Real-World Evidence on the Efficacy and Tolerability of Tramadol/Dexketoprofen (TRAM/DKP) Fixed-Dose Combination for the Management of Acute Non-surgical Pain in Asian Patients: A Multicentre Retrospective Case Series.

INTRODUCTION: Multimodal analgesia is key in the effective management of acute pain. Previous clinical trials have demonstrated good results with the use of a fixed-dose combination (FDC) of tramadol 75 mg and dexketoprofen 25 mg (TRAM/DKP) in acute pain management. However, there is a dearth of real-world evidence on the efficacy and safety of this combination in the management of acute non-surgical pain, especially among Asian patients. The case series reported herein investigates the real-world experiences of physicians and Asian patients with the use of TRAM/DKP FDC in the management of acute non-surgical pain. METHODS: Data were collected retrospectively on 11 Asian patients across multiple hospitals who had received a short course of TRAM/DKP FDC for acute non-surgical orthopaedic and non-orthopaedic pain. Data on baseline characteristics, medical history, treatment regimen, clinical outcomes, and patient satisfaction were compiled and shared at a peer-to-peer expert meeting in October 2022. RESULTS: All patients experienced a reduction in pain intensity and were very satisfied with pain management, with a mean satisfaction score of 4.3/5. Five patients (range: 63-74 years) experienced mild adverse events, including nausea, vomiting, and dizziness, which resolved with no need for additional treatment in the majority of cases. No serious adverse events were recorded. CONCLUSION: Asian patients with acute non-surgical orthopaedic and non-orthopaedic pain achieved good pain control with TRAM/DKP FDC. The regimen was well tolerated, and patients reported high levels of satisfaction with the outcomes, indicating that TRAM/DKP FDC is an effective choice for the control of acute non-surgical pain in Asian patients.

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.

Effects of Platelet-Rich Plasma in Tear Size Reduction in Partial-Thickness Tear of the Supraspinatus Tendon Compared to Corticosteroids Injection.

OBJECTIVES: Corticosteroid (CS) injection is commonly used in partial-thickness rotator cuff tears to decrease pain. However, this could result in unwanted side effects, such as tendon rupture. Alternatively, platelet-rich plasma (PRP) injection is frequently used to treat tendinopathies because it enhances healing. This study aimed to compare the differences in tear size and functional scores between intralesional PRP and subacromial CS injections. METHODS: Patients with symptomatic partial-thickness tears of the supraspinatus tendon who underwent conservative treatment for ≥ 3 months were enrolled. All patients underwent magnetic resonance imaging (MRI) to confirm the diagnosis. Fourteen and 15 patients were randomized to receive intralesional PRP and subacromial CS injections, respectively. Tears were measured in the coronal and sagittal planes. The patients underwent another MRI 6 months after the injection. Tear size was compared between the two MRI results. The American Shoulder and Elbow Surgeons Shoulder score (ASES) and Constant-Murley score (CMS) were also obtained. RESULTS: The baseline data were similar between the groups. In the coronal plane, PRP and CS showed tear size reductions of 3.39 mm (P = 0.003) and 1.10 mm (P = 0.18), respectively. In the sagittal plane, PRP and CS showed tear size reductions of 2.97 mm (P = 0.001) and 0.76 mm (P = 0.29), respectively. Functional scores improved 6 months after injection in both groups, but PRP showed better functional scores than CS (P = 0.002 for ASES, P = 0.02 for CS). CONCLUSION: Intralesional PRP injection can reduce the tear size in partial-thickness tears of the supraspinatus tendon. Subacromial steroid injection did not significantly affect the tear size. While CS improved functional scores compared with baseline, PRP resulted in better improvement 6 months post-injection. Trial registration Thai Clinical Trials Registry, TCTR20210428004. Registered 28 April 2021-retrospectively registered, TCTR20210428004 .

Comparison of intrathecal morphine and low-dose bupivacaine with intravenous morphine for postoperative analgesia in laparoscopic liver resection: a randomized controlled trial.

BACKGROUND: Laparoscopic liver surgery has undergone substantial advancements over the past few decades, and the key to this improvement has been an improved understanding of liver anatomy, radiologic imaging, and advancements in anesthesia and postoperative care. This study aimed to compare postoperative opioid consumption in patients receiving intrathecal morphine plus low-dose bupivacaine versus those receiving intravenous morphine. METHODS: In this randomized controlled trial, 40 patients were enrolled and randomly assigned to two groups, of which one received 0.2 mg intrathecal morphine plus 0.25% Marcaine in a total volume of 4 mL and the other received intravenous morphine intraoperatively. Pain relief and patient satisfaction were evaluated using the visual analog scale. Intraoperative blood loss was measured at the end of the surgery while morphine consumption was measured by monitoring intravenous patient-controlled morphine at 12, 24, 36, and 48 h postoperatively. Treatment efficacy and complications were documented. RESULTS: Morphine consumption was significantly different in both groups at all time points, although the pain score did not show any difference. Shoulder pain, a common adverse effect of laparoscopic surgery, was significantly lower in the intrathecal group (25% vs. 75%). Blood loss and patient satisfaction were not different between the groups. However, the intrathecal group showed a significantly higher incidence of intraoperative hypotension. CONCLUSION: Intrathecal morphine with bupivacaine can be used effectively for managing acute post-LLR pain. THAI CLINICAL TRIAL REGISTRY: TCTR20211015004.

Effects of general anesthesia with and without thoracic epidural block on length of stay after open spine surgery: a single-blinded randomized controlled trial.

BACKGROUND CONTEXT: Length of hospital stay (LOS) is an important concern in all types of surgery, and the enhanced recovery after surgery (ERAS) protocol has been developed to improve perioperative management and outcomes, which require multidisciplinary management. In terms of pain control, intraoperative regional anesthesia and postoperative opioid-sparing analgesia are recommended. For open spine surgery, we aimed to combine thoracic epidural analgesia to reduce pain and opioid-related side effects, thereby hastening recovery. PURPOSE: This study aimed to compare the length of hospital stay after open complete laminectomy with fusion between general anesthesia and combined general anesthesia involving a single thoracic epidural injection. DESIGN: A randomized single-blinded controlled study. PATIENT SAMPLE: Thirty-eight patients scheduled for elective open laminectomy with fusion between I and III levels were selected. OUTCOME MEASURES: LOS, postoperative pain, patient-controlled morphine consumption at 24 hours, patient satisfaction score, and other opioid-related side effects were recorded. METHODS: Patients were randomly selected to receive standard general anesthesia (GA) or GA combined with a single-shot thoracic epidural at T11-T12 or T12-L1, a block with 10 mL of 0.25% bupivacaine, and 4 mg of morphine. RESULTS: There were no significant differences in the demographic variables between groups. LOS was significantly lower in the combined epidural and/or GA than in the control group (3.78±0.81 [mean±standard deviation] and 4.79±1.51 days, respectively; p=.017). Numeric rating score (at rest) at the post-anesthesia care unit, 24 hours postoperative morphine consumption (mg), operating time, and blood loss were significantly lower in the epidural group. Patients who received combined epidural and/or GA were more likely to report higher patient satisfaction (p=.008). However, the incidence of intraoperative hypotension was significantly higher in the epidural group (72.2% vs. 21.1%, p=.003). The incidences of adverse events and surgical field rating scores did not differ between the 2 patient groups. CONCLUSIONS: Combined lower thoracic epidural and/or GA in patients undergoing elective lumbar spine surgery was associated with decreased LOS.

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.

Comparison of a Platelet-Rich Plasma Injection and a Conventional Steroid Injection for Pain Relief and Functional Improvement of Partial Supraspinatus Tears.

BACKGROUND: Partial supraspinatus tendon tears have frequently been treated using a subacromial corticosteroid injection or surgery. The clinical use of a platelet-rich plasma (PRP) injection is an alternative treatment method for the condition, despite the paucity of evidence of its efficacy. PURPOSE: To compare pain relief, functional improvement, and complications after an intratendinous PRP injection versus a subacromial corticosteroid injection for partial supraspinatus tears. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 32 patients with partial supraspinatus tears were randomly assigned to receive a leukocyte-poor PRP (LP-PRP) injection or a corticosteroid injection. One patient withdrew from the PRP group, leaving 15 patients in the PRP group and 16 patients in the corticosteroid group. The ultrasound-guided procedures were performed by a single experienced pain physician. Pain relief and functional improvement were evaluated using the visual analog scale (VAS) and the Oxford Shoulder Score (OSS), respectively. Treatment efficacy and complications were documented, and the 2 groups were compared at 1- and 6-month follow-up. RESULTS: There were no differences in VAS and OSS scores between the PRP and corticosteroid groups at 1-month follow-up. However, the PRP group had better scores than the corticosteroid group had on both the VAS and OSS at 6-month follow-up (VAS: 14.5 ± 15.4 vs 37.5 ± 24.9, respectively; OSS: 16.2 ± 3.9 vs 25.0 ± 10.2, respectively; P < .01 for both). Both groups showed significant improvement in VAS and OSS scores from before treatment to 1-month follow-up (mean difference, 35.67 and 11.47 points, respectively, for the PRP group; mean difference, 29.69 and 11.13 points, respectively, for the corticosteroid group; P < .01 for all). The VAS and OSS scores did not change significantly at 6-month follow-up in the corticosteroid group; however, the PRP group showed continued improvement in both VAS and OSS scores between 1- and 6-month follow-up (mean difference, 15.87 and 7.40 points, respectively; P < .01 for both). There were no complications in either group. CONCLUSION: An injection using either a corticosteroid or LP-PRP resulted in a similar reduction in pain and improvement in function at 1 month in patients with a partial supraspinatus tear. However, PRP showed superior benefits over the corticosteroid at 6-month follow-up.

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.