are those of the authors and do not reflect the views of the United States Air Force or any other branch of the Department of Defense or the United States Government.

Running Title

Recall of Labor Epidural Analgesia Risks

Key Words

informed consent, labor analgesia, obstetric analgesia, prenatal care, risks of anesthesia

Abstract

Study objective: To ascertain patients' recall of the risks of labor epidural analgesia from an informed consent discussion given during active labor.

Study design: Survey analysis following an intervention.

Setting: Labor and delivery unit of a tertiary care teaching hospital

Patients: 101 parturients in active labor

Interventions: Patients were given a standardized discussion of the risks of labor epidural analgesia.

Measurements: Within 24 hours of the informed consent discussion, patients were first asked to recall risks, and then asked to identify risks from a list of true and false risks,

Main results: Patients recalled 2.0 ± 1.3 risks (mean ± SD), with 12% recalling at least 4 risks, 37% recalling at least 3 risks, 66% recalling at least 2 risks and 87% recalling at least 1 risk. There was no difference in level of recall between primiparas and multiparas and patients with mild or moderate pain and severe pain.

Conclusions: Recall of risks by parturients is similar to the recall of risks by other patients and does not appear to be affected by parity or the reported level of pain.

Introduction

Each year 105 million women in the United States receive epidural analgesia for labor pain 1,2. Anesthesiologists must obtain informed consent after labor has begun for many of these patients. These discussions are often disturbed by painful contractions and are met with multiple reactions, including anguish, indifference, cursory acknowledgment, and an eagerness to proceed with the epidural. In addition to the pain of labor, this process may be handicapped by the emotional upheaval associated with childbirth, by lack of sleep, and by a limited amount of time for the patient to think about what has been discussed,

Real and successful participation in the informed consent process, then, is difficult 3,9. One component of informed consent is the substantial understanding of the risks and benefits of the proposed procedure and alternatives by the patient. We undertook this study to determine the ability of laboring patients to recall anesthetic risks when given a standardized list of risks associated with epidural analgesia.

Materials and Methods

After Institutional Review Board approval was obtained, ASA status 1 and 2 parturients in active labor who requested epidural analgesia and had not received any form of intravenous or oral pain medication were given a standardized oral discussion of anesthetic risks prior to the placement of an epidural catheter. This discussion was performed by anesthesia residents specifically trained by the investigators. Parturients were informed about the risks in the following order: infection, bleeding, nerve damage, urinary retention, high spinal block, block failure, nausea and vomiting, respiratory depression, pruritis, intravenous injection (with cardiovascular collapse), post-dural puncture headache, local anesthetic toxicity (potential seizure) and hypotension. Patients were then given the opportunity to discuss any concerns about the epidural analgesia. The patient's pain level was documented by a standard 10 cm visual analogue scale from 0 to 100. Demographic data obtained included her age, parity, and attendance at prenatal classes.

The patients were surveyed during routine postpartum rounds the day following delivery. All patients were interviewed within 24 hours of the informed consent process and no patients had received any form of intravenous or oral narcotic or sedation since admission for delivery. Patients were first asked to verbalize any of the risks of epidural analgesia that they could recall. Following this, patients were given a printed list of 8 risks, 5 of which were real and 3 of which were false, and were asked to identify those risks which they could recall being discussed with them prior to epidural placement.

True and false risks were presented in the list as follows: constipation, headache, hypotension, itching, muscle spasm, nausea/vomiting, nerve damage, rash.

The number of risks spontaneously recalled and the number of true and false risks identified were analyzed descriptively. The number of risks recalled by multiparous and primiparous patients were compared using a Mann-Whitney Rank Sum test. The number of risks recalled by patients with mild (VAS < 30) or moderate pain (VAS ? 30 and < 70) were compared to patients with severe pain (VAS ? 70) using a one-way ANOVA test. A Pearson Product Moment Correlation was used to determine any correlation between the identification of real risks and false risks.

Results

Standardized consent was given to 101 parturients in active labor of which 49 were primiparous and 52 were multiparous (Table 1). The average age of the patients was 26 ± 3.7 years and ranged from 17 to 38 years. All patients who received the standard preoperative consent received epidural analgesia and participated in the post-parturn survey. Forty-two percent of all patients attended the free prenatal classes offered to all parturients at our institution.

All patients recalled both the informed consent discussion and the placement of the epidural. Patients recalled an average of 2.0 ± 1.3 risks, with 13 (13%) patients recalling 0 risks, 22 (22%) recalling 1 risk, 29 (29%) recalling 2 risks, and 25 (25%) patients recalling 3 risks (Figure 1). Of those patients who recalled only one risk (22%), 14 (64%) recalled post-dural puncture headache, 3 (14%) recalled nerve damage, and 3 (14%) recalled pruritis. For all patients, the most commonly recalled risks were postdural puncture headache, nerve damage, pruritis, and nausea and vomiting (Table 2). When prompted with a list, patients identified 3.5 ± 1.1 (mean ± SO) true risks out of 5 present and 0.7 ± 0.9 false risks out of 3 present. All five true risks were identified by more than 50% of the parturients (Table 3). No false risk was identified more than 28% of the time. For all patients, there was no linear correlation between identifying real risks and false risks from the list (correlation coefficient 0.36).

The differences in the number of risks recalled by primiparas and multiparas was not statistically significant (Figure 2). When prompted with the list, the differences in the number of true and false risks identified by primiparas and multiparas were not statistically significant (Table 1). The rate of recall of specific risks for the primapara and multipara paralleled the rate of recall for all the women as shown in Tables 2 and 3, There was no linear correlation between identifying real risks from a list and identifying factitious risks (correlation coefficient 0,37).

VAS scores ranged from 0 to 100 with a mean of 78 ± 25. There was no statistical difference of recall of risks between patients with mild (VAS < 30) or moderate pain (VAS ? 30 and < 70) and those with severe pain (VAS ? 70) (Figure 3).

Discussion

The responsibility of a physician to obtain informed consent is an expression of societys' belief that patients have the right to self-determination. A valid informed consent process depends in part on substantially informing the patient about the risks and benefits of the procedure. Successfully educating the laboring parturient about the risks of epidural analgesia is often thought to be particularly difficult due to pain, lack of sleep and emotional upheaval. Our study questions such assumptions.

While the rate of recall of risks in this study may not be completely satisfactory, other studies in obstetric and non-obstetric patients in a variety of situations have shown similar levels of recall. Swan and Borshoff found that 67% of primiparas could recall at least one risk of epidural analgesia 36 to 48 hours postpartum3. Cassileth et al found that only 55% of cancer patients could list even one of the major risks of chemotherapy one day after giving consent4, Muss reported that less than 50% of chemotherapy patients could recall a potentially lethal complication while they were receiving therapy 5. Priluck et al reported that only 23% of patients could correctly recall the risks of the elective retinal detachment surgery two to eleven days after giving informed consent for the procedure 6 . Leeb et al reported that within seven days of cosmetic surgery, patients having elective surgery recalled 29% of the risks presented and patients having emergency surgery recalled 38% of the risks presented 7. Given this background, it does not appear that the recall of risks of labor epidural analgesia is that much worse than in many other situations.

The degree of pain a patient is experiencing is often thought to affect a patient's ability to substantially participate in the informed consent discussion". We found no difference between patients with low or moderate pain scores and those with high pain scores, implying that pain may be less of an issue than previously thought. This may have significance not only for labor epidural analgesia, but also for other situations that involve obtaining informed consent in the face of pain. In addition, we found no statistical difference in the level of recall between primiparous and multiparous parturients, suggesting that familiarity with the childbirth experience may not be a significant factor in the ability to recall specific risks.

The role of the prenatal class in this study should be examined, Prenatal education in epidural analgesia has been shown to increase the recall of risks in the postpartum period3. Such classes, however, are not well attended, and we desired to examine the informed consent process as it occurred in the parturient in active labor 8,9. Less than half of our patients attended the free prenatal classes offered at our institution, which has no formalized discussion of the risks of epidural analgesia. However, since these classes were not standardized, we cannot be certain that epidural analgesia was not discussed in one format or another. Since there was no difference in recall between those who attended a prenatal class and those who did not, we believe that the classes had no impact on the recall of risks in our study, as a whole and between groups.

The ability of patients to recall risks discussed during labor is similar to the reported ability of other non-laboring patients to recall risks and is not affected by pain or experience. The implications of this are unclear, Certainly recall of risks does not thoroughly assess the appropriate use and understanding of the risk discussion at the moment of decision. Nonetheless, recall is one way of evaluating the success of the discussion of risks and our results refute commonly held assumptions that imparting such information is more difficult in the laboring parturient. Such results may then require anesthesiologists to redouble their efforts to substantially achieve informed consent in the laboring parturient, rather than considering it an impractical and impossible task.

This study should not be interpreted as suggesting that the obstetrical patient should receive an extensive list of all imaginable risks as part of the informed consent discussion. Anesthesiologists should remember that the goal of informed consent is to provide the kind and quality of information that will fulfill the needs of the individual person and not to provide a lengthy list of all the possible risks 12. A more focused discussion which tailors the informed consent to the individual parturient may better serve her needs. Beauchamp explains that "the ideal of complete disclosure of all possible relevant knowledge needs to be replaced by a more acceptable account of how patients and subjects understand relevant information. Merely because one's actions fail to be fully informed, voluntary or autonomous is no indication that they are never adequately informed or autonomous 10.

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