Effectiveness of electro-acupuncture compared to sedo-analgesics in relieving pain during shockwave lithotripsy.

The aim of this study was to compare the clinical efficacy of electro-acupuncture (EA) with the combination of tramadol+midazolam (TM) for pain relief during outpatient extracorporeal shockwave lithotripsy (ESWL). A total of 35 patients (20 men, 15 women) with stones located in the pelvicalyceal system of the kidney were randomized prospectively to undergo lithotripsy with a third generation lithotriptor (Stone Lith, smart PCK) after receiving either EA (n=17) or TM (n=18) for sedation and analgesia. EA treatment was applied to patients by the same licensed acupuncturist 30 min prior to ESWL in group EA. Tramadol (1.5 mg/kg) 30 min before the start of lithotripsy and midazolam (0.06 mg/kg) 5 min prior to ESWL were given as a sedo-analgesic intravenously to group TM. During ESWL, blood pressure, heart rate, pain and sedation levels were measured at baseline and every 15 min thereafter. The pain intensity perceived during lithotripsy was evaluated using a visual analog scale (VAS). There was no statistical differences in the diameters of the stones and age of the patients between groups (P=0.590; P=0.568, respectively). In the EA group, the median of maximum energy level achieved was 16.0 kV (range 10-23 kV), while it was 18.0 kV (range 10-20 kV) in the TM group. There was no statistically significant difference between the maximum energy levels applied to the patients during ESWL (P=0.613). The median numbers of shockwaves were 2,114 (range 1,100-3,800) and 2,200 (range 1,500-3,200) in the EA and TM groups, respectively. In the TM group, the numbers of shockwaves used were higher than in group EA during ESWL. However, this difference was not significant (P=0.732). VAS scores were consistently lower in the EA group compared with the TM group throughout the ESWL procedure. The median VAS score was 5.0 (range 1-10) in the EA group while it was 8.0 (range 2-10) in the TM group. The patients who underwent EA had lower median scores of VAS than patients who took only conservative treatment, but this difference was not significant (P=0.245). When both groups were compared for stone-free rates, no significant difference was found [82.3% (14/17) for group EA, 88.8% (16/18) for group TM] (P=0.658). Durations of ESWL procedures were similar in both groups [median 27.4 min (range 15.7-34.3) in group EA vs 27.1 min (range 16.1-33.6) in group TM] (P=0.517). No side effects was seen in any patient who received EA. Side effects such as mild orthostatic hypotension and dizziness occurred in patients given sedo-analgesia, but these were not severe enough to require any patient to be excluded from the study. Our study shows that EA is an effective method for inducing sedation with analgesia without any demonstrable side effects.

RCT Entities:   Population Interventions Outcomes