Cost-Effectiveness and Cost-Utility Analyses in Thailand of Continuous Intrathecal Morphine Infusion Compared with Conventional Therapy in Cancer Pain: A 10-year Multicenter Retrospective Study.

Background: Because of the high initial cost of intrathecal drug delivery (ITDD) therapy, this study investigated the cost-effectiveness and cost-utility of ITDD therapy in refractory cancer pain management in Thailand over the past 10 years. Methods: The retrospective study was conducted in patients with cancer pain who underwent ITDD therapy from January 2011 to 2021 at three university hospitals. Clinical outcomes included the numerical rating scale (NRS), Palliative Performance Scale, and the EQ-5D. The direct medical and nonmedical as well as indirect costs were also recorded. Cost-effectiveness and cost-utility analyses were performed comparing ITDD therapy with conventional therapy (extrapolated from costs of the same patient before ITDD therapy) from a societally oriented economic evaluation. Results: Twenty patients (F:M: 10:10) aged 60 ± 15 years who underwent implantation of an intrathecal percutaneous port (IT port; n = 15) or programmable intrathecal pump (IT pump; n = 5) were included. The median survival time was 78 (interquartile range = 121-54) days after ITDD therapy. At 2-month follow-up, the incremental cost-effectiveness ratio (ICER)/pain reduction of an IT port (US$2065.36 (CA$2829.54)/2-point NRS reduction/lifetime) was lower than for patients with an IT pump (US$5479.26 (CA$7506.58)/2-point NRS reduction/lifetime) compared with continued conventional therapy. The ICER/quality-adjusted life years (QALYs) gained for an IT port compared with conventional treatment was US$93,999.31(CA$128,799.06)/QALY gained, which is above the cost-effectiveness threshold for Thailand. Conclusion: The cost-effectiveness and cost-utility of IT port therapy for cancer pain was high relative to the cost of living in Thailand, above the cost-effectiveness threshold. Prospective cost analysis studies enrolling more patients with diverse cancers that investigate the benefit of early ITDD therapy with devices over a range of prices are warranted.

Contexte: En raison du coût initial élevé du traitement par administration intrathécale de médicaments (AIM), cette étude a étudié le rapport coût-efficacité et le rapport coût-utilité du traitement par AIM dans la prise en charge de la douleur cancéreuse réfractaire en Thaïlande au cours des 10 dernières années.Méthodes: L'étude rétrospective a été menée auprès de patients souffrant de douleur cancéreuse ayant subi un traitement par AIM de janvier 2011 et 2021 dans trois hôpitaux universitaires. Les résultats cliniques comprenaient l'échelle d'évaluation numérique (EEN), l'échelle de performance palliative et l'EQ-5D. Les coûts médicaux et non médicaux directs et indirects ont également été consignés. Les analyses coûts-efficacité et coût-utilité ont été effectuées en comparant le traitement par AIM au traitement conventionnel (extrapolé à partir des coûts pour le même patient avant le traitement par AIM) à partir d'une évaluation économique sociétale.Résultats: Vingt patients (F : M : 10 : 10) âgés de 60 ± 15 ans ayant subi l'implantation d'un port percutané intrathécal (port IT; n = 15) ou d'une pompe intrathécale programmable (pompe IT; n = 5) ont été inclus. Le temps de survie médian était de 78 jours (intervalle interquartile = 121­54) après le traitement par AIM. À deux mois de suivi, le ratio coût-efficacité incrémental (RCEI/réduction de la douleur d'un port IT (2 065,36 $ US (2 829,54 $ CA) /réduction de 2 points sur l'EEN/durée de vie) était inférieur à celui des patients avec une pompe IT (5479,26 $ US (7506,58 $ CA) /réduction de 2 points sur l'EEN/durée de vie) comparativement au traitement conventionnel en continu. Le RCEI/année de vie pondérée par la qualité (AVPQ) gagnée pour un port IT comparativement au traitement conventionnel était de 93 999,31 $ US (128 799,06 $ CA) /AVPQ gagné, ce qui est au-dessus du seuil de rentabilité pour la Thaïlande.Conclusion: Le rapport coût-efficacité et le rapport coût-utilité du traitement par port IT pour la douleur cancéreuse étaient élevés par rapport au coût de la vie en Thaïlande, soit au-dessus du seuil de rentabilité. Les études d'analyse de coût prospectives portant sur un plus grand nombre de patients atteints de divers cancers qui étudient les avantages des traitements par AIM précoces à l'aide d'appareils de prix différents sont justifiées.

Intravenous lidocaine bolus for reducing nefopam-induced venous pain: A randomized, intrasubject comparison trial.

Background and Aims: Intravenous nefopam reduces postoperative pain and opioid consumption but can cause infusion-related pain. We aimed to investigate whether lidocaine can effectively reduce this pain. Material and Methods: This prospective, randomized, double-blind, controlled, intrasubject comparison trial included 42 patients (20-60 years) undergoing elective surgery under regional or peripheral anesthesia. In the postanesthesia care unit, two 50 mL syringes containing nefopam (20 mg) diluted in saline (100 mL) were sequentially infused in 15 min into venous catheters in the left and right arms. Patients were randomly assigned to the "left side" or "right side" group based on the arm in which a bolus of 1% lidocaine (2 mL) (study group) was administered before nefopam infusion. Normal saline (2 mL) was administered on the control side. Numerical Rating Scale scores and the incidence of pain (scores > 3) and nausea or vomiting were recorded at 1, 5, 10, and 15 min. Results: The analysis included 42 patients (84 infusions). Compared with the placebo, lidocaine lowered the mean infusion-related pain at 1 (0.07 vs. 2.21, P < 0.001), 5 (2 vs. 4.21, P < 0.001), 10 (2.02 vs. 3.95, P < 0.001), and 15 min (1.62 vs. 3.16, P = 0.003). At 5 min, significantly higher percentages of infusion sites with moderate and higher pain scores (> 3) were observed on the control side (30.95% vs. 14.29%, P = 0.000). Seven patients exhibited nausea or vomiting (16.7%). Conclusion: For the nefopam infusion rate and concentration that we used, a 20 mg lidocaine pretreatment bolus significantly reduces infusion-related pain.

Perioperative Intravenous Nefopam on Pain Management and Ambulation after Open Spine Surgery: A Randomized Double-Blind Controlled Study.

STUDY DESIGN: This was a randomized double-blind controlled study. PURPOSE: This study was designed to evaluate the effects of intravenous nefopam regarding its ability to reduce morphine consumption and postoperative pain and improve recovery in patients undergoing open spine surgery. OVERVIEW OF LITERATURE: Multimodal analgesia, including nonopioid medications, is essential for pain management in spine surgery. Evidence regarding the use of intravenous nefopam in open spine surgery as part of enhanced recovery after surgery is lacking. METHODS: In this study, 100 patients undergoing lumbar decompressive laminectomy with fusion were randomized into two groups. The nefopam group received 20-mg intravenous nefopam diluted in 100-mL normal saline intraoperatively, followed by 80-mg nefopam diluted in 500-mL normal saline, administered as a continuous infusion postoperatively for 24 hours. The control group received an identical volume of normal saline. Postoperative pain was managed using intravenous morphine via patient-controlled analgesia. Morphine consumption in the first 24 hours was recorded as the primary outcome. Secondary outcomes, including postoperative pain score, postoperative function, and length of hospital stay (LOS), were assessed. RESULTS: No statistically significant differences in the total morphine consumption and postoperative pain score in the first 24 hours postoperatively between the two groups. At the post-anesthesia care unit (PACU), the nefopam group demonstrated lower pain scores while at rest (p =0.03) and upon movement (p =0.02) than the normal saline group. However, the severity of postoperative pain between the two groups was similar from postoperative day 1 to day 3. LOS was significantly shorter in the nefopam group than in the control group (p <0.01). The time to first sitting and walking and PACU discharge between the two groups were comparable. CONCLUSIONS: Perioperative intravenous nefopam demonstrated significant pain reduction during the early postoperative period and shortened LOS. Nefopam is considered safe and effective as a part of multimodal analgesia in open spine surgery.

Ultrasound-guided pulsed radiofrequency of cervical nerve root for cervical radicular pain: a prospective randomized controlled trial.

BACKGROUND CONTEXT: Pulsed radiofrequency (PRF) on cervical dorsal root ganglion (DRG) for pain management in cervical radicular pain is mainly performed via a transforaminal approach under fluoroscopic guidance. Ultrasound-guidance periradicular cervical nerve root intervention raises concern about the neuromodulatory effect. This study aims to evaluate the effectiveness and duration of pain relief between PRF treatment and steroid injection on the cervical nerve roots. PURPOSE: To evaluate the efficacy of pulsed radiofrequency for cervical radicular pain. STUDY DESIGN: A prospective, double-blinded, randomized controlled clinical trial PATIENT SAMPLE: Patients who underwent ultrasound-guided periradicular cervical nerve root PRF or steroid injection from January 2020 to May 2021 at King Chulalongkorn Memorial Hospital (KCMH), Bangkok, Thailand. OUTCOME MEASURES: The primary outcome was the pain score at 3 months postprocedure. The secondary outcomes were the duration of pain relief of at least 50%, pain scores at other time points after pain intervention, the amount of rescue pain medications, procedural time, and complications. METHOD: Forty-two patients who presented with chronic cervical radicular pain were prospectively randomized into the PRF and steroid groups. Patients in the PRF group received PRF treatment at 42°C for 4 minutes, followed by the injection of 2% lidocaine 1.5 mL and dexamethasone 10 mg to the targeted cervical nerve root. The steroid group received the same injectate. Patients and pain assessors were blinded. The numerical rating scale (NRS) and the Neck Disability Index (NDI) questionnaires were used for pain intensity and neck functional assessment before and after the procedure. Pain reduction was recorded up to a 9-month follow-up. RESULTS: Data analysis was obtained from 20 and 21 patients receiving PRF and steroid treatment, respectively. At 3-month postprocedure, there were 70% of patients in the PRF group reported 50% pain reduction compared with 23.8% of patients in the steroid group (p<.01). Moreover, patients in the PRF group had significantly less pain (NRS 2.8±2.7) compared with patients in the steroid group (NRS 5.5±2.6) (p=.01). The neck disability index demonstrated significant improvement at 3 and 6 months (p<.01) after PRF treatment compared with steroid injection alone. The duration, in which pain relief was at least 50%, was significantly longer in patients who received PRF treatment (6.0±4.1 months) compared with those in the steroid group (2.3±2.1 months) (p<.01). CONCLUSION: Ultrasound-guided periradicular cervical nerve root PRF exhibited a neuromodulatory effect and was considered effective for patients with cervical radicular pain. It provided a longer duration of pain relief and improvement of neck function for up to 6 months.

Analgesic Effect of Intravenous Nefopam for Postoperative Pain in Minimally Invasive Spine Surgery: A Randomized Prospective Study.

STUDY DESIGN: Randomized double-blind control study. PURPOSE: To evaluate the effects of nefopam on reducing morphine consumption and postoperative pain in patients undergoing minimally invasive spine surgery (MISS) and to evaluate its effects on enhanced recovery after spine surgery. OVERVIEW OF LITERATURE: Enhanced recovery after surgery (ERAS) has become a major goal for spine surgery. Multimodal pain management combining non-opioid analgesics is a key element of this. However, there is little evidence regarding the use of nefopam in spine surgery as part of an ERAS protocol. METHODS: One hundred patients undergoing MISS were randomized into two groups. Patients in the nefopam group received 20 mg of intravenous nefopam diluted in 100 mL of normal saline intraoperatively, followed by 80 mg of nefopam diluted in 500 mL of normal saline, given as a continuous infusion postoperatively for 24 hours. The control group received an identical volume of normal saline. Postoperative pain was managed by patient-controlled analgesia in the form of intravenous morphine. Morphine consumption in the first 24 hours was recorded as a primary outcome. Secondary outcomes regarding ERAS were also collected. RESULTS: There were no significant differences in either total morphine consumption or postoperative pain score in the first 24 hours postoperatively between patients receiving nefopam and the control group. Morphine consumption in patients receiving nefopam was 13.54±10.64 mg compared with 15.86±16.2 mg in the control group (p=0.41). Time to postanesthetic care unit discharge, times to first sitting and walking, length of hospital stay, as well as duration of Foley catheter use and time until drain removal were also similar. There were no serious adverse effects of nefopam compared with normal saline. CONCLUSIONS: Nefopam did not significantly reduce opioid consumption or postoperative pain score. Adding nefopam as part of multimodal analgesia did not show beneficial effects for enhancing recovery after spine surgery.

Effects of Combined Lower Thoracic Epidural/General Anesthesia on Pain Control in Patients Undergoing Elective Lumbar Spine Surgery: A Randomized Controlled Trial.

STUDY DESIGN: Randomized controlled trial. OBJECTIVE: Our objective was to compare postoperative pain relief and operating field condition of single-shot, low-thoracic epidural anesthesia combined with general anesthesia versus general anesthesia alone. SUMMARY OF BACKGROUND DATA: Prior studies have suggested that continuous epidural analgesia provides better postoperative pain relief and less intraoperative blood loss, but with the risk of the epidural catheter contaminating the surgical field. METHODS: A total of 22 patients scheduled for elective lumbar spine surgery were enrolled and randomly allocated into two groups. Group B (block) received a single-shot epidural block with 0.25% bupivacaine plus 4 mg of morphine with a total volume of 10 mL before receiving general anesthesia with desflurane, and cisatracurium. Group G (general) received general anesthesia alone with desflurane, cisatracurium, and any systemic analgesia deemed appropriate by the attending anesthesiologist. Postoperative pain score, opioid consumption, intraoperative blood loss, surgical field rating score, and other side effects were recorded at the postanesthesia care unit (PACU) and at 24 hours postoperatively. RESULTS: Both groups were comparable for age, sex, body mass index, and American Society of Anaesthesiologists physical status. Fentanyl consumption was significantly lower (P < 0.05) for group B (block) at the PACU and 24 hours. Mean fentanyl consumption at PACU was 20 µg for group B and 85 µg for group G. At 24 hours mean fentanyl consumption was 80 µg for group B and 386 µg for group G. Pain measured with numerical rating scale, surgical field rating score, blood loss, and complications were similar in both groups. CONCLUSION: Single-shot low-thoracic epidural anesthesia combined with general anesthesia provides better pain control than general anesthesia alone. LEVEL OF EVIDENCE: 2.