Dataset Information

Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial.

ABSTRACT:

Background

The majority of postoperative patients report moderate to severe pain, possibly related to opioid underdosing or overdosing during surgery. Objective guidance of opioid dosing using the Nociception Level (NOL) index, a multiparameter artificial intelligence-driven index designed to monitor nociception during surgery, may lead to a more appropriate analgesic regimen, with effects beyond surgery. We tested whether NOL-guided opioid dosing during general anaesthesia results in less postoperative pain.

Methods

In this two-centre RCT, 50 patients undergoing abdominal surgery under fentanyl/sevoflurane anaesthesia were randomised to NOL-guided fentanyl dosing or standard care in which fentanyl dosing was based on haemodynamics. The primary endpoint of the study was postoperative pain assessed in the PACU.

Results

Median postoperative pain scores were 3.2 (inter-quartile range 1.3-4.3) and 4.8 (3.0-5.3) in NOL-guided and standard care groups, respectively (P=0.006). Postoperative morphine consumption (standard deviation) was 0.06 (0.07) mg kg^-1 (NOL-guided group) and 0.09 (0.09) mg kg^-1 (control group; P=0.204). During surgery, fentanyl dosing was not different between groups (NOL-guided group: 6.4 [4.2] ?g kg^-1vs standard care: 6.0 [2.2] ?g kg^-1, P=0.749), although the variation between patients was greater in the NOL-guided group (% coefficient of variation 66% in the NOL-guided group vs 37% in the standard care group).

Conclusions

Despite absence of differences in fentanyl and morphine consumption during and after surgery, a 1.6-point improvement in postoperative pain scores was observed in the NOL-guided group. We attribute this to NOL-driven rather than BP- and HR-driven fentanyl dosing during anaesthesia.

Clinical trial registration

www.trialregister.nl under identifier NL7845.

SUBMITTER: Meijer F

PROVIDER: S-EPMC7771114 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial.

Meijer Fleur F Honing Maarten M Roor Tessa T Toet Samantha S Calis Paul P Olofsen Erik E Martini Chris C van Velzen Monique M Aarts Leon L Niesters Marieke M Boon Martijn M Dahan Albert A

British journal of anaesthesia 20200917 6

<h4>Background</h4>The majority of postoperative patients report moderate to severe pain, possibly related to opioid underdosing or overdosing during surgery. Objective guidance of opioid dosing using the Nociception Level (NOL) index, a multiparameter artificial intelligence-driven index designed to monitor nociception during surgery, may lead to a more appropriate analgesic regimen, with effects beyond surgery. We tested whether NOL-guided opioid dosing during general anaesthesia results in le ...[more]

PMID: 32950246

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Project description:ObjectiveTo investigate the effect of therapeutic suggestions played to patients through earphones during surgery on postoperative pain and opioid use.DesignBlinded randomised controlled study.SettingFive tertiary care hospitals in Germany.Participants385 of 400 patients consecutively recruited from January to December 2018 who were to undergo surgery for 1-3 hours under general anaesthesia. In the per protocol analysis 191 patients were included in the intervention group and 194 patients in the control group.InterventionThe intervention comprised an audiotape of background music and positive suggestions based on hypnotherapeutic principles, which was played repeatedly for 20 minutes followed by 10 minutes of silence to patients through earphones during general anaesthesia. Patients in the control group were assigned to a blank tape.Main outcome measuresThe main outcome was dose of opioid administered by patient controlled analgesia or nurse controlled analgesia within the first postoperative 24 hours, based on regular evaluation of pain intensity on a numerical rating scale (range 0-10, with higher scores representing more severe pain).ResultsCompared with the control group, the intervention group required a significantly (P=0.002) lower opioid dose within 24 hours after surgery, with a median of 4.0 mg (interquartile range 0-8) morphine equivalents versus 5.3 (2-12), and an effect size (Cohen's d) of 0.36 (95% confidence interval 0.16 to 0.56). The number of patients who needed opioids postoperatively was significantly (P=0.001) reduced in the intervention group: 121 of 191 (63%, 95% confidence interval 45% to 70%) patients in the intervention group versus 155 of 194 (80%, 74% to 85%) in the control group. The number needed to treat to avoid postoperative opioids was 6. Pain scores were consistently and significantly lower in the intervention group within 24 hours after surgery, with an average reduction of 25%. No adverse events were reported.ConclusionsTherapeutic suggestions played through earphones during general anaesthesia could provide a safe, feasible, inexpensive, and non-drug technique to reduce postoperative pain and opioid use, with the potential for more general use. Based on the finding of intraoperative perception by a considerable number of patients, surgeons and anaesthetists should be careful about background noise and conversations during surgery.Trial registrationGerman Clinical Trial Register DRKS00013800.

Project description:Vitreoretinal surgery (VRS) is one of the most widely performed precise procedures in ophthalmic surgery; the majority of cases are carried out under regional anaesthesia (RA) only. However, in specific situations (such as when the patient fails to cooperate with the operator for various reasons), general anaesthesia (GA), alone or in combination with GA (combined general-regional anaesthesia, CGR), is the only safe way to perform VRS. While monitoring the efficacy of an intraoperative rescue opioid analgesia (IROA) during surgery (assessing the adequacy of anaesthesia (AoA)) may be challenging, the surgical pleth index (SPI) is a useful tool for detecting the reaction to noxious stimuli and allows for the rational titration of opioid analgesics (AO) during surgery. The current study investigated the influence of the SPI-based titration of fentanyl (FNT) in combination with various pre-emptive analgesia (PA) techniques on intraoperative pain perception during various stages of VRS performed under AoA. A total of 176 patients undergoing VRS under GA were enrolled in the study. They were randomly assigned to one of the five following study arms: Group GA (control group)-patients who received general anaesthesia alone; Group PBB-GA with preprocedural peribulbar block (with 0.5% bupivacaine and 2% lidocaine); Group T-GA with preventive, topical 2% proparacaine; Group M-GA with a preprocedural intravenous infusion of 1.0 g of metamizole; and Group P-GA with a preprocedural intravenous infusion of 1.0 g of paracetamol. The whole procedure was divided in four stages: Stage 1 and 2-preoperative assessment, PA administration, and the induction of GA; Stage 3-intraoperative observation; Stage 4-postoperative observation. the SPI values were monitored during all stages. The occurrence of nociception (expressed as ∆SPI >15) during various manipulations in the surgical field was observed, as were cumulative doses of rescue analgesia, depending on the PA administered. During the course of VRS, rescue FNT doses varied depending on the stage of surgery and the group investigated. The majority of patients, regardless of their group allocation, needed complementary analgesia during trocar insertion, with Group GA patients requiring the highest doses. Likewise, the highest cumulative doses of IROA were noted during endophotocoagulation in Group GA. Preventive PBB and topical anaesthesia were proven to be most efficient in blunting the response to speculum installation, while topical anaesthesia and paracetamol infusion were shown to be more efficient analgesics during endophotocoagulation than other types used PA. In the performed study, none of the PA techniques used were superior to GA with FNT dosing under the SPI with respect to providing efficient analgesia throughout the whole surgery; there was a necessity to administer a rescue OA dose in both the control and investigated groups.

Project description:BackgroundGeneral anesthesia leads to different effects depending on the drugs used (hypnosis, analgesia, muscle relaxation). While there are validated methods for clinical monitoring and control of hypnosis and muscle relaxation in routine anesthesia, the assessment of analgesia is still mainly based on the interpretation of clinical vital parameters, such as heart rate, blood pressure, perspiration or intraoperative movements of the patient. The present clinical study investigated whether the use of a so-called nociception monitor to record the intraoperative need for analgesics is superior to the previous analysis of vital parameters. The analgesia nociception index (ANI; MDoloris, Lille, France) was used, which is one of several nociception monitors currently on the market for recording the sympathicovagal balance. In the case of the ANI, the measurement is based on the analysis of the heart rate variability (HRV) as a function of breathing. The index is given in the form of a dimensionless score between 0 and 100, where 0 stands for a lack of parasympathetic activity and 100 for a very strong parasympathetic activity. According to the manufacturer, a value between 50-70 under anesthesia corresponds to sufficient intraoperative analgesia.MethodsThis was a clinical prospective randomized study in which 110 patients who underwent laparoscopic hysterectomy under balanced anesthesia using propofol, fentanyl and atracurium for induction and sevoflurane and fentanyl for anesthesia maintenance, were divided into two groups. In the intervention group (ANI group), during the operation analgesics were administered with the aid of the ANI monitor (bolus of 0.1 mg fentanyl if the ANI was < 50), whereas in the comparison group analgesics were administered according to previous clinical parameters (vital parameters, intraoperative defensive movements). The groups were then compared with respect to intraoperative fentanyl consumption (primary outcome), postoperative pain and opioid-induced side effects (measured by the numeric rating scale [NRS]) as well as patient satisfaction on postoperative day 3 (secondary outcome).ResultsThe observations showed a higher total intraoperative consumption of fentanyl in the intervention group, due to a significantly higher number of individual doses (0.54 vs. 0.44 mg, p < 0.001). With respect to the other observation points, there were hardly any differences between the groups, neither with respect to the pain score nor the side effects in the recovery room. At most there was a trend towards a slightly lower pain score at the first measurement point in the recovery room (NRS at 15 min). In the patient survey on the postoperative day 3, there was a difference with respect to the subjectively described reduction in vigilance in the ANI group, but not other side effects or overall satisfaction with the pain therapy.ConclusionIn this group of patients the additional use of the ANI monitor for intraoperative control of analgesia led to an increased consumption of fentanyl compared to the comparison group, without having an impact on the postoperative pain score, opioid-induced side effects or patient satisfaction. An optimization of pain therapy through intraoperative use of the ANI monitoring in hysterectomy patients under balanced anesthesia with sevoflurane and fentanyl could therefore not be proven. Transferability of the results to a much older and/or sicker patient collective remains questionable.

Dataset Information

Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial.

Background

Methods

Results

Conclusions

Clinical trial registration

Publications

Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial.

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