Reduced postoperative pain in patients receiving nociception monitor guided analgesia during elective major abdominal surgery: a randomized, controlled trial

Fuica, Rivka; Krochek, Carlos; Weissbrod, Rachel; Greenman, Dimitri; Freundlich, Andres; Gozal, Yaacov

doi:10.1007/s10877-022-00906-1

Cited by 19 publications

(20 citation statements)

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“…This is pooled analysis of two earlier conducted and published trials with a similar protocol, the SOLAR trial and the Abdomi-Nol trial ( 12 , 13 ). Both studies were prospective, double-blind (the patients and nurses who scored and treated the pain were unaware of the intraoperative treatment), parallel, randomized controlled trials on intraoperative nociception monitoring-guided opioid administration with primary endpoint median pain score in the first 90 min in the PACU and were conducted independently.…”

Section: Methodsmentioning

confidence: 99%

“…The SOLAR trial was conducted at two sites, a tertiary university center and a secondary referral center, both in the Netherlands ( 12 ). The Abdomi-Nol study was performed in a tertiary center in Israel ( 13 ).…”

Section: Methodsmentioning

confidence: 99%

“…Abdomi-Nol study ( 13 ). This study was performed at the Shaare Zedek Medical Center, Jerusalem, Israel, after approval was obtained from the local medical ethics committee.…”

Section: Methodsmentioning

confidence: 99%

“…To strengthen our knowledge on the relationship between NOL-guided analgesic dosing during surgery and postoperative pain scores, we conducted a pooled analysis of two independent, randomized, controlled trials that compared the influence of intraoperative NOL-guided fentanyl to standard of care (SOC) on postoperative pain ( 12 , 13 ). The two studies were equivalent with respect to study protocol and had common efficacy measures ( Supplementary Digital Table S1 ).…”

Section: Introductionmentioning

confidence: 99%

“…The results of both studies were that NOL-guided fentanyl dosing during surgery reduces pain scores in the post-anesthesia care unit (PACU) by 1.4–1.5 pints on an 11-point pain scale (from 0 = no pain to 10 = most severe pain imaginable). While the two studies had an identical design they evaluated 50 patients with predominantly surgical patients in the first study (SOLAR) ( 12 ), and 75 patient with an almost equal distribution among three surgery types (surgical 33%, urology 30% and gynecology 37%) in the second one (AbdomiNol) ( 13 ). The pooling enables to evaluate the effect based on larger sample size with better representation of surgery type, enables us generalizing results to a wider context especially identifying the specific patient populations that benefit from NOL-guided analgesia and leading to improved power to detect whether postoperatively there is less pain following NOL-guided fentanyl dosing.…”

Section: Introductionmentioning

confidence: 99%

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Intraoperative use of the machine learning-derived nociception level monitor results in less pain in the first 90 min after surgery

et al. 2023

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In this pooled analysis of two randomized clinical trials, intraoperative opioid dosing based on the nociception level-index produced less pain compared to standard care with a difference in pain scores in the post-anesthesia care unit of 1.5 (95% CI 0.8–2.2) points on an 11-point scale. The proportion of patients with severe pain was lower by 70%. Severe postoperative pain remains a significant problem and associates with several adverse outcomes. Here, we determined whether the application of a monitor that detects intraoperative nociceptive events, based on machine learning technology, and treatment of such events reduces pain scores in the post-anesthesia care unit (PACU). To that end, we performed a pooled analysis of two trials in adult patients, undergoing elective major abdominal surgery, on the effect of intraoperative nociception level monitor (NOL)-guided fentanyl dosing on PACU pain was performed. Patients received NOL-guided fentanyl dosing or standard care (fentanyl dosing based on hemodynamic parameters). Goal of the intervention was to keep NOL at values that indicated absence of nociception. The primary endpoint of the study was the median pain score obtained in the first 90 min in the PACU. Pain scores were collected at 15 min intervals on an 11-point Likert scale. Data from 125 patients (55 men, 70 women, age range 21–86 years) were analyzed. Sixty-one patients received NOL-guided fentanyl dosing and 64 standard care. Median PACU pain score was 1.5 points (0.8–2.2) lower in the NOL group compared to the standard care; the proportion of patients with severe pain was 70% lower in the NOL group (p = 0.045). The only significant factor associated with increased odds for severe pain was the standard of care compared to NOL treatment (OR 6.0, 95% CI 1.4 −25.9, p = 0.017). The use of a machine learning-based technology to guide opioid dosing during major abdominal surgery resulted in reduced PACU pain scores with less patients in severe pain.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“…Abdomi-Nol study ( 13 ). This study was performed at the Shaare Zedek Medical Center, Jerusalem, Israel, after approval was obtained from the local medical ethics committee.…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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