Predicted Versus Non-Predicted Opioid Administration Using Preoperative Pain Sensitivity in Patients Undergoing Gynecological Surgery: A Randomized-Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Preoperative Assessment of Pain Sensitivity
2.3. Randomization and Minimization of Bias
2.4. Anesthetic Procedures
2.5. Postoperative Management Protocol
2.6. Outcome Assessments
2.7. Statistical Analysis
2.8. Sample Size
3. Results
3.1. Opioid Use, Pain Scores and Opioid-Related Side Effects in Predicted versus Non-Predicted Groups
3.2. Effect of the Opioid Dose Given to Sensitive Patients
3.3. Effect of the Opioid Dose Given to Non-Sensitive Patients
3.4. Exploratory Analyses
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Characteristics | Predicted Group (n = 50) | Control Group (n = 59) | p Value |
---|---|---|---|
Age (y) | 48.7 (14.5) | 48.6 (13.3) | 0.995 |
Weight (kg) | 59.1 (9.1) | 59.5 (8.8) | 0.840 |
Height (cm) | 157.3 (6.4) | 158.5 (5.1) | 0.272 |
Body mass index (kg/m2) | 23.9 (3.5) | 23.7 (3.3) | 0.723 |
ASA physical status (I/II) | 37/13 (74%/26%) | 52/7 (88%/12%) | 0.082 |
Type of gynecological surgery | 0.611 | ||
Laparoscopic | 30 (60%) | 40 (68%) | |
Abdominal | 11 (22%) | 12 (20%) | |
Vaginal | 9 (18%) | 7 (12%) | |
Operative time (min) | 93 (54–151) | 95 (65–145) | 0.692 |
Anesthesia time (min) | 130 (85–185) | 135 (105–175) | 0.293 |
Intraoperative remifentanil use (µg) | 725 (500–1000) | 1000 (550–1000) | 0.063 |
Pressure pain threshold (N) | 28.2 (9.2) | 28.6 (9.8) | 0.857 |
Sensitive/Non-sensitive | 29/21 (58%/42%) | 30/29 (51%/49%) | 0.455 |
Higher dose/Lower dose | 29/21 (58%/42%) | 39/20 (66%/34%) | 0.502 |
Use of the correspond regimen to sensitivity | 50 (100%) | 34 (58%) | < 0.0001 |
Hospital stays (d) | 4 (3–5) | 4 (3–5) | 0.905 |
Outcomes | Predicted Group (n = 50) | Control Group (n = 59) | p Value |
---|---|---|---|
Pain score at 3 h postoperatively (NRS) | 5 (2–7) | 5 (2–7) | 0.946 |
Pain score at 24 h postoperatively (NRS) | 3 (2–4.3) | 3 (2–5) | 0.232 |
Pain score at 48 h postoperatively (NRS) | 3 (2–3.3) | 2 (1–4) | 0.491 |
Mean pain score, during the 48 h postoperative period (NRS) | 3.3 (1.8) | 3.5 (1.8) | 0.691 |
Fentanyl consumption via IV PCA, within the first 3 h postoperatively (µg) | 68.5 (45–117.8) | 88 (60–119) | 0.166 |
Fentanyl consumption via IV PCA, 3–24 h postoperatively (µg) | 214.8 (145.5–294.8) | 264 (152–352.5) | 0.170 |
Fentanyl consumption via IV PCA, 24–48 h postoperatively (µg) | 64 (0–246.8) | 222 (0–307.5) | 0.089 |
Total cumulative fentanyl consumption via IV PCA, for the first 48 h period (µg) | 406 (309.8–614.6) | 526.5 (370.5–718.5) | 0.042 |
Nefopam consumption via IV PCA, within the first 3 h postoperatively (mg) | 4.6 (3.0–6.6) | 5.0 (4.0–7.5) | 0.203 |
Nefopam consumption via IV PCA, 3–24 h postoperatively (mg) | 14.4 (8.9–17.8) | 14.6 (11.3–20.0) | 0.401 |
Nefopam consumption via IV PCA, 24–48 h postoperatively (mg) | 5.1 (0.0–18.2) | 14.3 (0.0–19.1) | 0.157 |
Total cumulative Nefopam consumption via IV PCA, for the first 48 h period (mg) | 28.0 (17.5–36.9) | 35.2 (23.7–41.1) | 0.067 |
PCA clamping, for the first 48 h period | 6 (12%) | 10 (16.9%) | 0.648 |
Number of patients requiring rescue analgesics for the first 48 h period | 15 (30%) | 13 (22%) | 0.343 |
Cumulative dose of ketorolac as rescue analgesics for the first 48 h period (mg) | 16.8 (32.7) | 10.7 (22.1) | 0.347 |
Satisfaction score for pain managements a | 77 (67–90) | 70 (57–87) | 0.140 |
Outcomes | Predicted Group (n = 50) | Control Group (n = 59) | p Value |
---|---|---|---|
Nausea at 3 h postoperatively | 9 (18%) | 14 (23.7%) | 0.465 |
Nausea at 24 h postoperatively | 13 (26%) | 20 (33.9%) | 0.371 |
Nausea at 48 h postoperatively | 3 (6%) | 10 (16.9%) | 0.136 |
Nausea during the 48 h postoperative period | 20 (40%) | 31 (52.5%) | 0.191 |
Severity of nausea (NRS) a | 1.3 (0.7–2.8) | 2.3 (1.3–3.0) | 0.076 |
Vomiting | 5 (10%) | 6 (10.2%) | 1.000 |
Administration of rescue antiemetic agents | 5 (10%) | 6 (10.2%) | 1.000 |
Respiratory depression | 3 (6%) | 4 (6.8%) | 1.000 |
Shivering | 7 (14%) | 6 (10.2%) | 0.567 |
Pruritus | 1 (2%) | 2 (3.4%) | 1.000 |
Urinary retention | 5 (10%) | 5 (8.5%) | 1.000 |
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Park, S.-K.; Kim, H.; Yoo, S.; Kim, W.H.; Lim, Y.-J.; Kim, J.-T. Predicted Versus Non-Predicted Opioid Administration Using Preoperative Pain Sensitivity in Patients Undergoing Gynecological Surgery: A Randomized-Controlled Trial. J. Clin. Med. 2021, 10, 585. https://doi.org/10.3390/jcm10040585
Park S-K, Kim H, Yoo S, Kim WH, Lim Y-J, Kim J-T. Predicted Versus Non-Predicted Opioid Administration Using Preoperative Pain Sensitivity in Patients Undergoing Gynecological Surgery: A Randomized-Controlled Trial. Journal of Clinical Medicine. 2021; 10(4):585. https://doi.org/10.3390/jcm10040585
Chicago/Turabian StylePark, Sun-Kyung, Hansol Kim, Seokha Yoo, Won Ho Kim, Young-Jin Lim, and Jin-Tae Kim. 2021. "Predicted Versus Non-Predicted Opioid Administration Using Preoperative Pain Sensitivity in Patients Undergoing Gynecological Surgery: A Randomized-Controlled Trial" Journal of Clinical Medicine 10, no. 4: 585. https://doi.org/10.3390/jcm10040585