| Methods |
Design: four group parallel trial
Purpose: examine the effect of transcutaneous acupoint electrical stimulation (TAES) on postoperative analgesic requirement |
| Participants |
Patients: patients having undergone lower abdominal surgical procedures
Baseline comparability: yes |
| Interventions |
Placebo: TAES without electrical stimulation
Untreated: no TAES
Experimental: TAES with electrical stimulation (low and high)
(Co‐intervention: standard operational procedures) |
| Outcomes |
Total opoid requirement (in equivalents of mg hydromorphone) in 24 hours
Morphine (mg) delivered by PCA (patient controlled analgesia) device
Number of times patients used PCA device (patient controlled analgesia)
Supplemental opioid analgesics (i.m.)
Supplemental oral analgesics
Duration of PCA
Duration of use of TAES
Duration of stay in postanaesthesia care unit
Duration of hospital stay
Pain, 100 mm VAS
Fatigue, 100 mm VAS
Discomfort, 100 mm VAS
Follow‐up questionnaire |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
‘computer‐generated randomization sequence' |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/TAES) |
| Incomplete outcome data addressed?
All outcomes |
High risk |
|
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
Low risk |
N = 51 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
|
