Figure 1.
CONSORT flow diagram of participant enrollment, randomization, allocation, follow-up, and analysis in patients undergoing breast conservative surgery. Seventy participants were randomized equally to tapentadol and placebo groups, with no losses to follow-up.
Table-I
Baseline demographic and perioperative characteristics of study participants (Group A = Tapentadol, Group B= Placebo).
| Group A (n=35) | Group B (n=35) | p Value | |
|---|---|---|---|
| Age, years;mean(SD) | 40.97±9.10 | 45.83±10.93 | 0.041 |
| BMI, kg/m2;mean(SD) | 25.96±3.43 | 26.75±4.73 | 0.426 |
| ASA 2;n(%) | 34(97.1%) | 35(100%) | 0.314 |
| Duration of surgery, minutes;mean(SD) | 64.57±24.86 | 64.69±24.05 | 0.984 |
Table II.
Postoperative pain scores measured by Numerical Rating Scale (NRS) at predefined time intervals following surgery (Group A = Tapentadol, Group B= Placebo).
| Time intervals (hours) | Pain score, Group A (n=35) Mean ± SD | Pain Score, Group B (n=35) Mean ± SD | Mean Difference in Pain scores. | 95%CI | p-value |
|---|---|---|---|---|---|
| 1 | 1.89 ± 0.83 | 2.46 ± 1.15 | −0.571 | −1.050 to −0.093 | 0.020 |
| 2 | 1.31 ± 0.63 | 1.66 ± 0.87 | −0.343 | −0.707 to 0.021 | 0.064 |
| 3 | 1.06 ± 0.24 | 1.23 ± 0.43 | −0.171 | −0.336 to −0.006 | 0.042 |
| 4 | 1.00 ± 0.00 | 1.03 ± 0.17 | −0.029 | −0.087 to 0.029 | 0.324 |
Figure 2.
Mean postoperative pain scores measured using the Numerical Rating Scale (NRS: range 0–10) at 1, 2, 3, and 4 hours after surgery in patients receiving preoperative tapentadol (Group A) versus placebo (Group B). Data are presented as mean values and standard deviation (SD). Lower scores indicate less pain. Pain scores were significantly lower in the tapentadol group at 1 and 3 hours postoperatively (p < 0.05).
Figure 3.
Mean intraoperative morphine consumption (mg) in patients receiving preoperative tapentadol (Group A) versus placebo (Group B) during breast conservative surgery. Data are presented as mean morphine dose in milligrams, with standard deviation (SD).
Table III.
Comparison of intraoperative morphine consumption and time to first rescue analgesia between Group A: Tapentadol and Group B: Placebo.
| Group A (n=35) Mean ± SD | Group B (n=35) Mean ± SD | Mean Difference | 95%CI | p-value | |
|---|---|---|---|---|---|
| Intra-operative morphine consumption(mg) | 1.11 ± 1.53 | 3.36 ± 1.60 | −2.24 | −2.99 to −1.49 | <0.001 |
| Time to first rescue analgesia postoperatively(minutes) | 58.0 ± 21.7 | 43.5 ± 27.3 | 14.5 | −14.4 to 43.4 | 0.290 |