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*Outcomes Research® Institute and Department of Anesthesiology, University of Louisville, Louisville, Kentucky; and
Ludwig Boltzmann Institute, University of Vienna, Vienna, Austria
Address correspondence and reprint requests to Daniel I. Sessler, MD, Outcomes Research® Institute, 501 E. Broadway, Ste. 210, Louisville, KY 40202. Address e-mail to sesslerdan{at}aol.com
| Abstract |
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of 0.05. Minute sphere treatment at the Neiguan, Zusanli, Sanyinjiao, and Gongsun points thus failed to provide analgesia after abdominal surgery. Minute sphere therapy is a form of acupuncture. We tested whether minute spheres placed on three acupressure points relevant to abdominal surgery reduced pain and morphine requirements after abdominal surgery. Treatment and control patients received a similar covering. Neither pain nor morphine requirements were different between the groups.
| Introduction |
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Oriental medicine has been used to treat pain for more than 4000 yr (2). These treatments are based on meridian lines that describe the flow of energy through the human body. Across these putative energy flow pathways are several station points. Stimulation of these areas is thought to beneficially influence the patterns of energy flow for the associated meridian (3,4). The putative beneficial effects of acupuncture, for example, are mediated by stimulation of these points.
Common oriental medical techniques include acupuncture, moxibustion, acupressure, and Chinese herbs (5). An analgesic method that has been used for more than 2000 years is application of minute spheres to stimulate acupressure points along relevant meridians. The small spheres can be made of wood, stone, or metal. Among the benefits of this technique are convenience and low cost. Furthermore, the treatments are noninvasive and rarely produce complications.
Minute sphere acupressure remains popular in hospitals of oriental medicine in Japan to improve muscle pain and stiffness (6). However, no double-blinded studies evaluating this treatment for analgesia have been performed. The points most relevant to abdominal surgery are those associated with meridian flows crossing or originating in the abdominal area. We therefore tested the hypothesis that application of minute spheres to the Neiguan, Zusanli, Sanyinjiao, and Gongsun points reduces pain and analgesic requirements after open abdominal surgery.
| Methods |
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Before the induction of anesthesia, all participants were instructed in the use of a 100-mm visual analog scale (VAS) for scoring their postoperative pain. On this scale, 0 mm indicates no pain, and 100 mm indicates the worst imaginable pain.
General anesthesia was induced by the IV administration of propofol (3 mg/kg) and succinylcholine (1.5 mg/kg). The trachea was intubated, and mechanical ventilation was adjusted to maintain an end-tidal carbon dioxide partial pressure near 35 mm Hg. Muscle relaxation was maintained with rocuronium, which was titrated to provide one or two twitches in response to supramaximal electrical stimulation of the ulnar nerve at the wrist.
Anesthesia was maintained with volatile anesthesia (desflurane, isoflurane, or sevoflurane) in 30%40% oxygen (balance nitrogen) and fentanyl. The volatile anesthetic and fentanyl were titrated to maintain the bispectral index between 40 and 60. Active surface warming was used to keep the core temperature normothermic (>36°C).
Patients were randomly assigned to treatment with minute spheres or to no treatment (control group). Group assignments were based on computer-generated codes that were kept sealed in sequentially numbered envelopes until completion of surgery. The spheres were stainless steel and 1 mm in diameter (Sakamura Laboratory, Kyoto, Japan).
On completion of surgery, minute spheres were applied in appropriate patients only by our experienced acupuncturists (MS or NM) (6). A single sphere was positioned bilaterally at each of the following points (3):
After the spheres were taped to the above sites, the entire region was covered with a bulky gauze bandage that was in turn covered by a clear plastic adhesive. The adhesive was of a single-use type that could not be reapplied. It was thus readily apparent to the investigators if the dressing had been removed at any point. A similar bulky dressing was applied to patients not assigned to minute sphere therapy.
Surgeons were not permitted to observe whether spheres or a placebo bandage was applied. They thus remained blinded to treatment. The patients were similarly blinded because the sphere or placebo bandage was applied well before emergence from general anesthesia (the spheres were too small to be palpated through the gauze bandage). The attending anesthesiologists were not blinded, but because the spheres were applied at the end of surgery, these anesthesiologists had no effect on the study outcomes. Postoperative pain was treated with IV administration of morphine via a patient-controlled analgesia pump. The pump was loaded with morphine sulfate and set to a 2-mg bolus and 6-min lockout period; no background infusion was used.
All standard anesthesia monitors were used. Core temperature was measured in the distal esophagus. Morphometric characteristics and ASA status were recorded. We also recorded the total intraoperative dose of fentanyl (µg) and the duration of anesthesia and surgery.
Our primary a priori end-points were pain on the first postoperative morning and opioid consumption in the period between the end of surgery and the first postoperative morning. Pain was evaluated with a VAS. Postoperative morphine sulfate consumption was recorded by the patient-controlled analgesia pump.
Secondary end-points were the incidence of postoperative nausea and vomiting (PONV) and the consumption of antiemetic drugs; both were recorded on the first postoperative morning. Other analgesics given concurrently with morphine and their doses were recorded as well. At the end of treatment, patients were asked to guess to which group they had been assigned. Investigators who were fully blinded to treatment evaluated all end-points.
Continuous outcomes in the two treatment groups were compared by using Wilcoxons ranked sum tests because the values were not normally distributed; nominal end points were compared by using
2 or Fishers exact tests. Results are presented as number of patients or median (25th percentile, 75th percentile); P < 0.05 was considered statistically significant.
| Results |
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Morphometric and demographic characteristics were similar in each group, as was intraoperative fentanyl use (Table 1). The fraction of patients requiring analgesics in addition to morphine was similar in the control group (53%) and the minute spheres group (48%). Other analgesics used included ketorolac, meperidine, oxycodone, and acetaminophen; their use was distributed evenly among the groups.
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level of 0.05.
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| Discussion |
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For example, we have previously reported that bilateral electrical stimulation of the lateralization-control point reduces anesthetic requirements (12). Although the reduction was highly statistically significant, the magnitude of the difference was only 11% ± 7%. Auricular acupuncture of the Shen Men, Thalamus, Tranquilizer, and Master Cerebral points also reduced anesthetic requirements by 8.5% ± 7%, an amount that again was of questionable clinical importance (11). Another study evaluated 14 intradermal needles that were inserted 2.5 cm to the left and right of the T9 to L3 spinal vertebrae. Acupuncture with intradermal needles increased the fraction of patients with good pain relief, reduced morphine consumption by 50%, decreased the incidence of postoperative nausea by 20%30%, and reduced plasma cortisol and epinephrine concentrations by 30%50% (13). In contrast, electro-acupuncture at the Zusanli, Yanglingquan, and Kunlun acupuncture points on the legs failed to reduce anesthetic requirements at all (10).
Application of minute spheres to acupoints is an alternative to needle insertion, electrical stimulation, intradermal needles, and digital acupressure. Acupressure with minute spheres is similar in concept to the acupressure beads used at the Nei-Guan (pericardium, P.6) point for treatment of nausea and vomiting. However, the beads we used were far smaller than those used for the treatment of nausea and vomiting. Treatment at the P.6 points has been variously reported as effective (14) or ineffective (15,16). Although this was not statistically significant, those patients given minute sphere therapy in our study had almost 70% fewer vomiting episodes than the control group. This observation suggests that a larger study may have found that minute sphere therapy was beneficial for preventing PONV. Minute gold beads are also sometime implanted in efforts to treat chronic diseases, including arthritis (17). However, technically adequate studies of this treatment have not been published.
Our study is among few that are fully blinded evaluating acupuncture or acupressure. We were able to achieve full double blinding by positioning the minute spheres before patients recovered from anesthesia, out of view of the surgeons and follow-up investigators. Evaluation of the patients impression about their treatment confirmed that blinding was adequate. The results of our study were clear: we failed to identify any significant changes in morphine requirement or in pain scores in the patients treated with minute spheres. We thus conclude that perioperative application of minute spheres to the Neiguan, Zusanli, Sanyinjiao, and Gongsun points does not provide clinically important analgesia after open abdominal surgery.
A limitation of our study is that we evaluated only four acupressure sites. Although these sites were chosen to optimize analgesia after abdominal surgery, it remains possible that superior analgesia could have resulted from stimulation of other sites. An additional limitation is that abdominal surgery produces considerable postoperative pain. Treatment with minute spheres may have proven more effective in patients with less intense pain. Finally, the results may have been more encouraging had we used needle or electrical stimulation. In other words, there may not have been any problem with the four sites we chose or with the pain intensity; instead, our results may simply indicate only that acupressure with minute spheres per se is ineffective.
In summary, patients were randomly assigned to an untreated control group (n = 30) or to minute sphere acupressure (n = 23) at the Neiguan, Zusanli, Sanyinjiao, and Gongsun points. Morphine requirements and pain scores were similar in the control and treatment groups. Minute sphere treatment at the selected points thus failed to provide analgesia after abdominal surgery.
| Acknowledgments |
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The authors appreciate the assistance of Nancy Alsip, PhD, and Gilbert Haugh, MS.
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