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Departments of *Anesthesiology & Pain Management and
Plastic Surgery, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas
Address correspondence and reprint requests to Paul F. White, MD, PhD, Department of Anesthesiology & Pain Management, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9068. Address e-mail to paul.white{at}utsouthwestern.edu.
| Abstract |
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| Introduction |
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An earlier study demonstrated that the combination of ondansetron and acustimulation was more effective than ondansetron alone in preventing PONV (3). Although a meta-analysis by Lee and Done (12) confirmed that acustimulation was effective in preventing PONV, the optimal use of this nonpharmacologic technique has not been studied (13). In a preliminary multicenter study, use of transcutaneous electrical acustimulation reduced nausea but not vomiting when administered as the sole prophylactic therapy after laparoscopic surgery (14). However, more recent studies have reported a reduction in both nausea and emesis (3,15). Although it was suggested that preoperative versus postoperative acupoint stimulation made no difference in the incidence of vomiting within the first 6 h after major gynecologic surgery (16), this study was terminated prematurely.
Therefore, we designed a sham-controlled study to test the hypothesis that the timing of acustimulation with the ReliefBand® (Woodside Biomedical Systems, Inc., Carlsbad, CA) during the perioperative period influenced its efficacy when used as part of a multimodal regimen for antiemetic prophylaxis. The primary objective was to compare stimulation with the ReliefBand® before and/or after major plastic surgery procedures with respect to its effect in preventing PONV. Secondary objectives were to assess the effect of acustimulation therapy on the need for rescue antiemetic drugs and resumption of normal activities of daily living.
| Methods |
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Patients who had taken any antiemetic medication within 24 h before the operation, were pregnant or menstruating, had a permanent cardiac pacemaker, had previous experience with acustimulation therapy, or had experienced nausea, vomiting, or retching within 24 h before surgery were excluded. Any history of PONV or motion sickness or active smoking was noted. In the day-surgery unit (DSU), patients completed a preoperative verbal rating scale (VRS) for nausea, with 0 = none to 10 = worst imaginable. An active (Groups 1 and 3) or sham (Group 2) ReliefBand® device was applied at the P6 acupoint of the nondominant arm for 30 min before the patient was transferred from the DSU to the OR. Patients were instructed in the correct placement of the device and told to apply it snugly around the wrist to avoid inadvertent displacement. Although the ReliefBand® devices used in all three groups were identical in appearance, the sham devices were electronically altered by the manufacturer to allow them to simulate the active unit without actually delivering electrical current to the metal electrodes in contact with the surface of the skin.
Before either the active or sham device was applied, the P6 placement area on the plantar aspect of the wrist was carefully cleaned with an alcohol swab, followed by the application of a hypoallergenic conductivity gel. The controller setting on the device was initially turned to Setting 3 unless the patient complained of discomfort at the P6 acupoint, in which case it was reduced to Setting 2. To minimize bias resulting from the presence or absence of the electrical stimulation, patients were told that the acustimulation device produces a tingling sensation that they "might or might not feel." The device was removed when the patient entered the OR.
All patients received a standardized general anesthetic technique consisting of propofol 1.52.5 mg/kg and sufentanil 0.3 µg/kg IV for induction, rocuronium 0.6 mg/kg IV for tracheal intubation, and sevoflurane 0.75%3% end-tidal concentration in an air/oxygen mixture in combination with a sufentanil infusion (0.10.2 µg · kg1 · h1) and rocuronium 0.0750.15 mg · kg1 · h1 for maintenance of anesthesia. Residual neuromuscular blockade at the end of surgery was reversed with a combination of neostigmine 4060 µg/kg and glycopyrrolate 510 µg/kg IV. All patients also received antiemetic prophylaxis with ondansetron 4 mg IV at the end of surgery. Upon patients arrival in the postanesthesia care unit (PACU), a nurse specifically trained in the proper positioning of the ReliefBand® placed an active (Groups 2 and 3) or sham (Group 1) device at the P6 acupoint of the nondominant arm at the same setting that was used before surgery. All patients were instructed to wear the acustimulation device for 72 h after surgery except when bathing and sleeping. It was recommended that the device be activated every 24 h during the awake hours and before consumption of opioid-containing analgesic medication. An antiemetic rescue drug (metoclopramide 10 mg IV) was administered only if the patient complained of persistent nausea (with a nausea VRS >3) lasting longer than 15 min or experienced repeated episodes of vomiting or retching.
The type and duration of the plastic surgery procedures, as well as the length of stay in the PACU and DSU, were recorded. All inpatients were started on patient-controlled analgesia with morphine (1-mg IV boluses) before discharge from the PACU. Postoperative nausea was assessed by a blinded observer with the 11-point VRS upon admission to the PACU, at 15 and 30 min after the device was reapplied, and subsequently at 30-min intervals until the patient was discharged from the PACU. VRS nausea scores >3 on 2 consecutive assessments were considered to indicate clinically significant nausea. All episodes of vomiting and retching, as well as the need for rescue antiemetic medications, were recorded in a patient diary during the 72-h postoperative follow-up period. Complete responses were defined as no vomiting or retching (i.e., emesis) or need for a rescue antiemetic to treat persistent nausea (VRS >3) within the first 24 h after surgery.
For the outpatients (n = 30), home discharge criteria (home readiness) required that the patient be fully awake and oriented, have stable vital signs while standing, be able to walk without assistance, and not be experiencing any active side effects (e.g., pain, dizziness, or emetic symptoms) (5,10). Postoperative pain management consisted of oral opioid-containing analgesics. Follow-up visits to the postsurgical ward and/or telephone calls were performed at 24- and 72-h intervals after surgery by an investigator (who was unaware of the treatment group to which the patient was assigned) to inquire about any emetic symptoms and to evaluate the patients satisfaction with the quality of recovery and antiemetic management by using a VRS, with 0 = poor recovery to 100 = excellent recovery and 0 = very dissatisfied to 100 = highly satisfied, respectively. At the time of the 24- and 72-h follow-up evaluations, patients were queried about their continued use of the acustimulation device, as well as their resumption of a normal diet, physical activities (e.g., ambulating and lifting), and a regular sleep pattern.
Assuming that 50% of these patients would develop nausea, vomiting, or both after plastic surgery under general anesthesia with ondansetron (4 mg IV) alone for antiemetic prophylaxis (3), a minimum sample size of 30 patients was determined by an a priori power analysis to provide an 80% power of detecting an absolute difference of 25% between treatment groups (i.e., a reduction from 50% to 25%) with an
of 0.05. Nonparametric analysis was used to compare nausea VRS scores, number of emetic episodes, and antiemetic use among the three study groups. The
2 test was used to compare the proportion of patients complaining of nausea (i.e., consecutive VRS nausea scores >3), having one or more emetic episodes, and receiving rescue antiemetic medication. In cases in which expected frequencies were small, Fishers exact test was used. The times to the first emetic event and to rescue medication were analyzed with log-rank test statistics. The times to when 25% of the patients in each group were judged to have failed the prophylactic antiemetic therapy (i.e., required a rescue antiemetic drug for persistent nausea or repeated emesis) were determined by the Kaplan-Meier method. Data analysis was performed with NCSS Version 6.0 (NCSS, Kaysville, UT). Data are presented as means ± sd, medians (interquartile ranges), numbers, or percentages, with P values <0.05 considered statistically significant.
| Results |
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The complete response rate was significantly higher in the perioperative (versus preoperative) group during the 4 to 24 h after surgery (Table 2). The percentages of patients who were able to resume a normal diet and sleep pattern on the first postoperative day did not differ significantly among the three groups. However, more patients in the perioperative group were able to resume physical activities at 24 h after surgery (21%, versus 3% in the preoperative group). Of note, a larger proportion of the patients undergoing plastic surgery procedures in the perioperative group were discharged home on the day of surgery (41%, versus 20% in the preoperative group). None of the patients were readmitted to the hospital because of intractable PONV. In the subset of patients discharged home on the day of surgery, the average length of stay in the DSU was significantly reduced in the perioperative (versus preoperative) group (114 ± 41 min versus 164 ± 50 min, respectively) (Table 2). Finally, the postoperative and perioperative groups had improved patient satisfaction with their quality of recovery and antiemetic therapy compared with the preoperative group (Table 2).
The Kaplan-Meier estimates (Fig. 1) suggested that the median time intervals for 25% of the patients to develop symptoms requiring antiemetic rescue therapy were 30, >240, and >240 min in Groups 1, 2, and 3, respectively. No local (cutaneous) side effects were reported at the acustimulation site by any patient in the three treatment groups during the 72-h study period.
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| Discussion |
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Previous studies have demonstrated the antiemetic effectiveness of stimulation at the P6 acupuncture point compared with a standard antiemetic drug (e.g., metoclopramide, droperidol, or ondansetron) (3,15,1922). Although all three treatment groups probably received some benefit from the presence of acupressure at the P6 acupoint, electrical stimulation clearly produced additional benefit when administered in the postoperative period. Interestingly, Kotani et al. (23) reported, in a sham-controlled study, that perioperative intradermal (nonelectrical) acupuncture stimulation in a paravertebral distribution also reduced nausea and vomiting after major abdominal surgery. However, these authors did not evaluate the relative benefits of preoperative versus postoperative treatments on patient outcomes, and the apparent antiemetic action may have been related to an opioid-sparing effect. The study by Yentis and Vashisht (16) examined the antiemetic effect of acupuncture stimulation when administered before, during, or after surgery. Given the brief duration of the treatment sessions (five minutes), it is hardly surprising that the authors found no differences in the incidences of vomiting in the first six hours after major lower abdominal surgery. Their failure to examine the effect of the treatments on postoperative nausea may also have contributed to their negative findings. We are unaware of any other clinical studies that have systematically examined the antiemetic and antinausea efficacy of preoperative versus postoperative acustimulation.
Another controversy in this field of research relates to the relative effectiveness of acustimulation on nausea and vomiting (or emesis). In a preliminary multicenter study involving use of the ReliefBand® during the postoperative period, Zarate et al. (14) found a significant antinausea effect but failed to demonstrate a significant decrease in the incidence of emesis. These findings were confirmed in a more recent study by Rusy et al. (24) involving the use of electroacupuncture in children. However, a recent sham-controlled study by Gan et al. (15) found a reduction in both nausea and vomiting when acustimulation was administered with a Hans transcutaneous electrical stimulating device in the postoperative period. The ReliefBand® acustimulation device appears to be more effective for preventing than for treating PONV when used in combination with an antiemetic drug (3,25). The current study also confirms that the primary benefit of electroacustimulation was in reducing nausea and in improving patient satisfaction during the postoperative period.
Methodologic problems are common with clinical studies involving the use of nonpharmacologic antiemetic therapies. As reported in previous studies (3,25), patients receiving the active ReliefBand® devices after surgery are more likely to be able to detect the tingling sensation produced at the P6 acupoint, and therefore patient bias may have contributed to the greater antiemetic efficacy of acustimulation in the groups receiving postoperative (versus preoperative) stimulation. Another possible deficiency in the study design related to the fact that there was no perioperative sham group. Because the efficacy of the ReliefBand® has been demonstrated in earlier sham-controlled studies involving similar high-risk patient populations (3,14), it was not considered necessary to include this group in this study. Although acupressure may contribute to the antiemetic efficacy of the ReliefBand® device, this effect would have minimized the differences among the three treatment groups. Because differences in postoperative opioid analgesic use can also contribute to differences in PONV, the pain management regimen was standardized for all patients. A final criticism of our study design related to the mix of plastic surgery procedures included in this study. Although the distribution of cases was similar in all three treatment groups (Table 1), the ability of more patients in the perioperative group to resume physical activities at 24 hours after surgery may reflect the fact that more patients in this treatment group were discharged home on the day of surgery.
As a result of the traditionally frequent incidence of PONV in this plastic surgery population, ondansetron (4 mg IV) was administered to all patients (1,12). Ethical concerns raised by the surgical and anesthesia staff prevented us from including a study group receiving no antiemetic prophylaxis. Increasing interest in the use of acustimulation techniques is related in part to the recent controversy regarding the use of small-dose droperidol for antiemetic prophylaxis (6,8,9). Analogous to earlier P6 acupoint stimulation studies in children (19,20,24) and adults (3,15,21,22), this clinical investigation confirms that the ReliefBand® is an effective adjunct to antiemetic drugs for preventing symptoms related to PONV when administered after surgery. Although the ReliefBand® device has been reported to enhance the antiemetic efficacy of ondansetron when administered in the postoperative period (3), 18%20% of these high-risk patients still required a rescue antiemetic to control their emetic symptoms after surgery. These data would suggest that the addition of a second antiemetic drug (e.g., droperidol or dexamethasone) is probably indicated to minimize PONV after these highly emetogenic surgical procedures (26).
In conclusion, use of the ReliefBand® acustimulation device after plastic surgery appeared to enhance the antiemetic efficacy of ondansetron. However, the device is significantly less effective when applied only in the preoperative period.
| Footnotes |
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Accepted for publication August 23, 2004.
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