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Comparison of the Efficacy and Safety of a Pharmacokinetic Model-Based Dosing Scheme Versus a Conventional Fentanyl Dosing Regimen For Patient-Controlled Analgesia Immediately Following Robot-Assisted Laparoscopic Prostatectomy: A Randomized Clinical Trial.

ABSTRACT: Conventional, intravenous, patient-controlled analgesia, which is only administered by demand bolus without basal continuous infusion, is closely associated with inappropriate analgesia. Pharmacokinetic model-based dosing schemes can quantitatively describe the time course of drug effects and achieve optimal drug therapy. We compared the efficacy and safety of a conventional dosing regimen for intravenous patient-controlled analgesia that was administered by demand bolus without basal continuous infusion (group A) versus a pharmacokinetic model-based dosing scheme performed by decreasing the dosage of basal continuous infusion according to the model-based simulation used to achieve a targeted concentration (group B) following robot-assisted laparoscopic prostatectomy.In total, 70 patients were analyzed: 34 patients in group A and 36 patients in group B. The postoperative opioid requirements, pain scores assessed by the visual analog scale, and adverse events (eg, nausea, vomiting, pruritis, respiratory depression, desaturation, sedation, confusion, and urinary retention) were compared on admission to the postanesthesia care unit and at 0.5, 1, 4, 24, and 48 h after surgery between the 2 groups. All patients were kept for close observation in the postanesthesia care unit for 1 h, and then transferred to the general ward.The fentanyl requirements in the postanesthesia care unit for groups A and B were 110.0 ± 46.4 μg and 77.5 ± 35.3 μg, respectively. The pain scores assessed by visual analog scale at 0.5, 1, 4, and 24 h after surgery in group B were significantly lower than in group A (all P < 0.05). There were no differences in the adverse events between the 2 groups.We found that the pharmacokinetic model-based dosing scheme resulted in lower opioid requirements, lower pain scores, and no significant adverse events in the postanesthesia care unit following robot-assisted laparoscopic prostatectomy in comparison with conventional dosing regimen.

SUBMITTER: Jin SJ

PROVIDER: S-EPMC4718305 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Comparison of the Efficacy and Safety of a Pharmacokinetic Model-Based Dosing Scheme Versus a Conventional Fentanyl Dosing Regimen For Patient-Controlled Analgesia Immediately Following Robot-Assisted Laparoscopic Prostatectomy: A Randomized Clinical Trial.

Jin Seok-Joon SJ Lim Hyeong-Seok HS Kwon Youn-Ju YJ Park Se-Ung SU Yi Jung-Min JM Chin Ji-Hyun JH Hwang Jai-Hyun JH Kim Young-Kug YK

Medicine 20160101 2

Conventional, intravenous, patient-controlled analgesia, which is only administered by demand bolus without basal continuous infusion, is closely associated with inappropriate analgesia. Pharmacokinetic model-based dosing schemes can quantitatively describe the time course of drug effects and achieve optimal drug therapy. We compared the efficacy and safety of a conventional dosing regimen for intravenous patient-controlled analgesia that was administered by demand bolus without basal continuous ...[more]

PMID: 26765479

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Project description:IntroductionRobot-assisted laparoscopic prostatectomy (RALP) offers potential cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP. There is reluctance, however, to perform NS RALP when there are concerns that the cancer extends beyond the capsule of the prostate into the NVB, as NS RALP in this instance increases the risk of a positive surgical margin (PSM). The NeuroSAFE technique involves intraoperative fresh-frozen section analysis of the posterolateral aspect of the prostate margin to assess whether cancer extends beyond the capsule. There is evidence from large observational studies that functional outcomes can be improved and PSM rates reduced when the NeuroSAFE technique is used during RALP. To date, however, there has been no randomised controlled trial (RCT) to substantiate this finding. The NeuroSAFE PROOF feasibility study is designed to assess whether it is feasible to randomise men to NeuroSAFE RALP versus a control arm of 'standard of practice' RALP.MethodsNeuroSAFE PROOF feasibility study will be a multicentre, single-blinded RCT with patients randomised 1:1 to either NeuroSAFE RALP (intervention) or standard RALP (control). Treatment allocation will occur after trial entry and consent. The primary outcome will be assessed as the successful accrual of 50 men at three sites over 15 months. Secondary outcomes will be used to aid subsequent power calculations for the definitive full-scale RCT and will include rates of NS; PSM; biochemical recurrence; adjuvant treatments; and patient-reported functional outcomes on potency, continence and quality of life.Ethics and disseminationNeuroSAFE PROOF has ethical approval (Regional Ethics Committee reference 17/LO/1978). NeuroSAFE PROOF is supported by National Institute for Healthcare Research Research for Patient Benefit funding (NIHR reference PB-PG-1216-20013). Findings will be made available through peer-reviewed publications.Trial registration numberNCT03317990.

Project description:IntroductiondHACM is a source of factors including cytokines that allow anti-inflammatory and proliferative elements to be utilized for wound and ulcer management. We present our experience of using dHACM in a cohort of patients undergoing nerve-sparing (NS) robot-assisted laparoscopic prostatectomy (RALP). Our objective is to investigate the functional and oncological outcomes of NS after placing amniotic or dehydrated human amnion/chorion membrane (dHACM) on preserved neurovascular bundles (NVBs). From 2013 to 2019, our institution performed transperitoneal multi-port da Vinci robotic prostatectomy. The NVBs are spared by releasing their fascial planes posteriorly, followed by an anterior release of the plane at a similar level. Once the retrograde release of the NVB is performed then 599 patients underwent placement of dHACM graft (AmnioFix by MiMedx, Marietta, GA, USA). The graft was cut into two 4 × 1 cm pieces and laid over the NVB as a wrap. In order to inform the urological community of oncological and functional outcomes, we excluded patients with less than 12 months follow up (n = 64), benign prostatic hyperplasia (n = 5), and unilateral NS (n = 1). 529 (88%) patients were included in this study who underwent a partial or full bilateral NS with dHACM. 529 patients were followed-up for a median (IQR) of 42 months (25-89). Demographics include median (IQR) age 57 years (52-62), median preoperative SHIM score of 24 (21-15), and AUASS of 5 (2-11). Full NS was performed in 74% (391/529). Pathological staging was pT2 = 399 (75%), pT3a = 107 (20%), pT3b = 19 (4%) and pT4 = 4 (1%) with N1 = 3 (0.6%). The number of patients with PSM was 86 (16%), and the overall BCR in the entire cohort was 10%. Postoperatively, 434 (82%) were sexually active. Median time to potency was 119 (37-420) days and time to continence was 42 (23-91) days. Regarding full vs partial NS: median post op SHIM score 18 (13-20) vs 15 (6-20), median time to potency 92 (35-365) days vs 184 (42-560) days, and median time to continence 42 (23-91) days vs 44 (30-92) days. Age > 55 vs ≤ 55 years: median post op SHIM score 18 (12-20) vs 15 (10-20), median time to potency 167 days (42-549) vs 80 (35-288) days, and median time to continence 42 (25-116) days vs 42 (29-76) days. In our series the application of amniotic membrane/dHACM has led to acceptable post RALP outcomes. The BCR rate of 10% in addition to the recovery of potency at a median time of 3 months and continence at 6 weeks is an encouraging result of dHACM. Our findings indicate that dHACM allowed for an even faster period for continence recovery which was independent of grade of NS. Future comparative studies may further assess the impact of new amniotic membrane types on the functional and oncological outcomes after RALP.

Project description:BackgroundWe explored the analgesic outcomes on postoperative day (POD) 1 in patients undergoing robot-assisted laparoscopic prostatectomy (RALP) who received intravenous patient-controlled analgesia (IV-PCA), rectus sheath bupivacaine block (RSB), or intrathecal morphine with bupivacaine block (ITMB).MethodsThis was a prospective, observational clinical trial. Patients were divided into three groups: IV-PCA (n = 30), RSB (n = 30), and ITMB (n = 30). Peak pain scores at rest and with coughing, cumulative IV-PCA drug consumption, the need for IV rescue opioids, and Quality of Recovery-15 (QoR-15) questionnaire scores collected on POD 1 were compared among the groups.ResultsThe preoperative and intraoperative findings were comparable among the groups; the ITMB group required the least remifentanil of all groups. During POD 1, the ITMB group reported lower levels of pain at rest and with coughing, compared with the other two groups. During POD 1, incidences of severe pain at rest (10.0% vs. 23.3% vs. 40.0%) and with coughing (16.7% vs. 36.7% vs. 66.7%) were the lowest in the ITMB group compared with the RSB and IV-PCA groups, respectively. After adjustment for age, body mass index, diabetes mellitus, hypertension, and intraoperative remifentanil infusion, severe pain at rest was 0.167-fold less common in the ITMB group than in the IV-PCA group, while pain with coughing was 0.1-fold lower in the ITMB group and 0.306-fold lower in the RSB group, compared with the IV-PCA group. The ITMB group required lower cumulative IV-PCA drug infusions and less IV rescue opioids, while exhibiting a better QoR-15 global score, compared with the other two groups. Complications (nausea and pruritus) were significantly more common in the ITMB group than in the other two groups; however, we noted no ITMB- or RSB-related anesthetic complications (respiratory depression, post-dural headache, nerve injury, or puncture site hematoma or infection), and all patients were assessed as Clavien-Dindo grade I or II during the hospital stay.ConclusionAlthough ITMB induced complications of nausea and pruritus, this analgesic technique provided appropriate pain relief that enhanced patient perception related to early postoperative recovery.Trial registrationClinical Research Information Service, Republic of Korea, (approval number: KCT0005040 ) on May 20, 2020.

Dataset Information

Comparison of the Efficacy and Safety of a Pharmacokinetic Model-Based Dosing Scheme Versus a Conventional Fentanyl Dosing Regimen For Patient-Controlled Analgesia Immediately Following Robot-Assisted Laparoscopic Prostatectomy: A Randomized Clinical Trial.

Publications

Comparison of the Efficacy and Safety of a Pharmacokinetic Model-Based Dosing Scheme Versus a Conventional Fentanyl Dosing Regimen For Patient-Controlled Analgesia Immediately Following Robot-Assisted Laparoscopic Prostatectomy: A Randomized Clinical Trial.

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